FDAA Cfr Part 11 Regulation On Electronic Quality System

By: Marci Lynn Crane

If you’ve dealt with a paper based quality system or even with a hybrid quality system, an online, centralized, electronically regulated quality system probably sounds like something akin to Nirvana, which probably isn’t far from the truth…at least as far as quality systems go!

The FDA Agrees
The FDA too finds electronic quality systems (especially during audits) to be far more effective and efficient. Electronic submissions for pharmaceuticals and clinics are also far more effective---for everyone. The FDA however is still “on the job” and has worked to develop appurtenant regulations for electronic quality systems.

21 CFR Part 11
Simply put, regulation http://mastercontrol.com/regulations/part11.html"">21 CFR Part 11 (1997) allows companies to utilize electronic archiving systems and accepts electronic signatures as valid. This FDA decision was a landmark one since it essentially takes manual quality systems and “okays” their virtual counterparts which as most professionals are aware are far more effective.

Which online quality system will suit your company best?
Even though you know (and the FDA knows) that electronic quality systems are more effective than paper-based or hybrid systems, it can still be a difficult enterprise trying to find the best quality system for your company. However, Regulation 21 CFR Part 11 can act as a guide for your quality system shopping spree.

21 CFR Part 11 Requirements
Take a look at the following 21 CFR Part 11 requirements and determine whether or not your potential quality systems are performing up to standard.

Part 11 Section 11.101
In Part 11 Section 11.10 it is apparent that the control of documentation is essential for the quality system that you decide to invest in. The section emphasizes “ensur[ed] authenticity, integrity, and when appropriate confidentiality of electronic records.” In other words, look for a quality system that will manage documents but not just your quality documents; look for a system that will manage any company document including any documents associated with regulatory compliance.

Part 11 Section 11.102
In Part 11 Section 11.10, the “minimiz[ation] [or the] possibility of repudiation by signer,” is required. In other words, look for a quality system that makes sure your process isn’t going to end up in production just to end up going backwards in a chain of failed quality. Look for a quality system that can set up customized routes of approval and make sure that the quality system also provides solid protection against unauthorized user break-ins (look for SQL protection for instance).

Part 11 Section 11.10a3
In Part 11 Section 11.10a it becomes apparent that validation is important to the FDA and rightly so. Make sure to look for a quality system that provides validation services. If a company provides validation services for their own software solutions, chances are they know valuable OQ, IQ, etc. procedures backwards and forwards.

Part 11 Section 11.10 i4
Part 11 Section 11.10i requires that training has taken place for all persons who utilize the quality system. The FDA needs to know if regulated company employees are capable of doing what they say they can do. Look for a quality system that provides training management and training control. Perhaps you thought such “an animal” didn’t exist. Think again! Many quality and compliance tasks, responsibilities and procedures can now be integrated into unified and streamlined processes. Look for a quality system that can grow and that already has plenty of options for your company’s needs.

When all is said and done, finding a quality system seems essential when you factor in today’s regulatory and “demand-for-quality” expectations. Search for the quality system that fits the characteristics mentioned above and you’ll have found a quality system worth considering.

1-4 mastercontrol.com/regulations/part11.html

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