Regulatory Compliance in Life Sciences

Regulatory Compliance in Life Sciences
Regulatory Compliance in Life Sciences

In the Medical Devices and Biopharmaceutical industries, reporting regulations are constantly changing and reforming. Recent evidence of this is the Physician Payments Sunshine Act's expanded reporting requirements.

Under these regulations, manufacturers of medical devices and biopharmaceuticals will be required to report any payments or transfers of value made to physicians or teaching hospitals. This will become effective in January 2022, which means that Medical Device and Biopharma companies must begin tracking payments and other value transfers by January 2021 in order to file their first report by March 2022.

How Mature is Regulatory Compliance in Your Organization?

In a recent study of compliance integration maturity in Life Science organizations, reactive, or defensive compliance, passive, or superficial compliance, operational, or transactional compliance, strategic, or embedded compliance, and holistic, or fully integrated compliance were identified and described.

These five levels of compliance maturity illustrate the vast gulf between companies that prioritize compliance in their business decisions and those that do not view compliance as a crucial aspect of the product development process.

Regarding quality and regulatory compliance, there are no shortcuts. So, let's assume that mutual respect between producers and regulators is crucial to the success of your product.

The purpose of regulators is not to limit your time to market or profitability. They exist to ensure patient safety, enhance patient outcomes, and decrease healthcare costs. In reality, they exist to ensure that your product meets the highest quality standards possible.

Quality and Compliance Management Best Practices

Regularly, regulatory documentation is reviewed. Consequently, it is essential to ensure that your submissions adhere to current regulatory requirements. Using a digital document and quality management system can aid in data management. Therefore, here are five tips to help you maintain effective document management:


A centralized repository for all documents and procedures ensures that uniform templates with standardized properties are utilized. ENOVIA Quality & Compliance Management on the 3DEXPERIENCE platform, for instance, assists businesses in coordinating and directing operations to meet regulatory requirements.


Through secure, efficient collaboration on documents and materials from a single source of truth, ownership is traceable. By using standardized and streamlined methods and having quick access to data and documentation reporting, teams can reduce inspection time.

User Experience

Maintaining Continuous Quality Improvement requires fostering a culture of quality within your organization (CQI). Providing a simple, intuitive solution that enables automation and consistency in your operations is the most effective method for encouraging user participation.

Flexibility and Security

The solution you choose should be easy to configure, manage, and update, eliminating the need for costly programmers, consultants, and IT specialists to make changes or add steps.

Within certified systems, change process management must be held to a high level of precision. At the file server and shared folder levels, it is essential to preserve a single source of truth within a secure file structure. External security threats must be addressed proactively as opposed to reactively, and document changes must be mapped.

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