Many suppliers in China are baffled by the FDA. This has further added to the source of headaches when foreign experts are trying to identify the suppliers that are FDA compliance. In the maze of FDA, FDA 21 CFR Part 11 - Electronic Records, Electronic Signatures - (Part 11) was generated very little press. For those who are familiar with the application, I recommend a quick and brief overview of FDA guidelines is in the public domain. In short, the FDA has dictated the use of 11th part of the leadership in March 1997. Under the pervasive control by the industry, stating that the original guidelines should not be in accordance with the FDA's original intent in issuing the rules, and other factors, the FDA withdrew the original guidance, but remained firmly on the future use of the 11th During the transition period to full compliance part 11, FDA stated 3 main elements of leadership:
Part 11 will be interpreted narrowly, FDA is clarifying that fewer records will be considered subject to Part of the 11th For those records that remain subject to Part 11, FDA intends to exercise enforcement discretion with regard to part of the application 11 for validation, audit trails, record retention and record copying in the manner described in the guidance is given to all Part 11 requirements for systems that are operational prior to the entry into force of section 11 (also known as legacy systems). FDA will enforce all predicate rule requirements, including predicate rule record and record-keeping requirements.
Basically, instead of full-blown industry wide adoption, the FDA will now use "discretion" and "interpretation" when the audit for 11 part of the assessment. This is obviously good news for most companies that are not yet FDA compliance. However, delayed the lead just means that companies will now have more time to determine the best strategy forward, and we hope that early adopters from all bugs, where pure, simple version of Part 11 will be available for late comers to follow. So, what will the average medical device development companies do to prepare for a future meeting?
Create a log of documents in connection with medical devices, and determine whether the master document is stored in electronic form or on paper. For those who have not invested in a document control software, the form can be done using a simple Excel tracking sheet. In addition, please clearly states to monitor the situation and the document is only printed edition is kept in the control of the main document area can be considered as "controlled" version. is not implemented partial solutions as proposed by the 11th part of the guidelines, or just part of the documents on 11 Part of the regulations. Some May be tempted to implement a "pilot" to test the software solution for document control, or other software packages. However, this will require attention during the audit. Note the mechanism for monitoring the work will not harm you, but incomplete electronic trail will .. Do not start now with a pilot project. As with any kind of software adoption project, implementing a solution for all parties concerned will take some vrijeme.Pilot project will reduce any confusion for users. It will also help to flush out any bugs before rolling out a corporate wide solution. Many companies offer specific modules tailored for FDA compliance, ie Siemens FDA accelerator.
FDA compliance is not as scary as people think. On the other hand, have the ability to comply with the FDA will not only give your company and products needed edge over your competitors, it also can force your company to have tighter quality standards.
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