Independent Validation Consultancy
We verify what others build. FDA, EMA, and ICH compliance — certified by an independent third party.
Request AssessmentWhat We Do
End-to-end pharmaceutical validation from independent specialists. Every engagement is scoped, executed, and reported by qualified professionals with no vendor affiliations.
Installation, Operational, and Performance qualification protocols for computerized systems. Full evidence packages with traceability matrices.
Learn more →ALCOA+ compliance assessment, gap analysis, and remediation planning. Systematic review of electronic records and audit trail integrity.
Learn more →Electronic records and signatures compliance assessment for FDA-regulated systems. Detailed findings with prioritized remediation roadmap.
Learn more →Computerized system validation for EMA compliance. Risk-based approach covering system lifecycle, data management, and operational controls.
Learn more →Risk-based validation lifecycle per ISPE guidelines. Software categorization, functional risk assessment, and validation strategy definition.
Learn more →Full CSV lifecycle: user requirements, functional specifications, design specs, test protocols, execution, and traceability documentation.
Learn more →Mock inspections, documentation review, and audit trail verification. Identify and close gaps before the regulator arrives.
Learn more →Complete IQ/OQ/PQ documentation packages with test cases, expected results, acceptance criteria, and execution-ready protocols.
Learn more →About Veridatum
Veridatum was founded by validation specialists with 15+ years of experience in pharmaceutical quality systems. We operate independently from software vendors, platform providers, and system integrators.
That independence is not incidental — it is foundational. When we certify a system, our only interest is accuracy. We do not sell software. We do not take referral fees. We have no financial relationship with the systems we validate.
Our assessors have executed qualification protocols across LIMS, ERP, QMS, ELN, and custom data platforms for organisations ranging from early-stage biotechs to multinational pharmaceutical manufacturers.
Our Process
We learn about your systems, regulatory context, and timeline. No sales pitch — just a technical conversation to determine scope and feasibility.
Systematic review of your current validation posture. We identify gaps against FDA, EMA, and ICH requirements and deliver a prioritized findings report.
We author qualification protocols tailored to your systems — IQ, OQ, PQ test cases with acceptance criteria, traceability matrices, and risk assessments.
Protocols executed against your live environment. Evidence collected, deviations documented, results analysed. Every step timestamped and attributable.
Comprehensive validation report with executive summary, detailed findings, evidence appendices, and formal certification. Inspection-ready from day one.
Industries We Serve
Pharmaceutical Manufacturing
Biotech R&D
Clinical Research Organizations
Medical Device Companies
Contract Manufacturing (CDMOs)
Trusted by quality teams at Series A biotechs, global pharmaceutical manufacturers, and FDA-regulated contract research organisations across North America, Europe, and Asia-Pacific.
Get Started
Tell us about your system and regulatory requirements. We will respond within one business day with a scoping proposal.