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Solutions > Validation Compliance

Applitech Infotech provides full service Validation and GMP Compliance consulting services for pharmaceutical, biotech, medical device, and medical diagnostic industries. Applitech specializes in the preparation and execution of validation and compliance documents for equipment, utilities, processes, laboratory instruments, and computerized systems.  We also offer program management for large-scale engineering, construction and validation projects.

Applitech’s philosophy holds that a true “life-cycle” approach is necessary to implement and validate projects in full compliance with CGMP regulations. The successful project involves the integration of function, structure and test considerations and requires the efforts of diverse groups. Applitech can bring the entire team together and will manage their activities to ensure a project validated in a timely manner and for a reasonable cost. Applitech is staffed with professionals of considerable experience and diverse educational disciplines. Consequently we offer a broad portfolio of validation and compliance services. Applitech's clients have ranged from the largest multi-national corporations to small biotechnology startups. The team has performed successful projects throughout the USA and abroad.

Services are not limited to new projects. We can apply our experience to continuing operations, as well. In all cases, or consultants are geared not merely toward uncovering problems, but toward providing solutions.

  • Validation program development
  • Validation master planning
  • Computer system validation planning
  • CGMP operational audits
  • CGMP design audits
  • Pharmaceutical technology and equipment
  • CGMP recovery plans
  • Process and facility troubleshooting
  • Estimating
  • Scheduling/Tracking
  • Resource management, including procurement and management of sub-contracts
  • Turnover, commissioning and start-up
  • Consent decree management