IT Infrastructure & Compliance

Validated Systems. Zero Audit Risk.

In a regulated environment, your IT systems are not just operational tools — they are subjects of regulatory scrutiny. A single data integrity finding or unvalidated system can halt production, delay a submission, or trigger a Warning Letter. Clarus Research delivers GAMP 5-aligned computer system validation, robust 21 CFR Part 11 and Annex 11 compliance programmes, and cloud infrastructure built specifically for GxP workloads.

We work with the systems that matter most in pharma and biotech — LIMS, MES, DMS, QMS, CTMS, EDC platforms, and clinical data repositories — ensuring they are validated, compliant, and audit-ready.

Our Services

Our IT Services

Computer System Validation (CSV) & Computer Software Assurance (CSA)

GAMP 5 and FDA CSA guidance-aligned validation programmes for Category 3–5 software
User Requirements Specification (URS), risk assessment, and Functional Design Specification (FDS)
IQ / OQ / PQ protocol authoring, execution support, and formal report generation
Periodic review programmes and revalidation management
Validation Master Plan (VMP) — site-level strategy covering scope, roles, and lifecycle standards

21 CFR Part 11 & Annex 11 Compliance

System-level compliance gap assessments with risk-ranked findings
Electronic records and electronic signature (ERES) control reviews
Audit trail configuration, review SOPs, and operational procedures
Prioritised remediation roadmaps referenced to FDA predicate rules and EMA Annex 11

Managed IT Support for Regulated Environments

GxP Cloud Infrastructure

Validated cloud deployments on AWS GovCloud, Microsoft Azure, and Google Cloud Platform
Infrastructure qualification (IQ) for GxP-critical cloud environments
Data residency planning, backup validation, and disaster recovery (DR) for regulated workloads
Managed security and access control architecture aligned with 21 CFR Part 11

Data Integrity Programmes

ALCOA+ gap assessments across chromatography data systems (CDS), LIMS, and MES platforms
Audit trail integrity reviews and access control analysis
End-to-end remediation programmes — from root cause identification through regulatory health authority response
Data governance frameworks and data lifecycle management procedures

Talk to Our Experts

Not Sure Where to Start?

Whether you have a specific project in mind or know there are data or compliance gaps you need to address, our team can help you identify the right priorities. Schedule a free 30-minute discovery call and leave with a clearer picture of your next steps.

Book a Free Discovery Call