Applitech's validation approach is built around quality assurance, hands-on project management, diverse-team staffing, and equipment readiness. The combination delivers work that complies with the GMPs, controls scope and cost, and brings the right specialists to bear on each phase of execution.
Quality assurance
Applitech follows a proven approach to validation and compliance that delivers work guaranteed to comply with the GMPs. Group activities are governed by an extensive set of internal Standard Operating Procedures (SOPs) that are regularly revised as regulation and best practice evolve.
Project management
Effective on-site project management controls the scope and project cost, ensures reliable delivery of services, allows for innovation, and reduces the client's overall exposure to risk. Engagements are managed against transparent milestones with clearly defined deliverables.
Diverse team approach
Projects are staffed with consultants drawn from chemistry, pharmacy, microbiology, engineering, metrology, and IT. This breadth is critical: validation rarely sits inside a single discipline, and the team has to be able to read process, equipment, and software in equal measure.
Latest equipment
Applitech maintains an inventory of the validation testing equipment typically required for field execution, so consultants arrive with the calibrated instruments needed to perform tests on day one rather than wait for procurement cycles.
Methodology fit
- 01GAMP 5 risk-based approach to computer system validation
- 02V-model alignment of specifications, design, and testing
- 03IQ, OQ, and PQ execution with traceability throughout
- 0421 CFR Part 11 and EU Annex 11 alignment for electronic records
- 05Periodic revalidation cadence tied to change control