Computer System Validation (CSV) Services
In the pharmaceutical and biotech industries, every system used to manage production, quality, or distribution must be validated to meet GMP and GDP standards. Failure to comply can disrupt operations, trigger regulatory actions, and compromise patient safety.
Inglasia Pharma Solutions provides senior CSV services to ensure your electronic systems, software, and cloud platforms are compliant, reliable, and inspection-ready.
Since 2011, we’ve helped global manufacturers, biotech innovators, and distributors maintain validated systems, protect data integrity, and operate with confidence in highly regulated environments.
Request a Free ConsultationWhy Computer System Validation Matters in Pharma and Biotech?
Pharmaceutical systems accomplish more than holding information. They track every step of a product, monitor quality control checks, control supply chains, and get medications to patients in a safe manner. If not validated, these systems are liabilities rather than assets.
Why businesses look for CSV assistance:
- Regulatory Compliance: FDA, EMA, MHRA, and similar regulators insist on hard compliance with validation procedures.
- Data Integrity: All data, ranging from test results to shipment records, should be accurate, secure, and traceable.
- Operational Continuity: Failed audits or unvalidated systems can stall production and cause delays that cost millions.
- Patient Safety: In its essence, validation guarantees that the patient gets safe and effective medication, unencumbered by unnecessary risks.
Inglasia addresses all these aspects by delivering on-site validation services, remote consulting, and end-to-end CSV support tailored to the stage of your operations.
Our Approach to Computer System Validation Services
We don’t believe in one-size-fits-all validation. Each system, each process, and each client demands an individualized, risk-informed approach. Our Seven Pillars of Quality: Question, Understand, Accept, Liaise, Inform, Trust, You guide the way we work as an extension of your team.
Lifecycle View
From planning through testing, reporting, and maintenance throughout the complete system lifecycle.
Risk Assessment Before All Else
First identifying the key processes that affect product quality and patient safety.
Documentation Accuracy
Validation templates, protocols, and reports that meet regulatory examination.
End-to-End Support
From initial implementation to long-term monitoring and revalidation.
💡 Global Reputation: This alignment of extensive regulatory knowledge and agile, quality-focused delivery has established Inglasia as a reliable partner for pharma businesses worldwide.
Industries and Systems We Validate
Our computer system validation services extend across the full pharma and biotech spectrum, covering:
Laboratory Systems
LIMS, ELN, chromatography systems
Manufacturing Equipment
MES, ERP-integrated systems
Distribution & Logistics
Warehouse management, freight monitoring
Quality Systems
Document management, CAPA systems
Clinical Data Systems
EDC platforms, trial management software
Each of these systems requires tailored validation protocols to ensure regulatory compliance and operational integrity.
What Our Computer System Validation Services Include
Our services cover every aspect of system validation, helping your business stay inspection-ready and fully compliant.
Validation Planning & Strategy
We define validation needs, create master plans, perform risk assessments, and establish system specifications.
Protocol Development & Execution
From IQ, OQ to PQ, we design and execute protocols aligned with GMP/GDP standards.
Documentation & Templates
We deliver regulatory-grade templates ensuring consistency, accuracy, and audit-readiness.
Validation Consulting & Gap Analysis
We analyze weaknesses and offer tailored solutions, from one-off reviews to ongoing consulting.
Training & Knowledge Transfer
Our training equips your staff with practical skills to maintain validated systems confidently.
Revalidation & Ongoing Support
We manage revalidation, updates, and monitoring as systems evolve to keep compliance intact.
Why Choose Inglasia for CSV?
Since 2011, Inglasia has built a reputation for delivering quality without compromise. Our USP lies in our adaptability — we scale services up or down, acting as your full Quality Department or stepping in for a targeted CSV project.
What sets us apart:
- Flexibility: On-demand support, from one-off validation projects to long-term partnerships.
- Principle-Driven Philosophy: Our Seven Pillars of Quality keep patients at the heart of every decision.
- Experienced Specialists: Every consultant brings hands-on experience with pharma regulatory audits worldwide.
- Transparency and Trust: Clear documentation and open communication throughout the project.
In an industry where compliance failures can cost millions, our computer system validation services offer more than compliance — they deliver peace of mind.
Unique Insights: What Most Don’t Tell You About CSV
Many service providers treat CSV as a box-ticking exercise. At Inglasia, we go deeper. Here are some under-discussed truths:
- Revalidation is often neglected: Systems evolve constantly. Ignoring revalidation is one of the top reasons for audit findings.
- User training is as important as system testing: The best validation fails if users don’t follow procedures.
- Risk-based validation saves resources: Not every component carries equal risk, understanding critical points avoids wasted time and cost.
- Data migration is high risk: Moving legacy data into validated systems must be handled with precision to avoid compliance gaps.
These insights guide our approach, ensuring validation is not just compliant, but sustainable.
Our Process: Step-by-Step Computer System Validation
When you partner with Inglasia, you can expect a clear, structured process:
Initial Assessment
Review systems, risks, and regulatory requirements.
Validation Planning
Develop master plan, responsibilities, and timelines.
Protocol Development
Draft IQ, OQ, PQ documents.
Execution & Testing
Perform testing, record results, and address deviations.
Documentation & Reporting
Compile audit-ready reports for regulators and stakeholders.
Handover & Training
Equip your team with knowledge for ongoing compliance.
Continuous Support
Provide revalidation, monitoring, and updates as systems evolve.
The Cost of Non-Compliance
The financial and reputational risks of ignoring system validation are significant:
- Regulatory Penalties: FDA warning letters, EMA non-compliance reports
- Operational Delays: Halted production or shipment recalls
- Lost Revenue: Missed market launches or suspended licenses
- Reputation Damage: Loss of trust among regulators, partners, and patients
By investing in computer system validation services, organizations avoid these costly pitfalls and safeguard long-term success.
Ready for Inspection Confidence?
Validation is not just a requirement, it’s a commitment to patient safety and product integrity. At Inglasia, we bring over a decade of expertise, a principled approach, and a track record of successful inspections worldwide.
Whether you’re preparing for your first regulatory submission or maintaining global commercial operations, our computer system validation services give you the confidence that your systems will withstand scrutiny.
Your systems. Your patients. Your reputation. Validated. Book a call now.
Frequently asked questions
Validated systems must be reviewed on a risk-based cycle, usually every 1–3 years, or more often if there is substantial change like upgrades of software, introduction of new functionalities, or process changes. Regulators look for assurance to be ongoing rather than a one-off exercise.
Yes. Cloud and SaaS systems must also meet GMP and GDP requirements. While vendors provide some validation evidence, the regulated company remains responsible for ensuring the system is fit for intended use and fully documented.
Vendor-provided documentation, including design specs or test reports, can aid in validation but is not adequate alone. Businesses have to independently confirm system performance in their intended application and regulatory environment.
Auditors review audit trails for completeness, integrity, and indications of tamper resistance. Inspectors usually check for user access controls, time-stamped activity logs, and whether or not the changes are well-recorded and justified.
Typical errors involve insufficient documentation, inadequate training of users, inattention to revalidation following change, and dependence on vendor validation packages without carrying out internal verification.