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. It is only meaningful for instruments connected to a computer and using software.
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.
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.
Find suggestions for a more secure and automatic dataflow solution with LabX. 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. 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. already are validated.
Extract of the content:
- Why would someone ask for such a solution?
- Background Information:
- USP <1058> (2017 version),
- Stand Alone Systems and Printer Records
- ALCOA rules
- Raw data definition from 21 CFR 58.3(k), April 1 2016
- Frequently asked Questions
- Calibration data and methods are electronically stored on the instrument. Aren't these electronic records?
- Which setup involves the least cost, time and effort?
- What is the biggest advantage of a LabX Solution in this context?