Ensuring Compliance, Quality, and Patient Safety Across the Entire Product Lifecycle
In the highly regulated life sciences sector, validation is essential to guarantee that systems, processes, and equipment perform consistently, accurately, and in full compliance with global regulatory standards. Our Validation Services practice supports pharmaceutical, biotechnology, medical device, and clinical research organizations in meeting stringent requirements while accelerating product development and maintaining operational excellence.
We deliver end-to-end validation solutions designed to ensure data integrity, reduce compliance risks, and streamline regulatory readiness—empowering organizations to focus on science, innovation, and patient outcomes.
Our Validation Capabilities
Computer System Validation (CSV)
We provide comprehensive CSV services aligned with GxP, FDA 21 CFR Part 11, EU Annex 11, and industry best practices.
Our services include:
- Validation planning and risk assessments
- Requirements definition and traceability
- IQ/OQ/PQ protocols and execution
- Electronic systems and laboratory system validation (LIMS, ELN, CDS, MES)
- Data integrity assessments and remediation
- Periodic reviews and system revalidation
Equipment & Instrument Validation
Ensure that laboratory and manufacturing equipment operate reliably and consistently.
We deliver:
- Equipment qualification (DQ, IQ, OQ, PQ)
- Calibration and maintenance compliance
- Utility system validation (HVAC, water systems, compressed air)
- Qualification of analytical instruments
- Validation documentation aligned with GMP/GLP guidelines
Process Validation
Support robust process design, performance qualification, and continued verification.
Our expertise includes:
- Stage 1: Process Design
- Stage 2: Process Qualification
- Stage 3: Continued Process Verification (CPV)
- Technology transfer and scale-up validation
- Cleaning validation and cross-contamination control
- Validation of biologics and small molecule processes
Software Validation for Medical Devices
Ensure regulatory compliance for device software under FDA, ISO 13485, and IEC 62304 standards.
We provide:
- SDLC documentation and verification
- Software risk management per ISO 14971
- Embedded system validation
- Usability/human factors validation
- Post-market surveillance validation support
Facility & Utility Validation
Guarantee controlled environments that support manufacturing and quality operations.
Our offerings include:
- HVAC, cleanroom, and controlled environment qualification
- Water for injection (WFI) and purified water systems validation
- Environmental monitoring programs
- Sterilization and decontamination system validation
- Facility commissioning and qualification
Validation Documentation & Audit Support
Strengthen compliance and support seamless regulatory inspections.
We deliver:
- SOP development and lifecycle management
- Validation Master Plans (VMP)
- GAP assessments and audit readiness programs
- Mock audits and regulatory inspection support
- CAPA development and remediation plans