- Part 11 will be interpreted narrowly; FDA is clarifying that fewer records will be considered subject to Part 11.
- 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).
- FDA will enforce all predicate rule requirements, including predicate rule record and recordkeeping requirements.
- 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.
- 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.
- 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.
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