| Many suppliers in China are confused by the FDA | | | | more time to determine the best strategy forward, |
| requirements. This has further added to the | | | | and HOPE that the early adopters will out all the |
| headaches when overseas sourcing professionals are | | | | bugs, where a clean, simple version of Part 11 will be |
| trying to identify suppliers that are FDA compliance. | | | | available for late comers to follow. So, what shall an |
| In the FDA maze, FDA 21 CFR Part 11 -- Electronic | | | | average medical device development firm do in order |
| Records; Electronic Signatures -- (Part 11) has | | | | to prepare itself for future compliance? |
| generated quite a bit of press. For those who are | | | | |
| unfamiliar with the requirement, I recommend a quick | | | | 1. Generate a log of documents related to the |
| and brief review of the FDA guidance located in the | | | | medical device, and specify whether the master |
| public domain. In short, FDA has dictated the use of | | | | document is being kept electronically, or on paper. For |
| the Part 11 guidance in March, 1997. Under | | | | those who have not invested in document control |
| widespread scrutiny by the industries, stating that | | | | software, the form could be done using a simple |
| the original guidance may not be consistent with | | | | Excel tracking sheet. Further, please clearly states on |
| FDA's original intent in issuing the rules, and other | | | | the tracking sheet and on the document that only |
| factors, FDA has withdrawn the original guidance, but | | | | the printed version kept in the master document |
| remained firm on the future usage of the Part 11. | | | | control area can be considered as the "controlled" |
| During the transition period to full Part 11 compliance, | | | | version. |
| the FDA has outlined 3 main elements of the | | | | 2. Do NOT implement a partial solution as suggested |
| guidance: | | | | by the Part 11 guidance, i.e. only part of the |
| | | | documents is Part 11 compliance. Some may be |
| 1. Part 11 will be interpreted narrowly; FDA is clarifying | | | | tempted to implement a "pilot" solution to test out |
| that fewer records will be considered subject to Part | | | | the document control software, or other software |
| 11. | | | | packages. However, this will only prompt for |
| 2. For those records that remain subject to Part 11, | | | | attention during an audit. Please remember a paper |
| FDA intends to exercise enforcement discretion with | | | | tracking mechanism will NOT harm you, but an |
| regard to Part 11 requirements for validation, audit | | | | incomplete electronic trail will.. |
| trails, record retention, and record copying in the | | | | 3. Do start NOW with a pilot project. As with any |
| manner described in the guidance and with regard to | | | | kind of software adoption project, implementing the |
| all Part 11 requirements for systems that were | | | | solution to all stakeholders will take some time. A pilot |
| operational before the effective date of part 11 (also | | | | project will minimize any confusion for users. It will |
| known as legacy systems). | | | | also help to flush out any bugs before rolling out the |
| 3. FDA will enforce all predicate rule requirements, | | | | solution corporate wide. Many companies offer |
| including predicate rule record and record keeping | | | | specific modules tailored for FDA compliance, i.e. |
| requirements. | | | | Siemens FDA accelerator. |
| Basically, instead of a full-blown industry wide | | | | FDA compliance is not as daunting as most thought. |
| adoption, FDA will now use "discretion" and | | | | On another hand, having the ability to comply with |
| "interpretation" when auditing for Part 11 compliance. | | | | FDA will not only give your company and product the |
| This, obviously, is good news for most firms that are | | | | needed edge over your competitors, it may also |
| not yet FDA compliance. However, the delayed | | | | force your company to have tighter quality |
| guidance only means that companies will now have | | | | standards. |