FDA 21 CFR PART 11 COMPLIANCE

21 CFR: The Umbrella Of FDA Compliance

The U.S Food and Drug Administration (FDA), the Office on National Drug Control Policy (ONDCP) and the Drug Enforcement Agency (DEA) all use Title 21 Code of Federal Relations (CFR) to govern food, drugs, cosmetics and other public health products. When it comes to enforcement, inspections can be conducted for the purpose of pre-qualification, routine inspection, or “for-cause” to investigate a specific problem reported to the FDA – so you need to be consistently ready.

 

Title 21 CFR, Part 11

Title 21 CFR Part 11, in particular, is all about electronic signatures, electronic records, and ensuring that both components are trustworthy, reliable and equivalent to paper records (ERES). Generally speaking, part 11 applies to medical device manufacturers, drug makers, biotech companies, and other FDA-regulated industries.

 

This focus on electronic records may seem oddly specific, but establishing a trustworthy, consistent electronic paper trail is a major time-saver and necessary for maintaining record standards in a modern age. Before part 11 was established in 1997, institutions had to submit physical documents to be audited, and it cost a lot of time, physical space and efficiency. 21 cfr part 11 compliance makes it much easier to prove compliance and to comply with other regulatory sections.

Make Sure 21 CFR Part 11 Applies To Your Company

According to section 11.3, the term “electronic record” is defined as, “any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system.” This is a broad definition that shows that Part 11 will apply to many companies.

 

For this reason, even if you have paper-based systems, it’s likely that 21 CFR Part 11 can apply to your business.

 

 Follow 21 CFR Part 11 Password Protection Best Practices

Part 11 is ultimately all about data security and the security of your electronic records. Facilitating compliance, then, will require that you follow security practices and set the right roles and permissions when it comes to your data. It also requires effective password protection.

 

Validate For IQ, OQ And PQ

Most validation projects follow the IQ, OQ, PQ process for system validation. This, of course, stands for installation qualification, operational qualification and performance qualification. The process can ultimately demonstrate that:

 

The installation of the facility, product line, equipment, and systems are installed with a high degree of quality assurance and in accordance with all FDA quality requirements.

The quality of the production process meets FDA standards.

The quality of the documentation about the process and equipment meets FDA standards.

It’s important to get right, and the right FDA compliance software can help.

 

4. Create Clear Audit Trails

If you have a clear and accurate audit trail, it can make the entire auditing process easy and intuitive. This can help with part 11 compliance because it can allow your team and auditors to understand, at a glance, when records were created, changed, deleted or superseded.

 

To get this right, you need comprehensive change management processes.

 

5. Make Sure Your Compliance Is Properly Handled

The responsibility of Part 11 compliance will always fall on your shoulders – and, since you’re ultimately responsible, you should be the one crossing your T’s and dotting your I’s. That said, in-house validation is often costly, time-consuming and complex – particularly as regulations change over time.

 

The right validation-as-a-service system, like Meridian Cloud for Life Sciences, can help take the majority of the validation process of your plate using features like:

 

Pre-validated Meridian implementation  

Templated validation documentation  

Customer-specific validation documentation modifications   

Data migration (test and production)  

User acceptance testing  

Deployment, with the execution of the OQ and data migration protocol  

Additionally, Accruent will be there every step of the way from system design through deployment. Then, once your system is deployed, Accruent Managed Services (AMS) will provide your team with ongoing support in the form of:  

 

Re-validation of the core solution for each Quarterly Release 

Templates updated, if necessary 

Re-testing of core solution  

Risk assessment of changes relative to your configuration (assigned a risk level of 1, 2 or 3)  

Re-validation on level 3 items against your configuration

This not only saves time but also decreases your team’ IT burden and frees up time for the execution of other business-critical tasks.