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Regulated Products

Overview

Many businesses have the need to manage some level of product or inventory compliance in conjunction with various regulations or requirements. 

Regulated products are items that are subject to specific government regulations, industry standards, or safety requirements. These regulations can vary by location and industry. Regulated products often require strict adherence to guidelines and standards to ensure safety, quality, and compliance.

Examples of regulated products might include:

  • Pharmaceuticals and medical devices, subject to strict healthcare regulations.
  • Chemicals and hazardous materials, governed by environmental and safety regulations.
  • Food and beverages, requiring compliance with food safety and labeling regulations.

Dynamics 365 Supply Chain Management provides tools for managing and tracking regulated products to ensure compliance, safety, and accurate reporting. This includes features for maintaining regulatory documentation, tracking product certifications, and managing compliance throughout the supply chain.

In conjunction with regulation, a product can be marked as a reported product which typically denotes that a company must also report on the usage of such a product at a regional or national level.

If an organisation manufactures, distributes, or consumes products or chemicals that are regulated, then it may also be a requirement to manage Product Safety Data Sheets. A product safety data sheet is a document that contains information regarding potential hazard, safe handling, emergency guidance, and other related information about the product. These are also known as material safety data sheets.

Dynamics 365 Setup

Product compliance parameters allow for some flexibility in the management of regulated and restricted products. These are configured in Stock management > Setup > Stock and warehouse management parameters in the Product compliance tab:

The main features of these parameter fields are:

  1. The Administrator user ID allows for the user id for the product compliance administrator. This person will receive notifications outlined in the Product safety data sheet notifications group.
  2. Validity in days defines the default number of days that product safety data sheets are valid following approval.
  3. Expiry advice defines the number of days before the expiration date of product safety data sheets that the system should begin presenting messages.
  4. The Compliance section supports user warnings when product safety data sheets are expired, not recorded in the system, as well as providing a hard stop to specific posting processes. Here is also where the election to print safety data sheets at the same time packing slips are printed.
  5. The Product safety data sheet notifications group sets the options for issuing alerts and warnings to the user ID set as the product compliance administrator.
  6. Annual reporting quantity basis sets the date range as needed to generate reports for compliance purposes.
  7. The Product safety data sheet control group sets the basis to use for determining the effective date for product safety data sheets as transactions are generated. Reason code enforcement may be set here, as well.

The Administrator user ID allows for the user id for the product compliance administrator. This person will receive notifications outlined in the Product safety data sheet notifications group.

  • Validity in days defines the default number of days that product safety data sheets are valid following approval.
  • Expiry advice defines the number of days before the expiration date of product safety data sheets that the system should begin presenting messages.
  • The Compliance section supports user warnings when product safety data sheets are expired, not recorded in the system, as well as providing a hard stop to specific posting processes. Here is also where the election to print safety data sheets at the same time packing slips are printed.
  • The Product safety data sheet notifications group sets the options for issuing alerts and warnings to the user ID set as the product compliance administrator.
  • Annual reporting quantity basis sets the date range as needed to generate reports for compliance purposes.
  • The Product safety data sheet control group sets the basis to use for determining the effective date for product safety data sheets as transactions are generated. Reason code enforcement may be set here, as well.

The next step is to create the material reporting list by country or region. This is done in Stock management > Setup > Product compliance > Regulated products regional lists. Once the required countries or regions (with state specific requirements if necessary) have been created, the Regulated products button is used to add the products that are regulated. (If the product is marked as Reported, the Reported regulated products button is used):

If product safety data sheets are to be managed, an entry for each country/region that safety data sheets will be managed needs to be created via Stock management > Setup > Product compliance > Product safety data sheet validity.

And finally, the product safety data sheets should be added to the released product via the Manage stock > Compliance > Safety data sheet button.

The safety data sheet record allows the uploading of the document to the paper clip icon and should include effective and expiry dates.

When working with purchase orders and items that are designated as regulated, messages such as this will highlight missing or expired safety data sheets.