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Laboratory computing and process consultancy in accordance with GxP

Project duration: 8 months

Brief description

A medium-sized laboratory is supported by the documentation and validation of computer, measurement, and laboratory systems in accordance with the FDA/GxP standard, so that they can subsequently be audited. An action list is created for this purpose. The existing laboratory architecture and the laboratory processes are systematically documented, simplified, and automated.

Supplement

Initially, the quality system, existing documentation, and actual processes will be analyzed and an action list created, which defines the content, time table, and responsibilities of the project. The advisory activity includes the introduction of a development and testing environment including source code and error management, the creation of a role-based authorization concept, and backup and recovery concept, and an archiving concept, a standard software selection to ensure revision-safe document and file management and the preparation and provision of training courses. Work instructions (SOPs) and templates with formulas and macros (VBA) will be developed, which, along with laboratory planning and device control, also permit the printing and scanning of 2D barcodes. In addition, a VB .Net-based individual software for monitoring GxP-relevant computer systems and data (cross-system audit trail) will be developed. A steering committee was established and moderated to monitor and control the progress.

Subject description

Action list and computerized system equipment (incl. ERES-assessment, documents, and tasks checklist) form the basis of the project and validation planning. The project implementation and documentation meet the requirements and regulations from GMP, GLP, GAMP5, CFR 21 Part 11 (ERES – Electronic Records and Electronic Signatures), CFR 21 Part 820, CFR 21 Part 58, EN ISO 14971, as well as DIN 25 448 / IEC (60)812 (Failure Mode and Effects Analysis). A process-based risk management is performed with the aid of the FMEA (Failure Mode and Effects Analysis) methodology. The development is managed with SVN and Visual Studio. The GxP-compliant validation and documentation of the Excel templates (VBA and formulas) is supported by PUP. The data exchange between the system and laboratory devices (label printer, pipetting robots, flow cytometer, PCR thermal cycler, gel image software, plate reader) is carried out using standard formats via protected and backed-up project directories.

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