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(Re-)validation and support during audit preparation

Project duration: 1 month

Brief description

Consulting and support provided to a pharmaceutical laboratory for validation and documentation of its computer, measuring and laboratory systems at GxP standard, as well as preparation and reworking of an external audit. A gap analysis is also performed in cooperation with project and quality management, this is used as the basis for creating and implementing audit preparation and validation planning.

Supplement

At the start of the project, the audit-relevant processes, systems for automated data processing, and work instructions (SOPs) and associated documentation are reviewed and checked. The focus is on the established and documented processes and systems, as well as the existing IQ, OQ and PQ validation protocols. Changes, deviations or gaps such as insufficient documentation (e.g. VBA code); non-validated systems or components; deviations from standard and base technologies (e.g. non-compatible audit trails); insufficient monitoring of changes and configuration management; insufficient user rights (authentication and authorization) and information security (confidentiality, availability and integrity); missing training documentation or lack of training, as well as inadequate security guidelines are documented, evaluated, transferred to the regulated change management process, implemented and revalidated, if necessary.

Subject description

Various different sub-steps are required to demonstrate that systems and processes work as expected and forecast: The systems are identified based on a computerized system inventory and GAMP5 software categories (infrastructure-specific, non-configured, configured, individual). Activity controlling is performed via a steering committee as well as regular reports. Risk evaluation is performed at three levels: Low – Minimum interference with work processes; Medium – Danger to property, finances or legal regulations; High – Danger for patients or users. Different test strategies are used for validation, depending on the risk and category. The defined deficiencies or errors are documented, removed, or measures are taken to alleviate them. The systems are transferred to routine operation after successful validation and release. The projects is implemented according to GxP, GAMP5, CFR 21 Part 11 and ISO 14971.

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