Laboratory computing and process consultancy in accordance with GxP

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.