This guidance is intended to describe the FDA's current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations (CFR); Electronic Records; Electronic Signatures and is in effect since August 20 1997.
Approach to Specific Part 11 Requirements
The Agency intends to exercise enforcement discretion with regard to the part 11 requirements for the:
1. Validation : validation of computerized systems. consider the impact those systems might have on the accuracy, reliability, integrity, availability, and authenticity of required records and signatures.
2. Audit Trail : exercise enforcement discretion related to computer-generated, time-stamped audit trails. Audit trails can be particularly appropriate when users are expected to create, modify, or delete regulated records during normal operation.
3. Legacy Systems : If all the following criteria are met for a specific system:
• The system was operational before the effective date
• The system met all applicable predicate rule requirements before the effective date
• The system currently meets all applicable predicate rule requirements.
• You have documented evidence and justification that the system is fit for its intended use (including having an acceptable level of record security and integrity, if applicable)
If a system has been changed since August 20, 1997, and if the changes would prevent the system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 records and signatures pursuant to the enforcement policy expressed in this guidance.
4. Copies of Records : for generating copies of records and any corresponding requirements. We recommend that you supply copies of electronic records by:
• Producing copies of records held in common portable formats when records are maintained in these formats
• Using established automated conversion or export methods, where available, to make copies in a more common format (examples of such formats include, but are not limited to, PDF, XML, or SGML)
5. Record Retention : protection of records to enable their accurate and ready retrieval throughout the records retention period. Persons must still comply with all applicable predicate rule requirements for record retention and availability. Maintaining records be based on the decision on a justified and documented risk assessment and a determination of the value of the records overtime.
Reference - Guidance document Part 11, Electronic Records; Electronic Signatures - Scope and Application
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