Five Tips To Comply With FDA 21 CFR Part 11

posted by Chris Valentine

FDA regulations are as complex as they are important. One can often feel lost amid the myriad updates which come through both from and in regards to the FDA. However, it’s important to remember that these regulations are in place to safeguard the health of the country as a whole. It’s also important to keep in mind that one will find this process considerably easier by focusing on each individual update. For example, keeping five tips in mind will help anyone comply with FDA 21 CFR part 11.

1. Industries regulated by 21 CFR part 11

One should begin studying CFR part 11 compliance by considering what falls under this designation. This is made somewhat difficult by the scope of this particular law. CFR part 11 compliance regulates industries as wide as pharmaceuticals, biologics, medical devices, and food products for both human and animal consumption.

2. Levels of control for 21 CFR part 11

One can best understand CFR part 11 compliance by breaking levels of control into three separate components. These components consist of administrative, procedural, and technical controls. The administrative controls relate to policies for electronic records. The procedural controls relate to items such as SOPs for using a system. And finally, the technical controls relate to functions built into the software. These ensure integrity reliability for electronic records and systems.

3. The purpose of the law

One needs to understand the law in the context of day to day operations within a wide variety of industries. Properly adhering to the might feel needlessly complex at the start. However, it’s important to remember why 21 CFR Part 11 was put in place.

The purpose of this law involves the proper regulation of electronic records and signatures. Consider how a pharmacy operates. If someone fills a prescription for scheduled substances than multiple signatures are required. This usually involves a technician, pharmacist, and patient. What constitutes a legal signature? One can imagine the issues which would come up if one or more signatures came into question. 21 CFR part 11 is in place within the respective industries in order to prevent this confusion. As well, it helps to protect people from any legal issues which might arise from confusion over the validity of signatures.

4. Automating the process

At this point two things are clear. Compliance with 21 CFR part 11 is both important and complex. This will often make people more than a little nervous about how well they can keep up with the law. Thankfully compliance can be automated to a large extent. Some electronic record management systems, such as CytExpert, have been updated for compliance with the new regulations. This also includes compatibility with systems that make use of it. For example, the CytoFLEX flow cytometer platform makes use of this capability in CytExpert.

5. Making full use of software solutions

An earlier point highlighted automated software solutions. One can take this a little further as well. Proper use of compliant software will bring about some additional benefits simply by the nature of the systems.

For example, one might make use of CytoFLEX for 21 CFR part 11 compatibility via CytExpert v2.3. In doing so one will also gain some additional security features. This includes data integrity control, checksums, audit trails, and of course the document control. The latter also deals with the signatures regulated by 21 CFR part 11 in regards to hierarchy and archiving. This is an additional benefit of ensuring full compliance. There’s often some extra work at the very start. However, once that’s finished one will gain some additional benefits.

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