Microsoft Dynamics Nav

Regulatory Compliance

Picture4

The pharmaceutical industry operates in one of the world’s most regulated environments. To maintain a licence to operate, they must comply with the regulations

There are industry specific compliance obligations, such as Good Distribution Practice (GDP) Good Clinical Practice (GCP), Good Vigilance Practices (GVP) and Good Manufacturing Practice (GMP) to mention a few. Accurately interpreting the legislation and implementing any necessary changes in a co-ordinated, cost efficient and timely manner, across a number of business functions, has tested the capabilities of the industry.

ERP software system like Microsoft Dynamics assist a long way to help the companies in complying with the regulations. PharmaTotal takes it further in assisting Pharmaceutical Wholesalers, Manufacturers and Retailers in adhering to the regulations. Some of the features of the system are

1. Company Licenses – PharmaTotal has features for storing WDA/CD/GDP/GPHC and more licenses for suppliers and customers. System alerts the users when a license needs to be reviewed and restricts from trading in product categories that are not allowed for a particular supplier or customer

2. Product Setup – Using the product setup in PharmaTotal users can store product categorisation, storage temperature, active ingredient quantity, strength which enables the system to create notifications, reports for several scenarios.

3. General Features – The powerful platform of Microsoft Dynamics provides features such as batch tracking, audit trail, user restrictions, product approval, backup and recovery which assist in companies complying with annexure 11 or alike regulatory requirements.

4. Product Licenses – PharmaTotal has various modules for license management of products such as Marketing Authorisation for parallel import, Approvals for Unlicensed Medicine import, CD import & export and more. Various notifications and validation messages come up in the  system depending on the business process requirement.

5. Documentation – PharmaTotal allows users to store and generate several documents that are required for regulatory compliance. Some of the examples are Certificate of Analysis (COA), Certificate of Conformity (CoC), Batch Manufacturing Report (BMR), Label Printing. These documents are generated or attached batch wise in the system to enable users to easily search and reprint such documents.