Organizations who use computer systems in FDA regulated environments must document the operations the system performs, the system configuration required to operate correctly, and the testing that demonstrates that the system operates according to the defined specifications. This process is called validation.
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:
Validation is required for computer systems. This may include a Master or Project specific Validation Plan (VP), a Functional Requirements Specification (FRS), a System Design Specification (SDS), Test Protocols and Validation Summary Report (SR). Validation should include testing that demonstrates that the system can identify any changes made to a record.
Compare this requirement with Annex 11 Principle and Section 4., Validation
Validate the computer system, following your organizations defined procedures for validation.
More information is available about computer system validation.
Q: Which computer systems require validation?
A: If a computer system is used to provide information to regulatory body (such as the FDA), or meet requirements for the regulatory body, the system must be validated.
Q: I have a simple spreadsheet. Does it have to be validated?
A: 21 CFR 11 makes no distinction between types of computer systems; all computerized systems used to meet regulatory requirements should be validated.
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