Documentation Package

Pre-defined templates and process models for all validation steps.

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Digital Transformation in computerized system validation

DHC VISION is well prepared for use in highly regulated industries (e.g. GxP/FDA regulations). A large collection of field-tested document templates is available for accelerated system validation. Using such templates safes considerable time; there is no need to design and develop comprehensive validation documentation and SOPs from scratch. Our customers enjoy the full benefit of efficiency gains in software validation.

DHC VISION “Validation Accelerators” are templates and process models for all relevant validation steps. Accelerators are available for: Validation plan, part 11 analysis, user requirement specification (URS) and test case definition, final validation report. Only marginal adaptations are needed to document and reflect the specific corporate context in which DHC VISION is used. Validation Accelerators, thus, speed up the validated implementation of DHC VISION; they reduce validation efforts significantly; and, finally, they foster reliability with regard to IT compliance.

DHC supports system implementation as well as prospective system validation with their proven validation methodology. More than 20 years of experience with several thousand projects implemented for over 200 customers worldwide stand for reliable service delivery and excellence in Computer System Validation.

„Validation Accelerators“ stand for the consistent further development of DHC’s template-based and process-oriented approach to Computer System Validation (CSV) and for its application to DHC software products. They are aligned to the V-model according to GAMP®5, ISO norms or other pertinent legal requirements, e.g. 21 CFR Part 11, Annex 11 of EU GMP guidelines and the ISO 13485 requirements for medical devices.

For a complete list of our validation expertise and services, please click here.

Whitepapers are available on DHC VISION’s “21 CFR Part 11 Conformity”, “DHC VISION Validation Accelerators”, and the “Validated Implementation of DHC VISION”. Please order your complimentary copy here.