Applitech Infotech provides full-service Validation and GMP Compliance consulting for pharmaceutical, biotech, medical device, and medical diagnostic industries. The practice specializes in preparation and execution of validation and compliance documents for equipment, utilities, processes, laboratory instruments, and computerized systems, along with program management for large engineering, construction, and validation projects.
Overview
Applitech's philosophy is that a true life-cycle approach is necessary to implement and validate projects in full compliance with cGMP regulations. Success depends on integrating function, structure, and test considerations across diverse groups. Applitech can bring the entire team together and manage the activities to ensure timely validation at reasonable cost.
Who we serve
Applitech is staffed with professionals of considerable experience and diverse educational disciplines, so the firm offers a broad portfolio of validation and compliance services. Clients range from the largest multi-national corporations to small biotechnology start-ups, and the team has performed successful projects throughout the USA and abroad. Services are not limited to new projects, the same experience applies to continuing operations.
Consulting services include
- 01Validation program development
- 02Validation master planning
- 03Computer system validation planning
- 04cGMP operational audits
- 05cGMP design audits
- 06Pharmaceutical technology and equipment
- 07cGMP recovery plans
- 08Process and facility troubleshooting
Program management services include
- 01Estimating
- 02Scheduling and tracking
- 03Resource management including procurement and sub-contract management
- 04Turnover, commissioning, and start-up
- 05Consent decree management
Why Applitech for validation
Validation lives or dies on documentation and discipline. Our consultants are geared not just toward uncovering problems but toward providing solutions, with the documentation rigor required by FDA, EMA, and other regulators across the world.