Validation expertise
Each discipline has a dedicated technical page: what it covers, how it is executed, and where programs most often go wrong.
Engineering & process
Qualification and validation engineering
CQV & CommissioningRisk-based commissioning and qualification for regulated facilities: integrated C&Q strategy, FAT/SAT, turnover packages, facility startup and brownfield expansion.Equipment QualificationQualification of manufacturing, laboratory, packaging, sterilization and bioprocess equipment — from design qualification through performance qualification and periodic review.Process ValidationProcess validation across the lifecycle: process design, process performance qualification and continued process verification, supported by sound statistics and risk management.Cleaning ValidationCleaning validation strategy: health-based limits, worst-case product grouping, sampling and recovery studies, analytical methods, CIP qualification and lifecycle monitoring.Computerized SystemsRisk-based assurance for GxP computerized systems: CSV, Computer Software Assurance, 21 CFR Part 11, data integrity, supplier assessment, testing and periodic review.Laboratory ValidationLaboratory validation across instruments, equipment and informatics: analytical instrument qualification, LIMS, ELN, CDS, method validation, calibration and data integrity.Medical Device & IVDValidation for medical device manufacturers: production equipment and process validation, automated manufacturing, test equipment, and quality system software assurance.AI ValidationA practical framework for assuring AI and machine learning applications used in GxP and quality environments: intended use, risk, controls, human oversight and monitoring.
Computerized systems
Software assurance, records and data integrity
Computer System Validation (CSV)Computer system validation across the lifecycle: requirements, risk assessment, configuration, testing, traceability, release and periodic review for GxP systems.Computer Software Assurance (CSA)What Computer Software Assurance means in practice: intended use, risk-based assurance activities, unscripted testing, and how CSA relates to traditional CSV.21 CFR Part 11Practical 21 CFR Part 11 assessment: applicability determination, technical and procedural controls, audit trails, electronic signatures, open and closed systems.Data IntegrityData integrity in regulated operations: ALCOA+ principles, data lifecycle mapping, system-level controls, audit trail review and remediation programs.Electronic Records & SignaturesDesigning and assessing electronic record and electronic signature controls: official record determination, signature manifestations, linking, and hybrid workflows.Audit TrailsAudit trail design, configuration verification and risk-based audit trail review procedures for GxP computerized systems and laboratory instruments.SaaS / Cloud ValidationValidating cloud and SaaS systems in regulated environments: supplier assessment, shared responsibility, continuous release, qualification of infrastructure and data location.LIMS ValidationLIMS validation for regulated laboratories: requirements, configuration, specification and sample workflows, instrument interfaces, calculations, migration and Part 11 controls.