GxP glossary by Digital Life Sciences

Definitions on topics related to GxP, quality assurance, and document and quality management. Are you interested in further explanations of terms related to GxP and our products? Then use our glossary here.

Glossary contribution on the topic of audit

Audit

CAPA (Corrective and Preventive Action)
Glossary contribution on the topic of complaints management

Complaints management
Glossary contribution on the topic of corrective measures

Corrective action

Device Master Record (DMR)
Glossary contribution on the topic of document management

Document management
Glossary contribution on the topic of DMS

Document Management System (DMS)

eDMS
Glossary contribution on the topic of ECM

Enterprise Content Management System (ECM)
Glossary contribution on the topic of EU GMP guidelines

EU GMP guideline

EU GMP Guideline Annex 11
Glossary contribution on the topic of EU GMP Chapter 4

EU GMP Guidelines Chapter 4
Glossary contribution on the topic of EU GMP Chapter 7

EU GMP Guidelines Chapter 7

FDA 21 CFR Part 11
Glossary contribution on the topic of functional specifications

Functional specification
Glossary contribution on the subject of Gamp5

GAMP5

GMP

GxP
Glossary contribution on the subject of IQ

IQ (Installation Qualification)

ISO 13485:2016
Glossary contribution on the subject of ISO 9001

ISO 9001:2015
Glossary article on the topic of ISO certification

ISO certification
Glossary contribution on the topic of MDR

Medical Device Regulation (MDR)
Glossary contribution on the topic of AMWHV

Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (“Arzneimittel- und Wirkstoffherstellungsverordnung – AMWHV”, section 2, §10, §20)
Glossary contribution on the topic of PQ

PQ (engl. Performance Qualification)
Glossary contribution on the topic of preventive measures

Preventive actions
Glossary contribution on the topic of process audits

Process audit
Glossary contribution on the topic of QMH

QM handbook (QMH)
Glossary contribution on the topic of QMR

Quality Management Representative (QMR)
Glossary contribution on the topic of software validation

Software validation
Glossary contribution on the topic of SOP

Standard Operating Procedure (SOP)
Glossary contribution on the subject of specifications

User Requirement Specification (URS)
Glossary contribution on the topic of validation

Validation
Glossary contribution on the WHO guideline

WHO Good Practice Guideline for Data and Records Management

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Image of the tile Electronic Quality Management of our document management system
Image of the tile Supplier Qualification
Image of the tile Reporting of our document management system
Image of the tile Technical Documentation of our document management system
Image of the tile Complaint of our document management system
Image of the tile Deviation Control of our document management system
Image of the tile CAPA of our document management system
Image of the tile Change Control of our document management system
Image of the tile Document Control of our document management system
Image of the tile Training Management of our document management system
Image of the tile e-learning of our document management system
Image of the tile Contract management of our document management system
Image of the tile Scanning and Classification of our document management system
Image of the tile Incoming invoice processing of our document management system
Image of the tile Audit-compliant archive / Structured workflows from our document management system
Image of the tile d.velop documents (formerly d.3ecm) from d.velop of our document management system

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