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

Your path to digitalization

- find the right solution

Our di­gi­ta­liza­ti­on so­lu­ti­ons pri­ma­ri­ly ad­dress do­cu­ment-ba­sed pro­ces­ses in ma­nu­fac­tu­ring, pro­duc­tion and qua­li­ty ma­nage­ment. For more in­for­ma­ti­on about our so­lu­ti­ons, click here.

To the so­lu­ti­on overview
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Mapping of the electronic quality management tile from our document management system
Illustration of the supplier qualification tile
Abbildung der Kachel Vertragsmanagement
Illustration of the technical documentation tile from our document management system
Abbildung der Kachel Complaint
Abbildung der Kachel Deviation Control
Abbildung der Kachel CAPA
Abbildung der Kachel Change Control
Illustration of the document control tile from our document management system
Mapping the Training Management tile of our document management system
Abbildung der Kachel E-Learning
Mapping the contract management tile of our document management system
Illustration of the scanning and classification tile from our document management system
Mapping of the incoming invoice processing tile from our document management system
Illustration of the tile Audit-proof archive / Structured workflows
Mapping of the d.velop documents (formerly d.3ecm) tile from d.velop from our document management system

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