Glossary
Core terms related to agile GxP manufacturing, electronic batch records and enablement-driven digital transformation.
Choose a term:
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 deletions 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
Risk-based change validation
Risk-based approach where, after a change to a digitized process / recipe, only what is affected is assessed and documented – not the entire system. Also known as delta validation.
Digital bottleneck
A state where a monolithic or cumbersome digital system (e.g. a rigid eBR/MES) 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 supports control & compliance but can constrain flexibility, ability to change 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-based eBR
Approach (also known as “Word-native eBR”) to creating electronic batch records directly from existing recipes or SOPs in Microsoft Word®, enriched with structured standard elements.