Industry & Applied R&D
Contract Research Organisations
Organisations conducting research under contract to sponsors, spanning preclinical CROs, clinical CROs, and analytical testing laboratories. Distinctive for sponsor-oversight obligations, audit readiness as a standing operational requirement, and quality systems built around demonstrable regulatory compliance.
8 pages across 3 topic areas
Laboratory Compliance & Quality
- Document Control Procedure: The Six-Stage Lifecycle
How a document control procedure governs draft, review, approval, distribution, revision, and withdrawal for controlled documents in a GxP quality sys…
- ICH E6(R3) Definitions: Audit, Inspection, Monitoring and Quality Assurance
What ICH E6(R3) actually says an audit, an inspection, monitoring and quality assurance are — each definition quoted verbatim from the Step 4 Glossary…
- Validation Master Plan (VMP) for a Regulated Laboratory: Scope, System Inventory, and Periodic Review
A validation master plan is the governing document above individual qualification exercises. This guide applies EU GMP Annex 15 and Annex 11 to a regu…
- GxP Compliance: What GLP, GCP, GMP, and GDP Actually Require
GxP is an umbrella term for GLP, GCP, GMP, GDP, and related “Good … Practice” frameworks. This guide explains what they share, which one applies to wh…
- Computer System Validation (CSV): GAMP 5, IQ/OQ/PQ, and 21 CFR Part 11
What computer system validation actually requires for regulated laboratory systems: the GAMP 5 risk-based approach, GAMP software categories and the c…
- ISO/IEC 17025: What It Actually Accredits and How It Differs from ISO 9001
ISO/IEC 17025:2017 accredits a laboratory’s technical competence for a defined scope of tests or calibrations — it does not certify the organization a…
Clinical Research Administration
- Regulatory Intelligence: Building a Monitoring Function
A source taxonomy, monitoring mechanics, and a five-stage triage workflow for building a regulatory intelligence function that feeds submission strate…
Research Tools & Software
- What Is a LIMS? Laboratory Information Management System Explained
A Laboratory Information Management System (LIMS) tracks lab samples, workflows, and results with a full audit trail. This guide explains what a LIMS …
