From validation strategy to testing, documentation, and ongoing compliance, Patero provides hands-on computer system validation services for pharmaceutical and biotechnology organizations.
Our P.Eng.-led team brings 25 years of validation experience to help you implement and maintain GxP computerized systems with confidence.
Whether you need a complete validation program or specialized support for a specific project, our team works alongside yours to deliver reliable, compliant systems. From initial assessments to ongoing compliance, our services are tailored to your systems, operational needs, and regulatory requirements.
We help organizations validate the technologies that support product quality, manufacturing, laboratory operations, and regulatory compliance.
Electronic quality workflows and regulated records.
Manufacturing, supply chain, and inventory processes.
Document control and regulatory submission platforms.
Laboratory information and chromatography data systems.
Product identification and traceability systems.
HVAC and GxP-relevant environmental systems.
Maintenance and equipment management systems.
Risk-based validation of regulated spreadsheets.
Don’t see your system listed? We validate a wide range of computerized systems tailored to your operational and regulatory needs.
Validation and data integrity don't just protect your systems—they protect your business.
Discuss your project↗ You're rolling out a new GxP or SaaS system
Build validation and data integrity into your implementation from day one.
◇ You're unsure what validation is needed
Define a right-sized approach based on intended use and risk.
◈ You need to address data integrity gaps
Identify and remediate audit trail, access, and documentation weaknesses.
＋ You've got the strategy but need extra hands
We support protocols, testing, evidence, and project delivery.
▤ You're working with legacy systems
Assess existing records and develop remediation plans.
◎ You're preparing for an inspection
Prioritize gaps and prepare defensible validation evidence.
Our framework focuses effort where it matters most while maintaining the documentation and traceability required for regulated operations.
Establish the strategy, responsibilities, and user requirements.
Support software selection and evaluate supplier evidence.
Assess critical functions and scope validation based on risk.
Translate requirements into traceable specifications.
Develop appropriate IQ/OQ/PQ protocols, SOPs, and work instructions.
Execute testing, document evidence, and investigate deviations.
Consolidate evidence and support lifecycle controls.
Computer system validation (CSV) is the documented process of demonstrating that a computerized system consistently performs as intended and is suitable for its regulated use.
For systems used in regulated pharmaceutical and biotechnology activities, applicable laws and regulations can require documented validation. The scope depends on the system’s intended use and its impact on product quality, patient safety, and data integrity.
Validation does not end at go-live. Systems must remain in a validated state throughout their lifecycle through appropriate change control, periodic reviews, testing, and documentation as they evolve.
Traditional CSV
Requirements, specifications, qualification, testing, and traceability.
Computer Software Assurance (CSA)
Risk-based assurance focusing effort on critical functions and intended use.
Validation 4.0
Lifecycle thinking for modern, connected, and cloud-based technologies.
AI governance in regulated environments
Documentation, registration, risk assessment, and governance of AI-enabled systems.
Practical answers to common questions about regulated systems and validation.
Implementing a new GxP system or addressing data integrity gaps? Tell us about your project.
