Benefits Of Automating Regulatory Compliance In The Pharmaceutical Industry

Posted on: 12 May 2020

Pharmaceutical companies grow like cobwebs—in different directions and at different speeds. You may make several acquisitions to expand your presence throughout Asia. Meanwhile, you may have entered the Latin American market by outsourcing marketing and distribution. Often times, global compliance and regulation standards get caught in this web of different enterprise systems with different levels of integration. 

One way to get unstuck is by automating compliance and regulatory processes throughout your global operations. Regulatory infractions can be costly and, at worst, lead to business failure. 

More Efficient Allocation of Resources

When done manually, pharmaceutical compliance and regulation involves high resource allocation. You must understand how to apply myriads of rules and painstakingly collect and analyze large amounts of data to ensure compliance with those rules. When automated, in contrast, mapping rules and procedures to business units and processes make it easy to apply changes and updates across the board. Employees can focus on higher value-added activities.

The critical engine of a compliance and regulatory system is the knowledge of how to apply rules and regulations to your business. Global pharmaceutical regulatory specialists understand how to apply rules by business group and process. If there is a gray area, they liaise with government regulatory bodies to clarify issues. These specialists also oversee global regulatory publishing services, ensuring that information is disseminated in understandable language to all corners of your enterprise and supply chain in a timely manner.

Streamlined Auditing

Responses to internal and external auditor requests and clarifications can be immediately generated within minutes. Audit trails are more transparent and more easily tracked. If a non-compliance issue arises, activity logs can be consulted, the source of the breach identified, and any exceptions analyzed. Making auditors grumpy spending hours sifting through data is never a good idea.

Omnichannel Product Data Harmonization

The integration of global compliance and regulations with product data is a logical step. Standardizing product identification, including brand name, ingredients, dimensions, and so forth, streamlines information among all channels and partners across regions. This harmonization also ensures the consistent application of product regulations throughout the omnichannel. 

All industries are moving towards GS1 product data standards to achieve product data interoperability. Harmonizing product data with GS1 standards in the pharmaceutical and healthcare supply chain is helping to facilitate regulatory compliance on a product level. 

All of the above benefits of regulatory automation—improved resource allocation, suitability, and product trackability—improve data integrity and security. Improve data governance, and improves data quality which, in turn, lowers regulatory compliance risk. For more information, reach out to a global regulatory publishing service