Computer System Validation (CSV) Services

Validate your computer systems faster than you can say UAT

Smart, scalable CSV solutions for Regulated Businesses

A strong validation framework is essential for compliance and operational efficiency. We design, implement, and manage Computer System Validation (CSV) programs to ensure your validation activities align with regulatory expectations and best practices.

Your software providers impact your compliance. We conduct vendor audits and risk assessments to evaluate third-party systems, ensuring they meet regulatory requirements and minimize compliance risks for your business.

Regulatory compliance starts with robust documentation. We prepare all required validation documents—Validation Plans, User Requirements, Functional Specs, and Test Protocols—ensuring your system is fully documented and audit-ready.

Validation isn’t just about paperwork—it must be tested. We conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to verify system performance, ensuring compliance and reliability.

Standardized procedures are critical to maintaining a validated system. We develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) tailored to your operations, ensuring compliance and consistency in system use.

Regulations evolve, and so should your validation strategy. We provide ongoing compliance support, ensuring your validated systems remain compliant, efficient, and ready for audits at all times.

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When should you call us?

Validation and data integrity don’t just protect your systems—they protect your business. If you’re facing any of these situations, Patero is here to help.

Whether it’s an eQMS, ERP, or lab system, we’ll help ensure validation and data integrity are built in from the start—not left as an afterthought.

Legacy system? Cloud-based platform? We evaluate your setup and define a right-sized, risk-based validation approach aligned with GAMP 5 and regulatory expectations.

From missing audit trails to weak access controls, we identify and close the gaps before they become regulatory findings.

Already have a CSV or DI plan? We step in to help execute—writing protocols, running tests, documenting evidence, and supporting project delivery.

We perform retrospective validation and build remediation plans that align with current guidance—so you’re inspection-ready and protected moving forward.

We assess your current state, prioritize gaps, and help you get everything in place—from updated documentation to governance programs—before auditors arrive.

Our validation bread and butter

Regulated industries require strict compliance with Health Canada, FDA, and GMP regulations, but without proper system validation, businesses risk audit failures, data integrity issues, and operational inefficiencies. At Patero, we provide comprehensive Computer System Validation (CSV) services to ensure your critical systems are compliant, secure, and optimized for performance.

The Patero Validation Framework

We kick things off by developing a clear validation plan that outlines what’s being validated, why, and who’s responsible for what. At the same time, we help document your user requirements so there’s alignment between how the system needs to work, what the business expects, and what regulators will be looking for.

Once the requirements are nailed down, we help manage the RFP process and support you in evaluating potential vendors. We also carry out vendor assessments to make sure the software and its suppliers meet both your operational needs and the right regulatory standards.

Using GAMP 5 principles, we assess the system’s risk and impact so we can right-size the validation effort. That means identifying what’s critical, classifying the system appropriately, and designing a validation approach that’s proportionate to its role in your operations and the level of regulatory oversight it needs.

We translate your requirements into functional and design specifications—laying out how the system will work, how it meets business needs, and how it stays compliant. These documents create traceability through the entire validation process.

We prepare all the validation protocols and deliverables you need, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and a full traceability matrix. Everything is structured to meet global regulatory expectations—whether it’s 21 CFR Part 11, Annex 11, or GAMP 5.

We manage or execute testing activities, verifying that everything is installed, configured, and working as intended. Test results are fully documented, and any deviations are tracked and handled in line with cGMP expectations.

We close out the project with a final validation report that ties everything together—test results, justifications, conclusions, and traceability. And if you need ongoing support, we help you build a sustainable data integrity program that keeps your validated systems compliant long after go-live.

Frequently asked questions

Client Experience

Director of Quality Assurance

Large Multinational Pharmaceutical Organization

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