Science With Purpose

Necessary, But Not Necessarily Enough: Looking Beyond Title 21 CFR Part 11

August 4, 2020
Click Here to View All Blogs About

Pharmaceutical boards, regulatory agencies, and drug manufacturers work to ensure that they maintain the highest standards for public health and safety. To make sure that these expectations are met, regulations are put in place – from the Food and Drug Administration to the Medicines and Healthcare products Regulatory Agency and the World Health Administration – there are organizations and agencies all over the globe determining quality during manufacturing processes.

One regulation that is often referenced for quality standards is Title 21 CFR Part 11. It states that FDA-regulated industries must have systems in place that protect electronic data, including audits, system validations, and more. However, pharmaceutical manufacturers must not limit themselves to what is stated in Title 21 CFR Part 11 and should continue to innovate ways to safeguard data integrity, especially as technology evolves and processes change accordingly.

Some ways to remain proactive about data integrity include:

Stability testing

In the process of drug development and approval, stability testing works to determine the safety of a drug and its shelf life. Ensuring that you have a strong stability testing program, which includes proper data integrity, will save your organization from future violations. Manufacturers must be able to provide solid documentation that helps avoid customer risk, as well as highlight threats for their products.

Implementing the proper systems and technologies

Data integrity is essential for maintaining proper quality standards. You will face violations if your organization fails to document your test methods properly, like reproducibility, accuracy and sensitivity. Your organization can avoid violations regarding data integrity and computer system validation by ensuring strong and clear practices from the beginning, before manufacturing has even begun.

Data quality controls with technology and instrumentation

Pharmaceutical manufacturers use complex analytical instruments and techniques for working with drug products, primary packaging, and beyond. While it was acceptable in the past for instrument software to not be inherently compliant (if it could function with workarounds), that is no longer allowed. Regulatory agencies view this as a consumer safety risk and systems are now evaluated based on inherent compliance. This means that manufacturers need to stay ahead with their quality programs so that they not only meet current regulations but can adapt to future ones, as well. The goal? Enhanced instrumental compliance that requires minimal manual intervention.

Using a third-party partner

Working with a third-party partner that is knowledgeable in the best practices and programs to guarantee data integrity can be an effective way for your manufacturing facility to get ahead and face limited disruptions as it continues to focus on creating safe and useful medications for the public.

If you’re looking to learn more about how you can guarantee your company’s compliance and help your scientists focus on their goals without distractions, you can read our article here.


Stay up-to-date with the latest insights and trends, customized to your market and interest.