Validation capabilities.
VLMcare supports the full validation lifecycle for GxP-regulated operations. Below is the scope buyers, auditors, and IT teams ask about.
Computer System Validation (CSV)
Validate computerised systems under 21 CFR Part 11 and EU Annex 11.
Part 11 readyComputer Software Assurance (CSA)
Risk-based assurance aligned with FDA guidance.
Part 11 readyEquipment Qualification (IQ, OQ, PQ)
Installation, operational, and performance qualification with linked traceability.
Part 11 readyProcess Validation
Process design, performance qualification, and continued process verification.
Part 11 readyCleaning and Equipment Validation
Sampling plans, recovery studies, and validation reporting.
Part 11 readyPeriodic Review and Revalidation
Scheduled reviews, change control links, and inspection-ready records.
Part 11 readyCommissioning, Qualification & Validation (CQV)
End-to-end CQV for equipment, utilities, and facilities.
Part 11 readyIT Infrastructure Qualification
Qualify servers, networks, and cloud infrastructure under GxP.
Part 11 readyCSV vs CQV: what is the difference?
Computer System Validation (CSV) proves that a computerised system does what it is specified to do and keeps electronic records trustworthy. Its scope is software: user requirements, configuration, functional testing, data integrity, and 21 CFR Part 11 controls.
Commissioning, Qualification and Validation (CQV) proves that physical assets — equipment, utilities, and facilities — are installed and perform as intended. Its scope is hardware and process: commissioning, IQ, OQ, PQ, and handover to operations.
The two overlap where a system controls an asset. A packaging line has CQV for the machine and CSV for its control software. VLMcare governs both in one system, so requirements, tests, and evidence trace across the software and the asset without duplicate records.
Reviewed by the VLMcare validation team · Last reviewed August 2026