In the modern life sciences and regulated industries, computerised systems are the backbone of R&D, manufacturing, clinical trials, quality assurance, and pharmacovigilance. At Tech Qualitas, we help organisations achieve and maintain compliance by offering end-to-end Computer System Validation (CSV) services that are audit-ready, risk-based, and aligned with global regulatory standards.
With over 40 years of combined expertise, we have successfully supported numerous clients in validating critical systems — ensuring data integrity, patient safety, and product quality throughout the system life cycle.
Unvalidated systems can jeopardise:
Compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, ISO 13485
Regulatory inspection outcomes
Data traceability and security
Business continuity and operational quality
Computer System Validation ensures:
Your systems function as intended
Risks are identified and mitigated
Documentation is compliant and audit-ready
Lifecycle control and change management are maintained
We deliver a full spectrum of CSV services tailored to system complexity and risk, including:
CSV risk assessment and planning
21 CFR Part 11 and Annex 11 GAP analysis
GxP applicability assessments
Our scalable and proven CSV methodology follows a process-oriented and risk-based approach. Inspired by GAMP 5 and international regulatory standards, our validation framework includes:
Lack of a structured plan
Poor documentation and traceability
Inadequate testing and coverage
Weak risk management processes
Tech Qualitas partners with clients to build comprehensive validation plans, ensure documentation excellence, execute robust testing, and apply industry-standard risk controls to keep your systems validated and compliant.
ERP, QMS, LIMS, DMS, LMS
Clinical Trial and PV Systems
Custom-built applications and SaaS solutions
Cloud-hosted platforms and spreadsheets
Expertise You Can Trust
Decades of hands-on experience with validated systems across multiple regulated industries.
Inspection-Ready Documentation
Our deliverables meet the highest standards and are designed to withstand the scrutiny of regulatory inspections.
Tailored Solutions
From full-service validation to modular consulting packages, our approach adapts to your needs.
Risk-Based, Cost-Effective Execution
Focused on quality and compliance without excessive cost or time burden.
Training & Knowledge Transfer
We empower your team through dedicated training, ensuring sustainability of compliance practices.
Founder
