Glossary

26 terms, no jargon defining jargon. Each one opens into a fuller explanation, written the way a colleague would put it across a desk.

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ALCOA+: The nine attributes of trustworthy data: attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring and available. More
Annex 11: The EU GMP annex governing computerised systems. The European counterpart and complement to FDA's Part 11, broader in lifecycle scope. More
Audit trail: A secure, computer-generated, time-stamped record of who did what to a record and when, including what the value was before. More

CAPA: Corrective and preventive action. The quality system's engine for making problems stay fixed. More
Change control: The formal process that decides whether a change to a validated system is allowed, what testing it needs, and who approves it. More
CSA: Computer Software Assurance. FDA's risk-based reframing of software validation: assurance effort proportional to patient and quality risk. More
CSV: Computer System Validation. Documented evidence that a computerised system does what it is intended to do, reliably and repeatably. More

Data integrity: The degree to which data is complete, consistent and accurate across its lifecycle. The thing every other control exists to protect. More

eQMS: Electronic quality management system. Where deviations, CAPAs, change controls and documents live once paper is retired. More
ERES: Electronic records, electronic signatures. The subject matter of 21 CFR Part 11. More

GAMP 5: ISPE's good practice guide for GxP computerised systems. Source of the software categories and the V-model everyone sketches on whiteboards. More
GxP: The family of good practice regulations: GMP for manufacturing, GLP for laboratories, GCP for clinical trials, and their siblings. More

IQ / OQ / PQ: Installation, operational and performance qualification. Proof that a system is installed right, works right, and works right for your process. More

LIMS: Laboratory information management system. Manages samples, tests, results and the lab's chain of custody. More

MES: Manufacturing execution system. Runs electronic batch records and shop-floor execution between ERP and the equipment. More

Part 11: 21 CFR Part 11. The FDA regulation setting conditions under which electronic records and signatures are trustworthy and equivalent to paper. More
Periodic review: A scheduled check that a validated system is still in its validated state: changes reviewed, access sane, audit trails functioning. More
Predicate rule: The underlying GxP regulation that requires a record to exist at all. Part 11 only governs records a predicate rule demands. More

Risk assessment: The exercise of deciding what can go wrong, how badly, and how likely, so that effort lands where failure hurts. More

SDLC: Software development lifecycle. The path from requirement to retirement; validation is its GxP-flavored shadow. More
SOP: Standard operating procedure. The written way a thing is done, and the standard an inspector holds you to. More

Traceability matrix: The map linking requirements to risks to tests, proving every requirement was verified and nothing was tested into the void. More

UAT: User acceptance testing. The moment real users confirm the system supports the actual process, not the imagined one. More
URS: User requirement specification. What the system must do, written before anyone falls in love with a product demo. More

Validation master plan: The top-level document defining what gets validated at a site, by whom, and to what standard. More
Vendor audit: The structured assessment of a supplier's quality system, deciding how much of their testing you can lean on. More