PROCESS AND PRODUCT VALIDATIONS

Validation program
Validations are the final steps of your product and process development before ramping up manufacturing and scaling up operations. Successful validations don’t happen because of luck but as a result of a well design and integrated validation program. We will help you think ahead so that the validations become a confirmation of anticipated results.

We will develop a user friendly and comprehensive validation program including:

  • Design of experiments
  • Computer validation (part 11 compliant)
  • Equipment IOQ
  • Test method validation
  • Process validation
  • Product validation
  • Validation Master Plan

A customized turnkey validation will facilitate the transition of new product design into production.

Validations
Validation protocols and reports are often part of regulatory submissions. The quality of these documents will reflect on your organization. Incomplete, or unclear protocols may lead to a lengthen review process by raising questions from the agency. A thorough, well structured validation protocol or report will ease the reviewing process.

In addition to a comprehensive validation program, Gloster Biomedical International can develop specific protocols and reports for your unique project. While working closely with your team, we will prepare and execute successful and compliant validations.

You may also consider asking us to develop validation templates that can be used over and over, hence shortening the validation effort of future projects.

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Gloster Biomedical International • 577 N. Hope Ave, Suite 101 • Santa Barbara, CA 93110 • USA • Tel: +1-805-679-1258
www.GlosterBiomedical.com

Copyright © 2008-2009 Catherine Gloster - Gloster Biomedical International - All rights reserved.