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A Shortcut to FDA 21 CFR Part 11 Compliance

Jason Fong

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Many suppliers in China are confused by the FDA requirements. This has further added to the headaches when overseas sourcing professionals are trying to identify suppliers that are FDA compliance. In the FDA maze, FDA 21 CFR Part 11 - Electronic Records; Electronic Signatures - (Part 11) has generate quite a bit of press. For those who are unfamiliar with the requirement, I recommend a quick and brief review of the FDA guidance located in the public domain. In short, FDA has dictates the use of the Part 11 guidance in March, 1997. Under widespread scrutiny by the industries, stating that the original guidance may not be consistent with FDA's original intent in issuing the rules, and other factors, FDA has withdrawn the original guidance, but remained firm on the future usage of the Part 11. During the transition period to full Part 11 compliance, the FDA has outlined 3 main elements of the guidance:

  1. Part 11 will be interpreted narrowly; FDA is clarifying that fewer records will be considered subject to Part 11.
  2. For those records that remain subject to Part 11, FDA intends to exercise enforcement discretion with regard to Part 11 requirements for validation, audit trails, record retention, and record copying in the manner described in the guidance and with regard to all Part 11 requirements for systems that were operational before the effective date of part 11 (also known as legacy systems).
  3. FDA will enforce all predicate rule requirements, including predicate rule record and record keeping requirements.

Basically, instead of a full-blown industry wide adoption, FDA will now use “discretion" and “interpretation" when auditing for Part 11 compliance. This, obviously, is good news for most firms that are not yet FDA compliance. However, the delayed guidance only means that companies will now have more time to determine the best strategy forward, and HOPE that the early adopters will out all the bugs, where a clean, simple version of Part 11 will be available for late comers to follow. So, what shall an average medical device development firm do in order to prepare itself for future compliance?

  1. Generate a log of documents related to the medical device, and specify whether the master document is being kept electronically, or on paper. For those who have not invested in document control software, the form could be done using a simple Excel tracking sheet. Further, please clearly states on the tracking sheet and on the document that only the printed version kept in the master document control area can be considered as the “controlled" version.
  2. Do NOT implement a partial solution as suggested by the Part 11 guidance, i. e. only part of the documents is Part 11 compliance. Some may be tempted to implement a “pilot" solution to test out the document control software, or other software packages. However, this will only prompt for attention during an audit. Please remember a paper tracking mechanism will NOT harm you, but an incomplete electronic trail will. .
  3. Do start NOW with a pilot project. As with any kind of software adoption project, implementing the solution to all stakeholders will take some time. A pilot project will minimize any confusion for users. It will also help to flush out any bugs before rolling out the solution corporate wide. Many companies offer specific modules tailored for FDA compliance, i. e. Siemens FDA accelerator.

FDA compliance is not as daunting as most thought. On another hand, having the ability to comply with FDA will not only give your company and product the needed edge over your competitors, it may also force your company to have tighter quality standards.

Jason Fong, managing partner of a company specializes in providing the BEST vendor assessment service in China for Medical, Automotive, and Industrial clients overseas. Our service not only allows the client to make informed strategic sourcing decision in an efficient manner, but also enjoy the seamless supplier relationship enhanced by having a local representative.

As the procurement industry progresses, SourceLimit believes that companies will no longer tolerate the 10% - 30% commission charged on every purchase order. Instead, a fee for service, consultation based service will be the new business model. SourceLimit adds value to your global procurement office by having local presence at a nominal cost. This allows you to reap the benefits of global sourcing, without having to maintain a fully staffed offshore procurement office.

For more articles on Strategic Sourcing in China, please visit our blog on


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