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As documented evidence that computer-supported systems were correctly specified under consideration of the regulatory requirements, were correctly implemented and installed according to their specification and fulfil all requirements for their productive operation.
Our offer
Consultation and personnel support in the validation of computer-supported systems in accordance with the applicable guidelines and recommendations (e.g. Annex 11, 21 CFR Part 11, PIC/s PI-011, GAMP 4, etc.)
Our Services
Competent and experienced IT validation experts guide you through the projects for prospective and retrospective validation of computer-supported systems (e.g. PLS, LIMS, ERP systems) from planning to reporting. On the basis of an established life cycle-based procedure our specialists draft together with you a system and project-specific validation approach and support you in the implementation. The level of support ranges from consultation to creation of documents and sole responsibility for implementation of inspections. A set of approved document templates guarantees an up-to-date, consistent documentation of the validation process, which conforms to official requirements.
Beyond production of valid status, we also advise and support you with regard to maintenance of valid status, e.g. in planning and implementing a change control process.
Your Result
Validated IT systems with all associated documents, such as validation plans, risk analyses, test specifications / protocols, reports and SOPs
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Consulting
