Glossary

The FDA regulation governing electronic records and electronic signatures, including their trustworthiness, reliability, and equivalence to paper records.

Software components whose behavior is learned from data (machine learning) or that otherwise exhibit adaptive, non-deterministic behavior, rather than following fixed, hand-written logic.

An industry mnemonic for the attributes expected of a trustworthy record: Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available.

A secure, computer-generated, time-stamped record that lets an organization reconstruct who did what to an electronic record, and when.

A structured process for investigating quality problems, correcting them, and preventing recurrence.

A formal process for proposing, evaluating, approving, and documenting changes to a validated system, process, or product before they take effect.

The gap that opens between a system’s documented, validated configuration and its actual, currently-running configuration as small changes accumulate over time.

A risk-based approach to establishing confidence that software used in production or a quality system works as intended, focusing testing effort where risk is highest.

The traditional, document-heavy approach to demonstrating that a computerized system performs as intended, typically through extensive scripted test protocols.

The completeness, consistency, and accuracy of data throughout its lifecycle, from creation to retention or deletion.

Any combination of text, graphics, data, audio, or other information in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.

A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of a handwritten signature.

A formal notice FDA issues to a company after an inspection finds significant regulatory violations, describing the violations and requiring corrective action.

A general term for the "Good Practice" quality guidelines and regulations across regulated industries (e.g. GMP, GLP, GCP, GDP).

An international guideline providing a framework for the assessment and control of DNA-reactive (mutagenic) impurities in pharmaceuticals, to limit potential carcinogenic risk.

The state of being able to promptly produce evidence — validation records, audit trails, change history, CAPA records — that demonstrates control over a regulated system or process.

The specific purpose a system, process, or product is meant to serve, which determines the scope and depth of validation or assurance evidence that is actually needed.

A class of DNA-reactive (mutagenic) impurities that can form in pharmaceuticals under certain manufacturing, formulation, or storage conditions.

An approach that scales the depth and rigor of validation evidence to the actual risk a system poses to product quality, patient safety, or record integrity — rather than applying uniform, maximum rigor everywhere.

Software hosted and operated by a vendor and accessed by customers over the internet, typically updated continuously by the vendor rather than installed and version-locked by the customer.