Prior to validating your computer systems, it’s important to gauge the impact it will have on compliance moving forward. The FDA uses its own discretion to enforce particular requirements of Part 11 for validation of computerized systems. Common software, such as LabX, has to be validated only once and every new analytical instrument attached will just require an amendment via change control as the software, data management, audit trail, user management, result flow etc. Enforcing Part 11 and Validating Electronic Records. This can be used for a lean automated electronic data integrity solution and can connect many of your lab instruments with reduced documentation and qualification effort. XnView MP is a revised and upgraded version of XnView, a highly popular, free-for-home graphics viewer that is an. Please read why experts state, that standalone instruments cannot be 21 CFR Part 11 compliant and concepts offered in the market that look like a feasible workaround are rather dangerous because they may result in a data loss and even worse scenarios.įind suggestions for a more secure and automatic dataflow solution with LabX. Several companies from the pharmaceutical industry have recently asked for 21 CFR Part 11 certification for instruments not connected to a PC, just using the instruments' firmware. Part 11 applies to (and I'm quoting from the regulation) 'records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations.' So first off, you need to realize that if the regulation doesn't require a record, Part 11 doesn't apply. It is only meaningful for instruments connected to a computer and using software. 21 CFR Part 11 is a regulation that defines the criteria for ensuring trustworthy and reliable electronic records and electronic signatures in computerized systems of FDA regulated pharmaceutical industries.
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