Glossary — eDHR, BMR, MMR, 21 CFR Part 11, FSMA 204 & more | V5 Ultimate

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Glossary

Regulated manufacturing, decoded.

Every acronym a regulator, customer or auditor might throw at you — eBMR, eDHR, MMR, 21 CFR Part 11, FSMA 204, GAMP 5, UDI, MoCRA, HACCP — defined in plain English, tagged to the industries it touches, and linked into the V5 capabilities that handle it.

#A B C D E F G H I K L M N O P Q R S T U W

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— FDA cGMP for PET drugs

FDA cGMP rule for Positron Emission Tomography (PET) drugs — short half-life specific.

FDA rule that defines when electronic records and e-signatures are trustworthy enough to replace paper.

A

Tamper-evident log of who changed what, when, and why — required by Part 11.

B

— Batch (production) record

Generic term for the per-batch evidence document — called BMR in pharma, BPR in supplements, DHR in medical devices.

— Batch Manufacturing Record

The signed record proving one specific batch was made exactly to the approved Master Manufacturing Record.

— Batch Production Record

FDA dietary-supplement equivalent of a BMR — the per-batch evidence under 21 CFR 111.

— Brand Reputation Compliance Global Standards

GFSI-recognised food-safety standard — most common in UK and EU food retailing.

C

— Corrective Action and Preventive Action

Structured investigation + fix loop for recurring problems — required by every quality regime.

— Critical Control Point

A step in a food process where control is essential to prevent or eliminate a safety hazard.

— Certificate of Analysis

Lab-signed proof that a specific lot of material met its specification.

— Certificate of Conformance

Vendor statement that a product meets the agreed specification — lighter than a CoA.

Conditional release

Releasing a batch before all tests are complete — only permitted under specific rules (e.g. PET drugs).

— Computer Software Assurance

FDA's lighter-touch successor to CSV — risk-based, evidence-focused, less documentation.

— Computer System Validation

The formal process of proving a software system does what it should, reliably and predictably.

— Critical Tracking Event

FSMA 204 — the points in your supply chain where lot history must be captured.

Inventory & traceability

D

ALCOA+ — data must be Attributable, Legible, Contemporaneous, Original, Accurate (+ Complete, Consistent, Enduring, Available).

Approved exception from the procedure — investigated, justified, and signed off.

— Design History File

The complete design-and-development history of a medical device — required for 510(k) and audits.

— Device History Record

Per-unit evidence that one specific medical device was built to its approved DMR.

— Device Master Record

The approved master spec for a medical device — what every DHR must reproduce.

— Drug Supply Chain Security Act

US law requiring item-level serialisation and electronic traceability across the Rx drug supply chain.

Inventory & traceability

E

Cryptographic substitute for a wet signature, with re-authentication and meaning bound to the record.

— Electronic Batch Manufacturing Record

A BMR captured electronically with audit trail and e-signatures instead of paper.

— Electronic Device History Record

Electronic, Part 11-compliant DHR — built as the device is built, not retyped after.

— Electronic Data Interchange 856 (Advance Ship Notice)

Electronic 'heads-up' to the retailer telling them what's on the truck before it arrives.

Inventory & traceability

— Enterprise Resource Planning

Finance, purchasing, sales, high-level inventory. V5 extends ERP down to the shop floor — no rip-and-replace.

Systems & integration

European equivalent of 21 CFR Part 11 — rules for computerised systems in GMP.

F

— First Expired, First Out

Pick the lot with the soonest expiry first — the rule for any perishable or shelf-life-bound material.

Inventory & traceability

— First In, First Out

Pick the oldest received lot first — used when shelf life isn't the binding constraint.

Inventory & traceability

— FDA Food Safety Modernization Act, Section 204

FDA rule requiring electronic 24-hour traceability for foods on the Food Traceability List.

Inventory & traceability

GFSI-recognised food-safety standard combining ISO 22000, PRP and additional requirements.

G

— Good Automated Manufacturing Practice (v5)

ISPE's risk-based framework for validating computerised systems in regulated industries.

— Global Food Safety Initiative

The umbrella body that benchmarks food-safety standards (SQF, BRCGS, FSSC 22000, IFS).

Barcode standard that encodes lot, expiry, qty and GTIN in one scan — the foundation of license-plate inventory.

Inventory & traceability

— Global Trade Item Number

GS1's globally unique product identifier — the 'product' part of every retail barcode.

Inventory & traceability

Umbrella term — GMP (manufacturing), GLP (lab), GCP (clinical), GDP (distribution).

H

— Hazard Analysis and Critical Control Points

Food-safety framework that identifies hazards and the critical points where they must be controlled.

I

— Installation / Operational / Performance Qualification

The three qualification stages that prove a system is installed, operating, and performing as intended.

International QMS standard for medical-device manufacturers — recognised globally.

Generic international QMS standard — the foundation almost every industry-specific standard builds on.

K

— Key Data Element

FSMA 204 — the specific data points you must capture at each tracking event.

Inventory & traceability

L

— Laboratory Information Management System

Lab-side system that owns samples, instruments, methods, results, OOS, CoA.

M

— Manufacturing Execution System

The system that runs the shop floor — work orders, dispense, weigh, blend, package, label.

Systems & integration

— Master Manufacturing Record

The approved master recipe and process every batch must reproduce exactly.

— Modernization of Cosmetics Regulation Act

2022 US law that put cosmetics under FDA oversight — facility registration, product listings, adverse-event reporting.

— Safety Data Sheet (formerly MSDS)

Standardised 16-section hazard document required for every hazardous chemical (OSHA HazCom 2012 / GHS).

N

— Non-Conformance Report

Formal record of something out-of-spec — material, process, product or document.

O

— Overall Equipment Effectiveness

Availability × Performance × Quality — the standard line/asset productivity metric.

— Out Of Specification

Lab result that fails its acceptance spec — triggers a regulated investigation.

— Out Of Trend

Lab result inside spec but drifting — early warning of process drift.

P

— Product Information File

EU cosmetic regulation requirement — the dossier the Responsible Person must keep for every product.

Q

— Quality Management System

Audits, NCR/CAPA, deviations, complaints, supplier quality, document control.

Systems & integration

— Qualified Person release

EU GMP — only a named Qualified Person can certify a batch for market release.

R

— NRC Regulatory Guide 1.86

NRC limits for releasing radioactive materials from licensed sites — surface ≤ 2× background, removable ≤ 1000 dpm/100cm².

S

— Standard Operating Procedure

Controlled procedure document — versioned, reviewed, training-acknowledged.

— Statistical Process Control

Charts that detect process drift before it becomes a failure — Shewhart, CUSUM, EWMA.

— Safe Quality Food

GFSI-recognised food-safety standard widely used in the US — SQFI runs the program.

— Serial Shipping Container Code

GS1's 18-digit unique pallet ID — one SSCC per outbound pallet for EDI 856 ASN.

Inventory & traceability

T

Training record

Per-person evidence that an operator has been trained on the current version of every SOP they execute.

Two-person e-signature

Preparer + independent reviewer — required for MMRs and many GMP approvals.

U

— Unique Device Identification

FDA-mandated unique ID on every medical device — submitted to GUDID.

Inventory & traceability

W

— Warehouse Management System

Receiving, putaway, lots/serials, bins, transfers, picking, shipping — the inventory layer.

Systems & integration