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MDR Document Management#

With this functionality, you can organize in a document management system (DMS) the Medical Device Regulation (MDR) documents that should be linked to Microsoft Dynamics 365 Business Central1 master records. The feature separates storage and assignment in a way that you can file and open MDR documents in the DMS but link each of them to multiple records in medtec365.

For every link set up between an external document and a header or a line in the app, another MDR document entry will be created—even if setup would allow for more than one entry to be assigned to the same part of a master record. You can, however, have different entries linked to different lines on the record.

When you create follow-on documents, such as posted sales documents, the entries will be linked to them as well. They will also be assigned, for example, to item ledger entries when you post journals for a production order.

By contrast, when you simulate the creation of MDR document entries, you see every entry that could theoretically be created according to setup—regardless of whether it will result in an actual entry later.

Note

You need a separate license before you can use this functionality.

Setup#

MDR conversions#

To set up conversions for master records:

  1. Choose the Search icon, enter MDR Conversion List, and then choose the related link.
  2. On the ribbon, choose New.
  3. Fill in the fields as described in the following table.

General#

Field Description
Item No. Specify the item that base data should be converted for.

If this field is left blank, no other field can be filled in and the lines cannot be edited either. When the field is filled in, the description of the specified item appears as a heading on the conversion card.

Note
If you want to create an entry for an item that a compliance check must be run on and that data maintenance has been completed for, you see a message stating that no conversion can be created.

You then need to choose Edit Item on the ribbon to change the status of data maintenance to In Progress. When you set the status to Completed again, the conversion for the item remains but can no longer be changed and the text ‘Update Completed’ is shown on the conversion card header next to the item description.
Conversion Date Specify when the conversion should be carried out.
Status You can set this field to In Progress or Certified. Other statuses are set automatically (New, Converted, Error). You see an error message if you try to select a status that should be assigned by the system.

New
Set by the system when a new conversion record is created.

Certified
Set manually so that the item is included during conversion. A certified record cannot be edited.

You see an error message if you try to select this status without having filled in a conversion date or a field ID on any of the lines.

In Progress
Set manually so that you can edit a record.

Converted
Set by the system after the item is successfully converted.

Error*
Set by the system if an error occurred during item conversion.
Converted By Shows the ID of the user who had the item converted.
Converted On/At Shows the time and date when the item was converted.
Error Text Specify the text that will be shown if the conversion failed.

You can enter a maximum of 250 characters in this field.

Lines#

Field Description
Field Source Specify the source of the field to be converted. Options are Item Base Data or Add. Item Field.
Field ID Specify the unique key of the item to be converted. Depending on the Field Source, it is a value taken from table 27 (Item) or the code of an additional field retrieved from table 71076604 (Additional Field Base Data).

The No. field in the item table must not be selected here. You see an error message if it is.
Field Caption Shows the caption of the field selected via the Field Source and Field ID.
Field Type Shows the type of the field selected via the Source Field and Field ID.
Field Length Shows the length of the field selected via the Source Field and Field ID.
New MDR Field Value Specify the new value that should be assigned to the selected field during conversion.

If the field is of type Option (but does not depend on another field value) or Boolean, you can drill down to choose a value. You can do the same if the selected table references another, which means that the value will be taken from there.

You are notified if you specify a value that cannot be used right now and can choose whether to enter another.

This way, you can set values that might not be valid at present but will be at the time the item should be converted, for example, due to a change in setup.
Old MDD Field Value Shows the old field value from the master record.

Conversion process#

An item is only converted if the conversion date specified for it is the same as or earlier than the work date.

You can convert items by running the relevant function from the ribbon or have them converted automatically by adding the task to the job queue. If you convert manually, you can set a filter on the Item No. field.

If the conversion is carried out by the NAS via the job queue, a dialog box isn’t shown and all certified items are converted at once.

Manual#

To start conversion manually:

  1. Choose the Search icon, enter Convert MDR Item from MDD, and then choose the related link.
  2. Use the Assist button next to the Item No. field to select an item from the list.

Note

Only conversions in the Certified status can be seen on the list. Additionally, the conversion date cannot be later than the work date.

You can set any type of filter value in the Item No. field, including <>ITEM_0422, >A and ITEM_0422|ITEM _0509. In the latter example, ITEM_0422 and ITEM _0509 will be converted. If the Item No. field on the request page is left blank, every item in the Certified status and with a conversion date smaller than or equal to the current date will be converted.

If you specify an item number that is stored in the system but that isn’t certified, that includes a later conversion date, or that no record exists for in conversion setup, you see an error message and the process is canceled.

At the time of certification, no Old MDD Field Value exists on the lines, as the field is filled in during conversion with a value from the item card.

When you choose OK to start the conversion, you’re asked to confirm your choice. If you don’t choose OK again here, the process will be canceled altogether.

If conversion fails, the conversion status is automatically set to Error. You then see a message in the Error Text field. In the same vein, you’re also notified if conversion is successful, with the status set to Converted and the Converted By and Converted On/At fields filled in. The old MDD field values are also entered on the lines and a message appears, stating how many items have been converted.

The new values can then be found on the item card according to conversion setup.

Job Queue#

For values that you want converted automatically with the help of the job queue, you must set up an entry in the queue for codeunit 71076791 (MDR Job Queue Handler) with the ‘convert mdd to mdr’ string.

When the queue is run, the system then converts all certified records that include a conversion date on or before the work date. If the process is successful, the values on the conversion cards are updated in the same way as during manual conversion.

If processing encounters an error, the status of the conversion record is set to Error and the Error Text field is filled in. The system then continues with the next item that needs to be converted.

Item#

You can use the Check Approval Reqs. Field, found on the Misc. FastTab in the item master, to specify whether the system should check for approval requirements in an MDR context (where they’re called ‘authorizations’).

Option Description
No No check is run.
Sales Verifies approval requirements on sales documents only.
Purchasing Verifies approval requirements on purchase documents only.
Sales & Purchasing Verifies approval requirements on sales and purchase documents.

medtec365 Setup#

To set up DMS integration for MDR documents:

  1. Choose the Search icon, enter medtec365 Setup, and then choose the related link.
  2. On the DMS Integration FastTab, fill in the fields as described in the following table.
Field Description
DMS Document Nos. Specify the series that will be used to assign numbers to MDR documents.
DMS Sales/Purch. Doc. Check Specify when approval requirements should be checked on sales or purchase lines and when MDR document entries should be created.

An MDR document that is linked to a header in the system is always created during the release of an internal document, without approval requirements being checked.

Release
Approval requirements are checked and entries are created after the relevant document is released.

New Line
Approval requirements are checked and entries are created on filling in a line on the relevant document, that is, when the system validates the item number, variant code, and the warehouse shipment date (for a sale) or expected receipt date (for a purchase) on the new line.
Use Document Viewer Turn on this toggle if you want to see MDR documents on sales and purchase documents.
Field Name (MDR Link) Specify the field that will be used for linking the DMS to Microsoft Dynamics 365 Business Central1.

MDR DMS Structure Setup#

Here you can specify the areas, groups, and names required for the structure of the DMS. To specify the structure:

  1. Choose the Search icon, enter MDR DMS Structure Setup, and then choose the related link.
  2. Fill in the fields as described in the following table.
Field Description
Type Specify the type of the structural element (area, group, or name).
Code Specify a code for the structural element. The code must be unique.
Description Specify a description for the structural element.
Approval Reqs. Specify the approval requirements for elements of the Name type.

MDR DMS Document Types#

On this page, you can specify the document types that will be used in the DMS.

  1. Choose the Search icon, enter MDR DMS Document Types, and then choose the related link.
  2. On the ribbon, choose New.
  3. Fill in the fields as described in the following table.
Field Description
Code Specify a code for the document type.

If the type is later renamed via a code change, the system will update the field with the same name on every MDR document and document assignment page automatically.
Description Specify a description for the document type.
Status Specify the status of the document type. Only records in the Certified status can be used for the DMS.

New
Set when the record is created. You can change the type in this status.

Certified
Set so that the document type can be used on a DMS document. You cannot change the record in this status.

In Progress
Set to reopen a certified document type.

Expired
Set so that the current record cannot be used or edited.
Area Choose an area from DMS structure setup.
Group Choose a group from DMS structure setup.
Name Specify the name of a DMS structure.
Renewal Date Formula Specify the date formula that will be used to calculate the value in the Renewed On field when the Valid To field is validated on DMS documents.

You see an error message if the date calculated based on the formula is not in the past, that is, if it does not start with a minus sign (-).
Paper Size Specify what paper size to use for printouts (A3 or A4).
Print Orientation Specify the orientation of printouts (Portrait or Landscape).
Created By Filled in with the ID of the user who created the record.

You cannot change this field manually.
Created On/At Filled in with the date and time when the record was created.

You cannot change this field manually.
Modified By Filled in with the ID of the user who edited the record.

You cannot change this field manually.
Modified On/At Filled in with the date and time when the record was edited.

You cannot change this field manually.

MDR DMS Document Control#

Here you can specify the conditions that must be met for the system to create the entries that link Microsoft Dynamics 365 Business Central1 to MDR documents.

  1. Choose the Search icon, enter MDR DMS Document Control, and then choose the related link.
  2. On the ribbon, choose New.
  3. Fill in the fields as described in the following table.
Field Description
Document Required Specify if approval requirements should be checked on the selected document line.

The check is run if the line relates to a sales or purchase document and the Check Approval Reqs. field for the item on the line is set to Sales, Purchasing, or Sales & Purchasing.

The check is successful if the system finds a valid MDR document with a document type where the Name field value corresponds to the approval requirements specified in MDR DMS Structure Setup.
Print Document Select this field if you want the associated MDR document printed together with the main document as supporting documentation on the Print Portal.

The setting is retrieved from the relevant print configuration when a document entry is created and is later copied to entries that you create for follow-on documents.
Values Inherited Specify if the source document will be used to create MDR entries when follow-on documents are set up, for example, when you:

• Post a sales document that includes a shipment.
• Post a sales document that an invoice was created for.
• Post a purchase document that shows a receipt.
• Post a purchase document that an invoice was created for.
• Post a journal on which order type Production and an order number was specified.

• Post an assembly order.
Document Type Specify the type of the document.
Error Level (Doc. Required) Specify what you want to see happen if the approval requirements check fails.

(blank)
No action will be taken.

Log
A log entry will be created in the background, but you can continue with the transaction you started.

Warning
You see a warning message, but you can continue with what you were doing by choosing OK in the dialog box.

Error
You see an error message and the process will be canceled.
Status Shows the status of document control.

New
Set by the system when a record is created.

Certified
Set via the status actions on the ribbon. Only certified records are used by the DMS. They cannot be edited, however.

In Progress
Set via the status actions on the ribbon. Allows to reopen certified and expired records.

Expired
Set via the status actions on the ribbon. Records that are no longer valid cannot be changed and are not included in the DMS.
Item No. Specify the number of an item.
Variant Code Specify the code of a variant, if available.
Item Version Code (As version codes have not yet been added to document lines, this field cannot currently be edited.)
Country/Region Code Fill in a country or region.
Customer No. Specify the number of a customer.
Vendor No. Specify the number of a vendor.
Documents#

On this FastTab, you can turn on one or more of the following toggles to specify the types of documents that document control should apply to:

  • Sales Quotes
  • Sales Orders
  • Blanket Sales Orders
  • Sales Invoices
  • Posted Shipments
  • Posted Sales Invoices
  • Purch. Quotes
  • Purch. Orders
  • Blanket Purch. Orders
  • Purch. Invoices
  • Prod. Orders
  • Subcontract Orders
  • Assembly Orders
  • Repairs

Alternatively, you can use the Select All action on the Options FastTab to turn on the toggles for all documents listed. Select None will cancel the current selection.

Document Type Details#

This FastTab shows the description, area, group, and name of a document type. For more information, use the lookups available for the fields on the tab.

MDR DMS Document List#

To see the list of current MDR DMS documents or create a new document:

  1. Choose the Search icon, enter MDR DMS Document List, and then choose the related link.
  2. To create a new document, choose New on the ribbon and fill in the fields as described in the following table.
General#
Field Description
No. This field is filled in automatically with a number from the series set up for MDR documents.
Document Type Specify the type of the MDR DMS document.

Filling in this field also fills in the description of the document type, the area, the group, the name, and the approval requirements.
Description
Description 2
These fields can be used to describe the document.
Status When the document is created, this field is automatically set to New.

You can change the status of the record manually. Documents in the New status will not be used in the DMS, and you can only change the status by running one of the actions mentioned earlier.

Additionally, certified or expired documents cannot be deleted from the system.
External Reference Specify an external reference, if available.
Bar Code Shows the bar code that will be used for the Reserve Bar Code action.

You cannot change this field manually.
Valid From Specify the date when the document becomes valid.

If you decide to move up the date later, when assignment lines exist, the system will check whether an earlier date was entered on one of the lines of the MDR document. If so, you will see an error message.
Valid To Specify until when the document should be valid.

If you decide to move up the date later, when assignment lines exist, the system will check whether a later date was specified on a line of the MDR document. If so, you will see an error message.

After you filled in this field, the system will calculate the value in the Renewed On field based on the formula specified for the document type.

You can change this field manually, if necessary. You see a message when you change it after the Renewed On field has been filled in.
Renewed On This field is filled in automatically when you fill in the Valid To field but can be changed manually, if necessary.
Renewed This field shows if a document entry exists for MDR DMS document renewal in status New or Requested.
Document Type Descr. The value of this field is taken from the Description field of the MDR DMS document type after the type has been entered.

You can use a lookup to see the related document type record.
Area Shows the area assigned to the MDR DMS document type after the Document Type field has been filled in.

You can drill down into the field to get to MDR DMS Structure Setup.
Group Shows the group assigned to the MDR DMS document type after the Document Type field has been filled in.

You can drill down into the field to get to MDR DMS Structure Setup.
Name Shows the name assigned to the MDR DMS document type after the Document Type field has been filled in.

You can drill down into the field to get to MDR DMS Structure Setup.
Paper Size Specify what paper size to use for printouts (A3 or A4).
Print Orientation Specify the orientation of printouts (Portrait and Landscape).
Approval Reqs. Shows if approval requirements exist.

The setting in this field is retrieved from MDR DMS Structure Setup.
Created By Filled in with the ID of the user who created the record.

You cannot change this field manually.
Created On/At Filled in with the date and time when the record was created.

You cannot change this field manually.
Modified By Filled in with the ID of the user who edited the record.

You cannot change this field manually.
Modified On/At Filled in with the date and time when the record was edited.

You cannot change this field manually.
Assignment#
Field Description
DMS Document No. This field is filled in automatically with the number of the assigned document.
Status Specifies the status of the document assignment.

New
Set by the system when a new record is created.

Certified
Can be set manually so that the item is included in the DMS. A certified assignment cannot be edited.

You see an error message if you try to select the status without having filled in the Valid From and Valid To fields.

In Progress
Can be set manually so that you can reopen a certified record for editing.

Expired
Cannot be edited and is not used by the DMS.
Item No. Specify the item that needs to be available on a document line for the assignment to apply.

With the field left blank, the document is only assigned to headers.

You see an error message if you try to enter an item that compliance checks still need to be run on or for which data maintenance has been completed and the item has been released.
Variant Code Specify the variant that needs to be available on a document line for the assignment to apply.

With this field and the previous field left blank, the document is only assigned to headers.
Item Version Code Specify the item version code that needs to be available on a document line for the assignment to apply.

Note
The field cannot be changed at present, as the item version code requirement has not been implemented yet.
Country/Region Code Specify the country code that needs to be available on a document line for the assignment to apply.
Customer No. Specify the customer who needs to be available on a document line for the assignment to apply.

You see an error message if you try to enter a customer number that compliance checks still need to be run on or for which data maintenance has been completed and the number released.
Vendor No. Specify the vendor who needs to be available on a document line for the assignment to apply.

You see an error message if you try to enter a vendor number that compliance checks still need to be run on or for which data maintenance has been completed and the number released.
Valid From Specify the date from when the assignment should be valid.

You see an error message if you fill in this field with a date that is earlier than the date specified in the Valid From field on the DMS document header.
Valid To Specify the date until when the assignment should be valid.

You see an error message if you fill in this field with a date that is later than the date specified in the Valid From field on the DMS document header.
Created By Filled in with the ID of the user who created the record.

You cannot change this field manually.
Created On/At Filled in with the date and time when the record was created.

You cannot change this field manually.
Modified By Filled in with the ID of the user who edited the record.

You cannot change this field manually.
Modified On/At Filled in with the date and time when the record was edited.

You cannot change this field manually.
Home: Ribbon Functions#

Set to Certified

Sets the document to Certified. Only certified records are included in the DMS but cannot be edited (except for their assignment lines) and cannot be deleted.

With the status set to Certified, the compliance process for MDR documents will be started after you enter a compliance message (provided the functionality is set up).

You will also see an error message if the date entered in the Valid To field is earlier than the work date and certification will be canceled.

Note

To be able to use this feature, you need a license for the Compliance functionality.

Set to In Progress
Sets the status of the document to In Progress.

Documents in progress can be edited but aren’t used for document control.

Set to Expired

Sets the status of the document to Expired.

Expired documents cannot be edited (except for their assignment lines). Additionally, they aren’t included in the DMS and cannot be deleted either.

Copy Document

Copies selected data to a new DMS document, with an option to include assignment lines and comments.

Comments

Used to enter comments about the document.

Reserve Bar Code

Reserves a bar code for the document.

Factboxes#

ELO

Can be used to drag and drop an MDR document into, to see the information stored on the document.

Compliance status

Shows the compliance status and history.

Note

To be able to use this feature, you need a license for the Compliance functionality.

MDR documents: compliance#

When you set up the Compliance functionality, you can also choose Table 71076686 (MDR DMS Document) as a compliance tables.

Table 71076684 (MDR DMS Document Assignment) has been added as a subtable.

Note

You need a separate license before you can use this feature.

Job queue: compliance#

If you want document renewals checked and created automatically with the help of the job queue, you must set up an entry in the queue for codeunit 71076791 (MDR Job Queue Handler) with the ‘check renewals’ string.

Lists#

MDR assignments#

MDR assignment lines can be displayed without filters or filtered by item, customer, or vendor.

To see all links available in the system, choose the Search icon, enter MDR DMS Doc. Assignment List, and then choose the related link. The fields on the page correspond to those on the Assignments FastTab of MDR DMS document cards.

Alternatively, open an item card, a customer card, or a vendor card, and then choose Actions > MDR > MDR Assignments on the ribbon to see the links filtered by type of base data.

Document entries#

To see a list of all MDR document entries, choose the Search icon, enter MDR DMS Document Entries, and then choose the related link. See the following table for a more detailed description of some of the fields that you can find on the page. For an explanation of the other fields, see MDR DMS Document List and MDR DMS Document Control.

Field Description
Entry No. Shows the unique number of the document entry.
Entry Type Specifies the process that the entry was created for.
Source Type Shows the ID of the table that the entry is assigned to. The assignment is determined based on this and the Source Subtype, Source ID, and Source Ref. No. field.
Source Subtype For entries of source type 36 (Sales Header), 37 (Sales Line), 38 (Purchase Header), and 39 (Purchase Line), shows the number of the document type option as specified in the table that is assigned to the entry. Entries linked to other source types have a value of 0 in this field.
Source ID Shows the number of the document that the entry is assigned to.
Source Ref. No. Shows the number of the document line that the entry is assigned to.

Entries linked to document headers have a value of 0 in this field.
Record ID Contains all the key field values from the document header that the entry is assigned to.

This means that the key values stored on the document header can also be found on the entries assigned to the document lines.
Source Event Shows the event that led to the creation of the entry.

Log#

You can use the general search function to open the MDR Log page.

Workflow#

Overview#

Throughout this section, a variety of examples will be used to describe the process of document control, covering the review and renewal of MDR documents and their assignment to one of the following records in the system:

Sales Purchasing Miscellaneous
Quotes Quotes Production orders
Orders Orders Subcontract purchase orders
Blanket orders Blanket orders Assembly orders
Invoices Invoices Repairs
Posted shipments
Posted invoices

Note

The difference between purchase orders and subcontract purchase orders is that the Prod. Order No. field is filled in on the lines of the latter.

Repairs, on the other hand, are represented by one or more service lines on which the CSR Case No. field is filled in with a repair-related case.

Find DMS documents#

As a first step to finding MDR DMS documents related to a document header in the app or a document line on which a certain item was specified, the system searches document control for records that meet the following criteria:

Criterion A

  1. For a sale
    The Customer No. field in the record is blank or the number in the field is the same as the sell-to customer number on the sales document.
  2. For a purchase
    The Vendor No. field in the record is blank or the number in the field is the same as the buy-from vendor number on the purchase document.
  3. For production or assembly
    Customer and vendor numbers aren’t available.

Criterion B

  1. For a sale
    The Country/Region Code field in the record is blank or the code is the same as the ship-to country/region code on the sales document.
  2. For a purchase
    The Country/Region Code field in the record is blank or the code is the same as the buy-from country/region code on the purchase document.
  3. For production or assembly
    A country/region code isn’t available.

Criterion C
The status of the document control record is set to Certified.

Criterion D
The Item No. field in document control is blank (for a header) or the number in the field matches the item number entered on the standard document line.

Criterion E

The Item Version Code field in document control is blank (for a header).

As version codes haven’t been implemented yet on document lines, this criterion is always fulfilled at line level.

Criterion F

The Variant Code field in document control is blank (for a header) or the code in the field matches the variant code entered on the standard document line.

Criterion G

The type of the associated document (such as Sales Order or Purchase Order) has been selected in document control.

As a next step, the system checks each DMS document linked to the records it finds for an assignment line that fulfils the following conditions:

Condition 1

The document type set for DMS assignment matches the type selected in document control.

Condition 2

  1. For a sale
    The Customer No. field on the assignment line is blank or the number in the field is the same as the sell-to customer number on the sales document.
  2. For a purchase
    The Vendor No. field on the assignment line is blank or the number in the field is the same as the buy-from vendor number on the purchase document.
  3. For production or assembly
    Customer and vendor numbers aren’t available.

Condition 3

  1. For a sale
    The Country/Region Code field on the assignment line is blank or the code is the same as the ship-to country/region code on the sales document.
  2. For a purchase
    The Country/Region Code field on the assignment line is blank or the code is the same as the buy-from country/region code on the purchase document.
  3. For production or assembly
    A country/region code isn’t available.

Condition 4
The status of the assignment line is set to Certified.

Condition 5
The Item No. field on the assignment line is blank (for a header) or the number in the field matches the item number on the standard document line.

Condition 6
The Item Version Code field on the assignment line is blank (for a header).

As version codes haven’t been implemented yet on document lines, this condition is always fulfilled at line level.

Condition 7
The Variant Code field on the assignment line is blank (for a header) or the code in the field matches the variant code on the standard document line.

Condition 8

The Relevant Document Date is in the period specified by the Valid From and Valid To fields on the assignment line.

For Date options
Sales header Order Date or Posting Date
Sales line Shipment Date or Work Date (the latter if approval requirements need to be checked prior to posting)
Purchase header Order Date or Posting Date
Purchase line Expected Receipt Date or Work Date (the latter if approval requirements need to be checked prior to posting)
Production order header Due Date
Production order line Due Date
Item journal line of order type Production Posting Date
Assembly header Due Date or Posting Date
Assembly line Due Date

An assignment line found in this way then shows in the DMS Document No. field the MDR records linked to a standard document header or line in the app.

Meet approval requirements#

An approval requirements check is performed on a sales or purchase document line if the Check Approval Reqs. field for the item specified on the line was set to Sales or Sales & Purchasing (for selling the item) or to Purchasing or Sales & Purchasing (for buying it). This check succeeds if:

  • The line is linked to a valid document control record that the Document Required field was selected for.
  • The MDR document found with the help of document control and DMS assignment is of a document type that the Approval Reqs. field was selected for in the Name part of MDR DMS Structure Setup.

Copy documents#

You can also create an MDR document from an existing document:

  1. Open an MDR document.
  2. On the ribbon, choose Copy Document.
  3. Fill in the fields on the request page as described in the following table.
Field Description
Copy Links Specify if you want to copy the assignment lines set up for the document.

This toggle is turned on by default.
Copy Comments Specify if you want to copy the comments stored for the document.

This toggle is turned off by default.
New Validity Date (Formula) Enter the formula that you want the system to use to calculate the Valid From and Valid To dates (as well as the renewal date) on the MDR document and the assignment lines.

If the field is left blank, the old validity field values will be kept.

The status of the MDR document and the assignment lines is set to New when you run this function.

Check for required documents#

If an approval requirements check is run (see Meet Approval Requirements) and the check fails, the system takes measures to remedy the situation.

What these measures look like depends on the option that you selected in the Error Level (Doc. Required) field in document control.

The check is also performed before a document is posted, the only difference being that if you set the error level to Warning in this context, you will not be notified when a process doesn’t pass the check—so that you will not be inundated with messages when posting more than one document at once.

No MDR document entries will be created during the check.

Error levels#

In all examples found in this subsection, an approval requirements check is run for an item that you want to enter on sales documents. However, before you can enter the item, the Check Approval Reqs. field on the associated item card must be set to Sales (or Sales & Purchasing).

Log Level#

On the Log level, an entry is made in the MDR log, and you see a message describing the error that occurred during the check but can continue with the transaction.

Example
You certify a document control record. This record includes a document requirement for sales orders on which the item referenced at the beginning of the section is filled in and document type DRAWING is selected. Afterward, you set the error level to Log. A certified document assignment doesn’t exist.

When you create and release an order on which the item is entered, the order is then recorded in the MDR log, but you will not be informed about any requirements check.

Warning Level#

On this level, you see a message, and an entry is made on the MDR document. After you’ve confirmed seeing the note, you can continue, however.

If you had selected this option in the example situation described earlier, you would now see a message on trying to release the order, telling you about the missing approval requirements.

By choosing OK in the dialog box, you would nevertheless be able to release it while the system would create a log entry for it.

Exit Level#

With the level set to Error, the system shows an error message before canceling the transaction altogether.

Choosing this option in the previous example would show a message describing the error if an attempt were made to release the order, and the order would remain open after confirming the note. A log entry wouldn’t be created.

You can use the Print Document field on the MDR DMS Document Control to specify how you want the system to print MDR documents. Two different approaches can be used. MDR printouts can be added as supporting documents (for example, when you want to sell an item) or by running an action (such as on production orders).

Example
You certify a document control record that includes print settings used for sales and production orders of document type DRAWING.

Afterward, you certify an MDR document that is stored in the DMS (see ELO FactBox) and that is assigned to the item mentioned earlier.

As a result, the MDR document will consist of a text that reads DRAWING.

As Supporting Documentation#

If you want MDR documents printed in the form of supporting documentation, the system searches all DMS document entries referencing the selected document in the app for entries where the Print Document field has been selected.

As an example, you create and release a sales order on which a line is linked to an MDR document with the help of a document entry (which you can see by using the Show MDR Doc. Entries action on the ribbon).

Among other things, this entry shows the standard document header in the Record ID or the relevant line in the Source Ref. No. field, as well as the number of the MDR record and the item number (if available). The Source Event field, on the other hand, specifies the event that led to the creation of the entry, and the Print Document field if the DMS record should be printed as supporting documentation.

When you run the Print Confirmation function on the order, the linked MDR document is then printed together with the confirmation note.

Through use of a function#

As an example, you assign four MDR documents to a production order (one to the header and three to the lines) for when the Refresh Production Order action is run; you can view them by using the Show/Print MDR Docs. function on the ribbon.

Unlike on sales orders, printouts of supporting documentation aren’t available here. Instead, you choose Show/Print MDR Docs. to open or save an MDR record (or exit the dialog box) or Open to view the documents in your default PDF reader and print them there as well.

Prevent more printouts#

Only one MDR document entry can be assigned to each header or line in the system, although more than one can be assigned to the same standard document (that is, to the header and multiple lines). This is to ensure that every MDR document is printed only once. The MDR document entries remain unchanged during this process.

Example
You store the following certified document control records in the system:

Document Type Print Document /
Values Inherited
Item No. Sales Order
SALES-QUO Yes Yes
SALES-QUO Yes ITM01 Yes
SALES-QUO Yes ITM02 Yes
DRAWING Yes ITM01 Yes
DRAWING Yes ITM02 Yes
COMPATIBILITY Yes ITM01 Yes
COMPATIBILITY Yes ITM02 Yes

Additionally, you make the following MDR assignments for the document types:

Document Type DMS Document No. Item No. Country/Region Code Customer No.
SALES-QUO MDR-28 DE
SALES-QUO MDR-28 CUST01
DRAWING MDR-18 ITM01 DE
DRAWING MDR-18 ITM01 CUST01
SALES-QUO MDR-18 ITM01
COMPATIBILITY MDR-38 ITM01 CUST01
COMPATIBILITY MDR-38 ITM01 DE
DRAWING MDR-18 ITM02 DE CUST01
DRAWING MDR-18 ITM02
SALES-QUO MDR-28 ITM02
COMPATIBILITY MDR-38 ITM02 DE
COMPATIBILITY MDR-38 ITM02 CUST01

For CUST01, you also create and release a sales order that includes two lines where ITM01 and ITM02 have been entered.

When you simulate the creation of MDR document entries for order headers (which no item numbers are entered for), customer CUST01, and country code DE, you then see that two valid document assignments exist for MDR document MDR-28.

Simulating the creation of entries for all order lines with item 01, CUST 01, and DE will get you five valid assignments (one for MDR-28 and two each for MDR-18 and MDR-38).

Performing the simulation for lines with ITM02, CUST01, and DE will also result in five assignments (one for MDR-28, two for MDR-18, and two for MDR-38).

When you release the order, an MDR document entry will be created from each valid DMS assignment simulated for a standard document header (Source Ref. No.= 0) or line (Source Ref. No.= Line No.).

However, the system will prevent entries from being assigned more than once to the same MDR header or line. For example, it will create a single entry from the two valid header assignments for MDR-28 (but all entries for the lines).

When you print the confirmation document as described in an earlier example, each MDR document header and line assigned to an MDR document entry will be printed once, although the confirmation will end up on the first page. This means that MDR-28 (type SALES-QUO) will be printed on page 2, MDR-18 (DRAWING) on page 3 of 4, and MDR-38 (COMPATIBILITY) on the last page.

Inheritance#

Inheritance of DMS information mainly occurs when you post or archive records in the system. Whether document information will be inherited can be specified in the Values Inherited checkbox in document control.

When you post sales or purchase documents or assembly orders for which the field has been selected, their links to MDR documents are copied to the records that you create from them (such as posted shipments, receipts, or invoices).

On production orders, information is inherited when you post journal lines on which the order type Production Order, a production order number, and a production order line number have been specified.

When you archive sales or purchase documents (quotes, orders, and blanket orders), MDR documents will also be copied to the relevant document archives.

Post an assembly order#

As an example, you create and release an assembly order. Two MDR documents are found for it, with one each assigned to the order header and a line. You then pick and post the order so that the MDR documents are linked to the posted record as well.

Afterward, you can choose Show MDR Doc. Entries or Show/Print MDR Docs. on the ribbon to either view the MDR entries set up for the posted document or to view and print the assigned MDR documents.

When you run the Show MDR Doc. Entries action, the entries linked to the document header and lines set up in the app will be displayed in list form, with the Source Ref. No. field showing the line number from the internal document. If the value in the field is 0, the MDR entry has been assigned to the header.

If a document entry is created for a tracked item (that is, an item with a serial or a lot number), the document count on the MDR DMS Entry Hierarchies page is set up and updated in reference to not only the standard document line but also a serial number (source type 6504) or a lot number (source type 6505).

As a result, you can see in the MDR Documents FactBox on the relevant serial or lot number information card how many DMS records have been assigned to it via MDR document entries.

Archive a quote#

As another example, you create and release a sales quote that includes two lines with items on them and have seven document entries created for the header and lines of the document.

Afterward, you use the Archive Document action on the ribbon to archive the quote as version 3 and run the Show MDR Doc. Entries action to have the MDR document entries copied to the archived quote—except for the Source Type and Source Event values, which are updated instead.

Running the Show/Print MDR Docs. function then shows you the MDR documents assigned to the document entries (SALES-QUO MDR-28, COMPATIBILITY MDR-38, and DRAWING MDR-18).

Renewals#

With this feature, you can log rejections of MDR documents that are about to expire, as well as requests for and receipts of new documents.

When you open the MDR DMS Document Renewals page, it is filtered for documents in the New/Requested status. You can change the filter via drill down so that you can see what renewals you have or haven’t received.

The MDR DMS Assignments FastTab, on the other hand, shows the assignment lines available for the currently selected MDR document.

See the following tables for an explanation of individual tab fields.

Filters#
Field Description
Status Used to show the status of document renewals. Options are:

• New/Requested
• Received/Not Rcvd.
MDR DMS Assignments#
Field Description
Entry No. Shows the number of the record.

You cannot change this field manually.
For New Doc. Specifies if a copy should be created for the current document when you run the Create Documents action (see Create MDR Documents).
Document No. Specifies the number of the MDR document that a new version has been requested for.

You cannot change this field manually.
Document Type Specifies the type of the MDR document.

You cannot change this field manually.
Status See Filters.
Requested By Specifies the ID of the user who requested a new MDR document.
Requested On Specifies when a new MDR document was requested.
Received On Specifies when a new document was received.
Checked By Specifies the ID of the user who checked the renewal information.

This entry must be filled in for the status to be set to Received or Not Rcvd.
New Document No. Specifies the number of the new MDR document.
Reason Not Rcvd. Specifies why no new MDR document has been received (yet).
New Valid From Specifies the Valid From date entered on the new MDR document and the new approval requirement lines.
New Valid To Specifies the Valid To date entered on the new MDR document and the new approval requirement lines.
Created By Shows the ID of the user who created the record.

You cannot change this field manually.
Created On/At Shows when the record was created.

You cannot change this field manually.
Modified By Shows the ID of the user who last changed the record.

You cannot change this field manually.
Modified On/At Shows when the record was last changed.

You cannot change this field manually.
Document Type Descr. Shows the description of the associated document type.

You cannot change this field manually.
Area Filled in with the area specified for the associated document type.
Group Filled in with the group specified for the associated document type.
Name Filled in with the name specified for the associated document type.
DMS Document Descr. Shows the description entered on the related MDR document.
DMS Doc. Valid From Shows the Valid From date entered on the related MDR document.
DMS Doc. Valid To Shows the Valid To date entered on the related MDR document.
DMS Doc. External Ref. Shows the external reference entered on the related MDR document.
Create a renewal#

You can create document renewals in two ways, namely by running the Check MDR DMS Renewal function or adding document renewal to the job queue.

If you use the ribbon function, you need to choose OK in the dialog box that appears before renewals can be checked. The system then searches for all MDR documents that meet the following conditions:

  1. The Renewed On field is filled in.
  2. The date in the Renewed On field is earlier than or equal to the work date.
  3. The Renewed checkbox isn’t selected.

Afterward, a renewal is created for each document found, and the Renewed field on the document is selected automatically.

Change a status#

On the lines, you can change the renewal status from New to Requested, Received, or Not Rcvd. Depending on the status selected, the system checks which fields must be filled in on a line, as described in the following table.

New status Mandatory fields
Requested Requested By
Requested On
Received Received On
Checked By
New Document No.
New Valid From
New Valid To
Not Rcvd. Checked By
Reason Not Rcvd.

You see an error message if you try to change the status field although one or more mandatory fields haven’t been filled in yet. The message is updated when you enter the missing values.

When all required fields are filled in and the status of the line is set to Received, you must set the Status Filter field to Received/Not Rcvd. if you still want to see the line.

Changing the status clears the Renewed checkbox. To prevent another renewal from being created, the Renewed On checkbox is emptied as well.

When you change to Not Rcvd., you need to decide whether to delete the current MDR document from monitoring. Only if you choose Yes will the renewal date be deleted from the document so that no other renewal is created.

You can no longer change a renewal record that is set to Received or Not Rcvd.

Create MDR Documents#

For each renewal that you receive, you can create a new MDR document from the old one by running the Create Documents action on the ribbon.

When you run the function, the status fields on the new document are set to New and the New Valid From and New Valid To dates specified for the renewal are copied to it as well. The other field values are transferred from the old document.

New MDR documents can be created for all renewal lines on which the For New Doc. field is selected. To be able to select a line, the following conditions must be fulfilled on it:

  1. The New Document No. field must be blank.
  2. The Received On field must be filled in.
  3. The Checked By field must be filled in.
  4. The New Valid From field must be filled in.
  5. The New Valid To field must be filled in.

You cannot select a line that doesn’t meet these conditions.

Afterward, you can run the Create Documents action for the selected lines and specify whether you want to copy the comments stored for the old documents.

You see a message when the process is complete. The number of new documents is then entered on the renewal record.

Document compliance#

If MDR document control is integrated into your company’s compliance procedures, the compliance process is started when an attempt is made to change the status of an MDR document to Certified.

You must then enter a compliance text. Afterward, you’re notified that the document cannot be certified until completion of the approval process, which is described here.

Note

To be able to use this feature, you need a license for the Compliance functionality.

Simulate document entry creation#

On the Simulated MDR DMS Entries page, you can simulate the creation of document entries to check your current document control configuration.

After you run the simulation, you will see the entries that could be created according to current setup on the Simulated DMS Document Entries FastTab.

Setup#

To specify filters and documents for the simulation, you must first select a simulated event.

What documents you can select depends on the Customer and Vendor No. fields. If both are blank, you can select only documents from the Miscellaneous category here (production, subcontract, assembly, or repair orders; see Overview), as you need customer numbers for sales and vendor numbers for purchase documents.

Field Description
Simulated Event Specifies the event to be simulated.

If the event that you enter here is different from the event specified in the DMS Sales/Purch. Doc. Check field (see medtec365 Setup), the system will not create MDR entries for sales and purchase document lines.

Options are leaving the field blank (no simulation possible), Release, and New Line.
Perform Simulation When you run this action, the selected filters and documents will be used to simulate the specified event and the subsequent creation of document entries.
Filters#

On this FastTab, you can specify the field values that should be used to simulate the creation of MDR document entries on release of a document or document line in the app or the addition of a new standard document line.

If you don’t fill in the Item No. field on the tab, the system will simulate entry creation for document headers.

Field Description
Customer No. Specify the number of the sell-to customer that should appear on the document.
Vendor No. Specify the number of the buy-from vendor that should appear on the document.
Country/Region Code Enter a sell-to or buy-from country code, depending on what type of transaction you want to simulate.
Item No. Specify the number of an item that should appear on the document line.
Variant Code Specify the item variant that should appear on the document line, if necessary.
Relevant Document Date The work date is entered in this field automatically as the date for assessing MDR document validity.

You can change the date, if needed, but the field must not be left blank.

What document or document line date can be entered is listed in an earlier section of this article (see Relevant Document Dates).
Apply Simulated Values to Document Selection#
Function or Field Description
Select All Selects all documents that can be edited.
Select None Removes the selection from all documents.
Sales Quotes
Sales Orders
Blanket Sales Orders
Sales Invoices
Purch. Quotes
Purch. Orders
Blanket Purch. Orders
Purch. Invoices
Production Orders
Subcontract Purch. Orders
Assembly Orders
Repairs With the relevant toggle turned on, simulates the creation of MDR document entries for this document type.
Simulated MDR DMS Entries#
Field Description
DMS Doc. Link Line No. Specifies the line number of the MDR DMS document assignment that will be used as a basis to simulate the creation of the current document entry.

Clicking the field value will open a filtered version of the MDR DMS Document Links page.
DMS Document No. Specifies the entry number of the MDR DMS control record that will be used as a basis to simulate the creation of the current document entry.

Clicking the field value will open a filtered version of the MDR DMS Document Links page.

For an explanation of the other fields on this FastTab, see Document Entries.

Workflow#

As an example, you select Release as the event to simulate and a production order document thereafter. You don’t fill in an item number so that the simulation applies to document headers in the app.

After you run the simulation, the entries that could be created for MDR records MDR-28 and MDR-33 are shown on the Simulated MDR DMS Entries FastTab. The number of simulated entries is shown as a heading.

You then use the lookup on the Entry No. (Doc. Control) field. You see that document type SALES-QUO has been assigned to the production order header on the document control record found for the simulated field values.

Afterward you use the lookup on the DMS Doc. Link Line No. field. This time, you see document MDR-28 linked to type SALES-QUO on the related MDR assignment record.

With the next lookup on the DMS Doc. Link Line No. field, you see document MDR-33 is also assigned to document type SALES-QUO.

Now you rerun the simulation with ITM02 entered in the Item No. filter field. You see that a document entry was created for MDR document MDR-18.

In summary, the simulations show that when a line containing ITM02 and a due date of 08/31/2024 (Relevant Document Dates) is released as part of a production order, MDR documents MDR-28 and MDR-33 would be created for the header and another MDR document, MDR-18, for a line.

If the MDR documents determined in this way do not match your expectations, you need to adjust the setup.


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