Ask Linda: Keeping Up with Regulatory Compliance

Dear Linda,
Regulatory compliance is a top concern for our analytical lab organization. In recent years, the combination of continuously evolving regulations and the digitization of many laboratory process and technologies is making it difficult to keep up with compliance efforts across the organization. What are some strategies we can implement to improve our compliance efforts, especially to meet the strict requirements for data integrity?

Sincerely,
Jonathan

Dear Jonathan,
Achieving regulatory compliance can certainly be challenging. A good starting point is to designate compliance responsibilities, and ensure these individuals have the appropriate knowledge and training to perform these duties. It is also important to include compliance responsibilities in job descriptions for new hires.

There are also a few technology solutions that can support the lab in meeting data integrity requirements in the context of increased digitization. Many instruments, from benchtop equipment such as balances and moisture analyzers, to remote monitoring devices and software are manufactured with specific features to support 21 CFR Part 11. A laboratory information management system (LIMS) can also be leveraged to automate various processes necessary for compliance.

For external support, your lab may wish to consider working with a compliance service provider.

Best wishes,
Linda