Validation according to GAMP 5

Cost effective implementation of an obligatory validation system by means of a risk based approach
To accomplish GxP conform implementations of computerized systems correctly ab initio the GAMP manual (Good Automated Manufacturing Practise) of the international society of Pharmaceutical Engineers (ISPE) established itself as trend-setting.

By publication of GAMP 5 the ISPE has continuously specified the guidelines for the creation and implementation of qualified ERP software and has aligned them even more to the practical requirements. The risk based approach has turned into the center of the manual.

Primary objectives of the new GAMP manual:

• avoiding redundant work especially with closed systems,
• stronger integration of the validation efforts of the supplier – without losing sight of the process qualification,
• inclusion of the fact that most systems are configurable and must be customized during their life cycles,
• as well as the adaption of the “V-model” to the different types of computerized systems.

As a result the FDA risk based approach – yet, cultivated by the YAVEON consultants for years - is confirmed by GAMP 5. A significant advantage for the user is that necessary efforts in a project can be reduced to a minimum. The test documents created during the development of the system are valuable for future validation of the users and therefore prevent unprofitable redundant work referring to the standardized YAVEON industry solution.

Process oriented ERP implementation and validation

The business processes represent the starting point for an YAVEON ERP implementation because only this way a validation of the realization of the processes in the ERP system is possible. Conveniently, YAVEON provides preconfigured SOP drafts (work instructions) and test cases as well as existing documents of the technical and functional specifications for all business processes where validation is obligatory. These then have to be merely customized to the company´s specific demands. This procedure saves time and money and also increases the safety. The YAVEON team members and partners offer consulting in all steps of a process while profiting of their validation experience.

Drafts from A-Z:

• VPP: Sample-Validation Project Plan
• VPR: Sample-Validation Project Report
• URS: User Requirement Specification
• BPML: Business Process Master List
• FS: Functional Specification
• Tests: Template-Acceptance Test, Template-Installation Qualification
• Change Control: Sample Form-Change Request