Glossary
The 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
- Audit
- CAPA (Corrective and Preventive Action)
- Complaint management
- Corrective action
- Device Master Record (DMR)
- Document Management System (DMS)
- eDMS
- Enterprise Content Management System (ECM)
- EU GMP guideline
- EU GMP Guideline Annex 11
- EU GMP Guidelines Chapter 4
- EU GMP Guidelines Chapter 7
- FDA 21 CFR Part 11
- GAMP5
- GMP
- GxP
- IQ (Installation Qualification)
- ISO 13485:2016
- ISO 9001:2015
- ISO certification
- Medical Device Regulation (MDR)
- Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (“Arzneimittel- und Wirkstoffherstellungsverordnung — AMWHV”, section 2, §10, §20)
- Personnel file (digital)
- PQ (Performance Qualification)
- Preventive actions
- Process audit
- Quality management handbook
- Quality Management Representative (QMR)
- Specification
- Standard Operating Procedure (SOP)
- User Requirement Specification (URS)
- Validation
- WHO guidance on good data and record management practices
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