Instructions vs. Records

Two types of documents carry every GxP quality management system. Instructions (specifications, procedures, plans) are reviewed and approved before release – approved, signed and dated; signed alongside the instructions are the evaluating reports that carry the release decision. Records evidence execution as instructed – contemporaneous and truthful, with traceable changes; their standard is ALCOA++. A signature per record is not required – attribution is provided by the controlled system: the signature follows the decision, not the record. Form is free, but not formless: EU GMP Chapter 4 explicitly allows documentation to be paper-based, electronic or photographic – but requires that the media used be fully defined in the QMS and that suitable controls ensure accuracy, integrity, availability and legibility. The device standard ISO 13485 calls records, in its normative text, “a special type of document” (4.2.4).

See also: Electronic Record, Audit Trail, Data Governance, Quality Management.