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 ...

CAPA

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 ...

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 ...

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 ...

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 ...

Digital Personnel File

Definition of the term („What is a Digital Personnel File?“) The digital personnel file is a software solution used to manage staff-related documents. It contains scanned documents as well as ...

Document Management System (DMS)

Definition of the term („What is a DMS?“) A docuemnt management system (DMS) can be understood as the management of of electronic documents in a database. In the DACH region, ...

eDMS

Electronic document management system

Enterprise Content Management System (ECM)

Definition of the term („What is an ECM?“) ECM is the abbreviation of Enterprise Content Management. This is the management of all data and information generated in an organization. ECM ...