Glossary

21 CFR Part 11 (ER/ES)

The FDA regulation defining the criteria for trustworthy, reliable electronic records and signatures equivalent to paper.

Change cycle time

Time span between initiating a process or recipe change and its productive, validated deployment.

Audit trail

A tamper-evident event log in a GxP-relevant system that records creation, changes, approvals and access with timestamp, user identity and—where required—justification.

Compliance by Design

An approach in which regulatory requirements are integrated into processes, system architecture and workflows from the outset instead of being added later

Computer System Validation (CSV)

A documented process that demonstrates in a traceable, consistent and repeatable way that a computerized system fulfils its intended purpose

Delta validation

Validation approach where only the changed portion (delta) of a digitized process / recipe is assessed and documented – not the entire chain.

Digital bottleneck

A state where a monolithic or rigid digital platform (e.g. legacy MES/EBR) becomes the dominant rate-limiting factor for process change and innovation.

GAMP 5

The ISPE guide to a risk-based lifecycle for GxP-relevant computerized systems.

Golden cage

Metaphor for an expensive enterprise system that delivers perceived control & compliance while constraining flexibility, change autonomy and domain ownership.

IQ/OQ/PQ

Documented qualification stages for installation, operation in line with specifications, and performance in intended use.

Master Batch Record (MBR)

The approved master template for manufacturing a batch, defining steps, parameters, limits and control rules.

Review by Exception

A risk-based approach to batch record review in which a validated system checks defined rules and QA/QP assess quality-relevant exceptions

Word-native EBR

Approach to creating electronic batch records directly from existing Microsoft Word® recipe or SOP documents, enriched with Word® standard elements.