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Quality & Compliance

Computer System Validation (CSV).

We support pharmaceutical, biotech, and medtech companies in the comprehensive validation of computer-based systems—from LIMS and ERP to MES and QMS software—in accordance with GAMP5 and Annex 11.

CSV team tests mainframe system in the data center

What is Computer System Validation (CSV)? Computer System Validation (CSV) is the documented evidence that a computer-based system reliably and reproducibly fulfills its intended purpose in a GxP-regulated environment. It encompasses validation planning, risk analysis, IQ/OQ/PQ qualification, and continuous lifecycle management in accordance with GAMP 5, EU GMP Annex 11, and FDA 21 CFR Part 11.

How do pharmaceutical companies validate computer-based systems in accordance with GAMP5?

EU GMP Annex 11 and FDA 21 CFR Part 11 set forth clear requirements for IT systems. This often leads to the following pitfalls:

  • Systems are implemented without complete validation documentation—an inspection finding is inevitable.
  • Validation packages (URS, FS, IQ, OQ, PQ) are incomplete or do not comply with the current GAMP5 standards.
  • Software updates and system upgrades are performed without a dedicated change management process.
  • Data integrity (audit trail, access control, electronic signatures) has not been fully implemented.
Are all of your GMP-critical IT systems fully validated and up to date with GAMP5 requirements?
Quality engineer reviews validation protocol

Our CSV services.

We validate computer-based systems efficiently, in a manner that stands up to scrutiny, and using a consistently risk-based approach.

Risk-based validation strategy (GAMP5)
Classification of your systems according to GAMP5 categories (1–5). Development of a risk-based strategy to reduce unnecessary validation efforts without compromising compliance.
Complete CSV documentation
Preparation of all validation documents, from the URS through functional specifications, traceability matrices, IQ, OQ, and PQ protocols, test scripts, to the final validation report (Annex 11).
Data Integrity & Audit Trail Assessment
Review and implementation of data integrity requirements: audit trails, access permissions, and electronic signatures in accordance with 21 CFR Part 11 and EMA guidelines.
Change Control & Revalidation
Post-Implementation Management: Impact assessment for software updates, OS upgrades, and hardware changes. Planning and execution of the appropriate revalidation.

How does a CSV with ENTOURAGE work?

Risk-based approach according to GAMP 5 — in 5 structured phases.

01

System Assessment

Classify the system (GAMP category), identify regulatory requirements, and define the scope of validation.

02

Validation Plan

V-Model-based plan including URS, FS, and DS. Define risk analysis and test strategy.

03

Qualification

Perform IQ, OQ, and PQ. Create, execute, and document test scripts.

04

Validation Report

Summarize results, evaluate discrepancies, and prepare a validation report.

05

Lifecycle

Change control, periodic reviews, and revalidation during system updates.

QM
“CSV is no longer the 500-page paper monster it used to be. With CSA and risk-based testing, we’re reducing the workload by up to 40 percent—without compromising compliance.”
CSV/CSA Team, ENTOURAGE

Frequently Asked Questions About Computer System Validation.

What is GAMP5, and what does it mean in practice?
GAMP5 (Good Automated Manufacturing Practice) is the industry guideline for the validation of computer-based systems. It defines a risk-based framework: less effort for non-critical systems, more for GMP-critical applications.
Which systems need to be validated?
All systems that generate, process, or store GMP-relevant data: LIMS, ERP (for GMP functions), MES, eQMS, DMS, laboratory systems, and control systems (SCADA/PLC).
What is the difference between IQ, OQ, and PQ in CSV?
IQ confirms that the system is installed correctly. OQ confirms that the system functions as specified (limit values, error messages). PQ confirms that the system operates as intended in the business department’s actual process.
Do I need to revalidate after every software update?
Not necessarily. First, an impact assessment is required: Which functions are affected? Based on this, the scope of the required revalidation is determined—ranging from no revalidation to a full OQ/PQ.
What is the difference between CSV and CSA?
CSV (Computer System Validation) is the traditional, document-heavy approach. CSA (Computer Software Assurance) is the more modern, risk-based approach in accordance with the FDA’s 2022 Draft Guidance. CSA reduces the testing effort for low-risk systems and focuses critical testing on high-risk functions.
Which systems need to be validated?
All GxP-relevant systems: ERP, LIMS, eQMS, MES, chromatography software, electronic batch records, and clinical databases. SaaS solutions and cloud systems are also subject to validation requirements.

Additional expertise in the area of Quality & Compliance.

Expertise

Digitalization

Successfully implementing the digital transformation of processes in a highly regulated environment.

 Expertise

ERP integration

Validate ERP systems such as SAP for GMP compliance and integrate them seamlessly into production.

 Expertise

IT System Audits

Audits to assess the quality, validation, and compliance of your IT systems.

Validate IT systems securely and manage updates effectively.

We handle the entire CSV planning process, from URS to PQ, and ensure that your systems comply with current GAMP5 requirements.

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