Computer System Validation (CSV) in Pharma Explained

Pharmaceutical manufacturers, biotech firms, and quality assurance teams in London face increasing pressure from regulators like the MHRA, EMA, and FDA to maintain strong control over computerized systems. Electronic systems, from LIMS and MES to document management and ERP platforms, play a central role in production, quality control, and distribution. If they are not validated, those systems can become liabilities rather than assets. That’s where Computer System Validation Services from Inglasia come in.

Our validation approach ensures that your software and infrastructure work precisely as intended, are fully documented, and remain inspection-ready over the entire system lifecycle. We help you avoid regulatory gaps, data integrity risks, and costly deviations so you can protect both patient safety and compliance.

Why Validation of Computer Systems Is Critical in Pharma

Modern pharma operations rely on digital systems to gather critical data, execute processes, and maintain traceable records. If these systems are not validated, you risk:

Failing audits because you cannot provide documented proof that systems perform consistently.
Data integrity issues: Without validation, you cannot guarantee that records are accurate, complete, or secure.
Regulatory noncompliance: Regulators such as the MHRA expect firms to follow good practices like GAMP 5.
Operational disruption: An unvalidated system can lead to production delays, batch failures, or system downtime.
Patient safety risk: Poor system control undermines the trustworthiness of quality data.

By engaging professional Computer System Validation Services, you reduce inspection risk, increase system stability, and maintain long-term compliance.

Our Computer System Validation Services

Inglasia’s CSV offering in London is not “one size fits all.” We tailor our validation services using a risk-informed, lifecycle-based approach derived from GAMP 5 principles.

Here is how we support your validation journey:

Validation Planning & Strategy

We start by assessing your computerised systems, classifying them according to risk and GxP impact, and then creating a validation master plan. This includes defining the boundaries of validation, establishing roles and responsibilities, and setting timelines and deliverables. We use our “Seven Pillars of Quality” to build trust, align with your team, and drive consistent outcomes.

Requirements Definition & Traceability

In this stage, we help you define user requirement specifications (URS), functional requirement specifications (FRS), and map them into a traceability matrix. This ensures that all critical functions are tested and traced back to user needs. Poor requirement definition and missing traceability are common causes of audit observations.

Qualification Testing (IQ / OQ / PQ)

We develop and execute your IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols. Our test scripts cover edge conditions, error handling, user access, backup, and recovery procedures to reflect real-world processes.

Validation Documentation & Reporting

All validation activities come with full, audit-ready documentation. We deliver protocol templates, test reports, validation summary reports, and final deliverable packages in a format that meets regulatory expectations.

Risk-Based Validation (GAMP 5)

Using GAMP 5 methodology, we classify systems based on risk, complexity, and impact. This lets us scale validation effort appropriately so that your resources are focused where they matter most.

Data Integrity Assessment

We conduct assessments against ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus additional controls). We review audit trails, user permissions, versioning, and access controls to identify data integrity vulnerabilities.

Periodic Review & Change Control

Systems do not remain static. Through periodic reviews, revalidation activities, and change control processes, we ensure your validated state is maintained even when software updates or business process changes occur.

Retirement & Data Migration Validation

When systems are retired or replaced, we ensure safe, controlled decommissioning. Our data migration validation ensures historical data is preserved, integrity is maintained, and compliance with record retention policies is upheld.

Why Choose Inglasia for Your CSV Needs

Your validation project deserves more than a check-box consultancy. Here is what sets us apart:

Established Expertise: Operating in London, our team has supported global pharma and biotech companies since 2011.
Regulatory Alignment: We understand MHRA, EMA, FDA, and other regulator expectations and develop validation packages accordingly.
Risk-Informed Approach: Using GAMP 5 as a foundation, we scale our activities to focus on high-risk systems.
Sustainable Validation: Our support does not end at delivery, we help you maintain validated status year after year.
Transparent Communication: We work closely with IT, QA, and system owners, bridging gaps and aligning teams through our “Seven Pillars of Quality.”
Local Presence: Based in London, we can provide onsite support or remote consulting depending on your project needs.

Industry Context: Why CSV Has Never Been More Important

Regulators have placed increasing emphasis on data integrity and computerised systems. According to CSV-specialist resources, more audit findings originate from incomplete documentation, weak change control, and missing traceability.

GAMP 5 remains the benchmark for risk-based validation. Organisations applying its lifecycle model can manage validation in a structured, efficient way.

In the UK, GxP guidance such as MHRA’s expectations and the UKCRF Network’s advisory notes confirm that CSV is not optional, it is a core component of quality systems.

Frequently Asked Questions

Q: How often should systems be revalidated or reviewed?
A: We recommend a risk-based recurring cycle. For many systems, that means a full review every 1–3 years or sooner if significant changes are introduced. Revalidation ensures your system remains compliant, especially after updates or configuration changes.

Q: Can cloud-based or SaaS platforms used in pharma be validated?
A: Yes. Cloud and SaaS systems are subject to the same GxP, ALCOA+, and risk-based validation as on-premise systems. While vendors may provide validation documentation, you remain responsible for confirming the system works in your specific configuration and use case.

Q: Do we need vendor documentation during our validation?
A: Vendor documentation (such as design specs or test reports) is useful, but it is not enough by itself. We validate the system in the context of your intended use, ensuring that your configuration complies with regulatory and business needs.

Q: What do inspectors look for in audit trails and electronic records?
A: Inspectors will scrutinise audit trails for completeness, sequence, timestamp accuracy, and access control. They want to confirm that every critical action is recorded, traceable, and justified. This is a core element of data integrity.

Q: What are common mistakes companies make in CSV?
A: Some frequent errors include:

Relying solely on vendor validation without independent testing
Poor or missing traceability between requirements and tests
Not performing revalidation after significant changes
Inadequate user training on validated processes

Q: How do we handle data migration when retiring a system?
A: We create validation protocols for data migration, ensuring legacy data is transferred, verified, and stored securely with full integrity. We also address retention policies and regulatory record-keeping.

Q: What documentation will be delivered at the end of the validation project?
A: You will receive a full validation package: master plan, protocols (IQ/OQ/PQ), test scripts and results, traceability matrices, risk assessment reports, validation summary, and final report, all ready for regulator review.

Q: Can you train our staff on maintaining validated systems?
A: Yes. We provide hands-on training to your quality, IT, and system-owner teams so they understand how to maintain validated state, manage change control, and execute periodic reviews.

Final Call to Action

If inspection readiness, data integrity, and regulatory compliance matter to your business, then investing in Computer System Validation Services is not just prudent, it is essential.
Inglasia brings over a decade of GxP validation experience, deep regulatory insight, and a tailored, risk-based approach that protects both your operations and reputation.

Book a call with our London-based team today. Let us help you assess your systems, define your validation path, and maintain compliance for the long term.