Audit
Definition of the term ("What is an audit?") An audit checks whether requirements, processes and guidelines comply with required standards or norms. Due to the high significance of quality, audits…
CAPA (Corrective and Preventive Action)
Definition of the term ("What is CAPA?") CAPA (Corrective and Preventive Action) is a process within the quality management system (QMS) and a component of GMP-compliant work. In this case, errors or…
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 action
Definition of the term ("What is a corrective action?") In ISO 9000, a corrective action is described as "action taken to eliminate the cause of a detected error or other…
Device Master Record (DMR)
Definition of the term ("What is a Device Master Record?") A Device Master Record is a technical product file with a compilation of documents and records containing all specifications and…
Document Management System (DMS)
Definition of the term ("What is a Document management system (DMS)?" A document management system (DMS) can be understood as the management of electronic documents in a database. In the…
eDMS
Definition of the term ("What is an eDMS?") An electronic document management system, abbreviated eDMS, is a software solution for storing, organizing, retrieving and managing electronic documents and images. It…
Enterprise Content Management System (ECM)
Definition of the term ("What is ECM?") Enterprise Content Management, often abbreviated as ECM, is a robust and integrated set of processes and technologies designed to capture, manage, store, preserve,…
EU GMP guideline
Definition of the term ("What is the EU GMP Guideline?") The EU GMP Guideline, or the "EU Good Manufacturing Practice" Guideline, is a comprehensive set of rules developed by the…
EU GMP Guideline Annex 11
Definition of the term ("What is the EU GMP Guidance Annex-11?") Annex-11 of the EU GMP Guideline is specific to computerized systems and electronic records. It was developed to ensure…
EU GMP Guidelines Chapter 4
Definition of the term ("What is Chapter 4 of the EU GMP Guide?") Chapter 4 of the EU GMP Guide focuses on documentation and records in pharmaceutical production. This section…
EU GMP Guidelines Chapter 7
Definition of the term ("What is Chapter 7 of the EU GMP Guide?") The EU GMP Guidance, Chapter 7 is a key part of the EU regulatory framework for pharmaceutical…
FDA 21 CFR Part 11
Definition of the term ("What is FDA 21 CFR Part 11?") FDA 21 CFR Part 11 is a set of regulations introduced by the US Food and Drug Administration (FDA) in…
GAMP5
Definition of the term ("What is the GAMP5?") The GAMP5 is a set of guidelines and best practices developed by the International Society for Pharmaceutical Engineering (ISPE) to ensure the…
GMP
Definition of the term ("What is GMP?") GMP stands for "Good Manufacturing Practice". Thus, GMP includes guidelines and regulations that must always be followed when companies are involved in the…
GxP
Definition of the term ("What is GxP?") GxP, short for "Good Practices," is a collective term that encompasses various regulations, standards and guidelines that control the quality and compliance of…
IQ (Installation Qualification)
Definition of the term ("What is the installation qualification?") The installation qualification, also known as IQ, is a process of verifying that all solutions, equipment and plants in a production…
ISO 13485:2016
Definition of the term ("What is ISO 13485:2016?") ISO 13485:2016 is an internationally recognized standard developed specifically for the medical device industry. It sets out the requirements for a quality…
ISO 9001:2015
Definition of the term ("What is ISO 9001:2015?") ISO 9001:2015 is an international standard for quality management systems. It specifies the requirements that an organization must meet in order to…
ISO certification
Definition of the term ("What does ISO certification mean?") The ISO certification is a procedure that serves the purpose of demonstrating compliance with certain requirements. For example, ISO 9001 specifies…
Medical Device Regulation (MDR)
Medical Device Regulation (MDR) - Regulation 2017/745 (EU) on medical devices The German equivalent for the term Medical Device Regulation (MDR) is "Medical Device Regulation". The European Union (EU) Regulation 2017/745 will…
Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (“Arzneimittel- und Wirkstoffherstellungsverordnung — AMWHV”, section 2, §10, §20)
Definition of the term ("What is the Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients?") The Ordinance on the Production of Medicinal Products and Active Pharmaceutical Ingredients…
Personnel file (digital)
Definition of the term ("What is a digital personnel file?") The digital personnel file, also known as an e-file or digital employee file, is a software solution for managing and storing…
PQ (Performance Qualification)
Definition of the term ("What is a Performance Qualification?") In the world of pharmaceutical manufacturing and quality assurance, performance qualification (PQ) is a critical step in ensuring that equipment and…
Preventive actions
Definition of the term ("What are preventive actions?") In ISO 9000, a preventive action is described as an "action to eliminate the cause of a possible error or other possible…
Process audit
Definition of the term ("What is a process audit?") A process audit is a systematic approach to reviewing and evaluating business processes in an organization. The aim is to ensure…
Quality management handbook
Definition of the term („What is a quality management handbook?“) The quality management manual serves as an internal compilation and record of the quality management system of a company. It…
Quality Management Representative (QMR)
Definition of the term ("What is a quality management representative?") The role of the Quality Management Representative (QMR) in a company is of critical significance in ensuring the quality of…
Specification
Definition of the term ("What is a specification?") A specification contains a specified description by the contractor of how they intends to solve the contracting entity's requirements. As a preceding…
Standard Operating Procedure (SOP)
Definition of the term ("What is an SOP?") Standard operating procedures (SOPs) are written documents that provide detailed instructions for specific work processes in a company or organization. These instructions…
User Requirement Specification (URS)
Definition of the term ("What is a specification?") In the world of project management and software development, the user requirement specification (URS) plays a central role. This comprehensive document serves…
Validation
Definition of the term ("What does validation mean?") Validation plays a special role in all regulations of the GxP environment. Fundamentally, the validation means providing a documented proof that a…
WHO guidance on good data and record management practices
Definition of the term ("What is the WHO Good Practice Guideline for Data and Records Management?") The WHO Good Practice Guideline for Data and Records Management is of utmost significance…