FDA regulated computer systems must have controls in place to ensure that only authorized users can operate the system; in practice, this means that FDA regulated computer systems are expected to require a password.
Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following:
Security is required for electronic records and/or the systems that generate or access these records. The system and records generated by or contained within the system should only be available to authorized individuals.
Security is usually a combination of physical controls, such as locks on doors which prevent unauthorized personnel from accessing restricted areas of the facility, and logical controls, such as program passwords which require that users log-in before accessing system functionality. Two primary tools for enforcing limited system access are user passwords to access a system and program time-outs to put the system into a locked state when the program is not used for an extended period of time. Document and test (this is usually done as part of system validation) who can access the system and the security that prevents others from gaining access to the system or records.
Compare this requirement with Annex 11 Section 12., Security.
Q: Do all validated computer systems require passwords?
A: User-specific passwords are usually considered superior to other controls, such as a general password to access as system or procedural controls when enforcing compliance. However, if technological solutions are not possible, procedural controls can be considered acceptable, provided that they provide a similar level of system control.
Q: Can you help me make my Access database or Excel spreadsheet compliant with this regulation?
A: The Part 11 Toolkit provides Access databases with all of the technological tools required for compliance with 21 CFR 11, including password protection. ExcelSafe provides similar technological tools to Excel spreadsheets.
Don’t see your question answered?
Contact us and ask us your question. You can also call us at (919) 844 2494.