# Your portal for pharmaceutical and biotech terminology

> On info-pharma.de, our young team collects definitions and technical terms relating to pharma, biotech and clinical trials to help newcomers to the field get off to a quick start.

- Source: https://info-pharma.de/en/
- Language: English (UK)

---

On info-pharma.de, our young team collects definitions and technical terms relating to [pharma](https://info-pharma.de/en/pharmazie/), [biotech](https://info-pharma.de/en/biotech/) and clinical trials to help newcomers to the field get off to a quick start. With our information site, we want to help interested readers gain a quick insight into this subject area and, above all, provide an overview of the specific terminology used in the pharmaceutical and biotech industry.

## Fundamentals
- [Pharmacy](https://info-pharma.de/en/pharmazie/index.html.md): Pharmacy deals with the composition, effect, development, testing, manufacture and dispensing of medicinal products.
- [Biotechnology](https://info-pharma.de/en/biotech/index.html.md): Biotechnology is the technical use of enzymes, cells and complex organisms in the manufacture of medicines.

## Regulatory requirements
- [Regulatory requirements for the approval of medicines](https://info-pharma.de/en/regulatorische-anforderungen/index.html.md): In both the pharmaceutical and the biotech industry, the approval of a medicine is subject to strict regulatory requirements.
- [What is meant by GxP?](https://info-pharma.de/en/gxp/index.html.md): In both the pharmaceutical and the biotech industry, the approval of a medicine is subject to strict GxP requirements.
- [What is Good Laboratory Practice?](https://info-pharma.de/en/glp/index.html.md): The term Good Laboratory Practice (GLP) describes the formal framework for conducting safety studies.
- [What is Good Manufacturing Practice?](https://info-pharma.de/en/gmp/index.html.md): The term Good Manufacturing Practice (GMP) covers various guidelines for production processes and environments.
- [GCP: What Good Clinical Practice Means and How Software Supports Compliance](https://info-pharma.de/en/gcp/index.html.md): Good Clinical Practice explained: aims, history, ICH E6(R3) with effective dates in the EU, US and UK, legal framework, roles, inspection findings and software-supported compliance.
- [21 CFR Part 11 and Electronic Signatures: Requirements, Scope and Implementation](https://info-pharma.de/en/21-cfr-part-11/index.html.md): 21 CFR Part 11 explained: scope, requirements for electronic records and signatures, clinical investigations, comparison with EU GMP Annex 11 and eIDAS, typical findings.
- [Computer System Validation (CSV): Fundamentals, Regulatory Requirements and Validation of Cloud Software in the GxP Environment](https://info-pharma.de/en/computer-system-validation/index.html.md): Computer system validation in GxP: Annex 11, 21 CFR Part 11, GAMP 5, CSA, the validation lifecycle, cloud and SaaS validation, pre-validated software and inspection findings. Status November 2026.
- [Data Integrity and ALCOA+: Principles, Regulatory Requirements and Implementation in the GxP Environment](https://info-pharma.de/en/alcoa-datenintegritaet/index.html.md): Data integrity and ALCOA+ explained: ALCOA, ALCOA+ and ALCOA++ compared, FDA, MHRA, PIC/S, WHO and EMA expectations, electronic systems and typical findings.

## Organisation & systems
- [Outsourcing or decentralisation](https://info-pharma.de/en/outsourcing-dezentralisierung/index.html.md): The term outsourcing can be understood as a business strategy in which individual processes of a company are outsourced.
- [CRO Sponsor Oversight: How Sponsors Ensure Oversight of Outsourced Trial Activities](https://info-pharma.de/en/cro-sponsor-oversight/index.html.md): Sponsor oversight of CROs: ICH E6(R3), EU Regulation 536/2014, 21 CFR 312.52, TORO, oversight plans, KPIs, audits, inspection findings and practical advice for small sponsors. Status November 2026.
- [Document Management Systems](https://info-pharma.de/en/dokumentenmanagementsysteme/index.html.md): The term document management system describes database-supported software whose aim is to support internal document management.
- [Unsuitable Document Management Systems in the Pharmaceutical and Biotech Industry](https://info-pharma.de/en/ungeeignete-dokumentenmanagementsysteme-pharma-biotech/index.html.md): Companies repeatedly decide to introduce Microsoft SharePoint as their DMS. But is that a good decision?
- [TMF and eTMF: What the Trial Master File Is and Which Requirements Apply to Keeping It Electronically](https://info-pharma.de/en/tmf-etmf/index.html.md): Trial master file and eTMF: definition, legal basis (EU CTR, EMA guideline, ICH E6(R3), 21 CFR 312), TMF Reference Model, eTMF requirements and inspection findings.
- [GxP Document Control and Good Documentation Practice: Requirements for the Life Cycle of Controlled Documents](https://info-pharma.de/en/gxp-dokumentenlenkung/index.html.md): GxP document control and Good Documentation Practice: regulations, document hierarchy, life cycle of controlled documents, GDocP rules, eDMS and inspection findings.