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Will 21 CFR 11 Hinder My Compliance Efforts?

March 31st, 2015 by James Francum

Electronic Records ManagementElectronic records are complex by nature. While they ostensibly serve as evidence of compliance efforts and regulatory adherence, their validity is entirely dependent on the systems that maintain them. Fail to keep your record-storage network secure, for instance, and any data security breach that affects your documentation also compromises your attempts to establish that you've been following the rules in the first place. 

Furthermore, for the regulatory authorities – both European and in the US – a failure to comply with the regulations concerning the compliance of electronic records and signatures also means a loss of your data integrity.

If you maintain closed data systems as part of your compliance architecture, you should pay close attention to documents like 21 CFR Part 11. As data networks become even more pervasive and ubiquitous within GMP processes, you'll need to fortify your IT & embedded systems in adherence with regulatory guidelines.

Who's Impacted by 21 CFR Part 11?

Some GxP-regulated firms will have to take obvious actions in response to Title 21 sections like Part 11. For instance, if your company produces medical devices that employ EMR records to keep track of patient data, you'll be compelled to include features that control who gets to access said information and encrypt it prior to transmission. 

If you only consider the obvious situations, however, you'll miss out on Part 11's extensive scope. Say you're a pharmaceutical manufacturer who creates a specific drug; because the drug is a pill that doesn't incorporate any technology the end user has to deal with, you may think you're exempt from this part of Title 21. This would be a wrong assumption.

In reality however, the computer systems you use to keep track of information during initial premarket trials and the shipping, warehousing and distribution processes all fall under the purveyance of FDA regulations. These regulations not only include the predicate rules but also 21 CFR Part 11. For organizations that employ cloud computing, validation and compliance can be extensive tasks. Cloud computing in particular needs to carefully issues involving the Part 11 Final Ruling.

What Do I Need to Do to Get Compliant?

It's essential to read 21 CFR Part 11 thoroughly to appreciate how many facets of the record-keeping and use processes it impacts. For instance, in addition to maintaining your records in a secure condition, you also need to enact controls for seemingly basic operations, like generating copies for inspection and review.

While your staff probably won't have to go as far as building entirely new apps to format and create document hard copies, you still need to ensure that such mechanisms exist. 

The way you currently maintain electronic records could even include deficiencies you're unaware of. Companies whose employees are accustomed to overwriting old records, for example, might be surprised to learn that changes may be frowned upon if they obscure old information without adhering to the proper standards. Without an audit mechanism in place to establish time-stamped audit trails, you'll find it much harder to remain compliant while engaging in routine business practices. 

Taking Advantage of the Regulations 

The more complicated computer networks become, the more difficult it is for their owners to bring them into line such that they become compliant. What you need is a workable plan for assessing the validity of your current electronic record management systems. Whether this is founded on FDA software validation principles, electronic signing mechanisms or IT security theory will ultimately depend on the existing nuances of your record management practices. 

GxP-CC consultants help FDA-regulated organizations use complex rules to identify guidelines they can actually follow.

Contact us to discover how to use Title 21 CFR Part 11 to make your electronic record practices more compliant.


Posted in Compliance Consulting, electronic record management systems, FDA regulations

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James Francum

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