Audit
Definition of the term ("What is an audit?") An audit checks, if the requirements, processes, and guidelines meet prescribed standards or norms. Due to the high significance of quality, audits…
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Audit
CAPA (Corrective and Preventive Action)
Definition of the term (“What is CAPA?”) A CAPA (Corrective and Preventive Action) is a measure within the quality management system (QMS) and is part of GMP compliant operations. This analyzes actual…
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CAPA (Corrective and Preventive Action)
Complaint management
Definition of the term („What is a complaint?“) A complaint management includes all measures taken by a company to process customer complaints about the company’s performance. The emphasis lies on…
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Complaint management
Corrective Actions
Definition of the term („What is a corrective action?“)The ISO 9000 describes a corrective action as a “measure to eliminate the cause of a detected fault or another undesirable situation”.…
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Corrective Actions
Device Master Record (DMR)
Definition of the term („Was is a Device Master Record?“) A Device Master Record is a technical product file with compilation of records which includes the processes and specifications for…
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Device Master Record (DMR)
Document Management System (DMS)
Definition of the term ("What is DMS?") A document management system (DMS) can be understood as the management of electronic documents in a database. In the DACH region, it is…
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Document Management System (DMS)
Enterprise Content Management System (ECM)
Definition of the term ("What is ECM?") ECM is the abbreviation of Enterprise Content Management. This is the management of all data and information generated in an organization. ECM is…
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Enterprise Content Management System (ECM)
EU GMP guideline
The EU GMP guideline summarizes all regulations and operating instructions that have ever been specified for pharmaceutical companies in the Federal Republic of Germany. This guideline and all it annexes…
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EU GMP guideline
EU GMP Guideline Annex 11
Annex 11 of EU GMP guideline. It describes requirements for all kinds of computerized systems used as part of GMP-regulated activities.A computer-based system is a combination of software and hardware…
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EU GMP Guideline Annex 11