Validation of Computer-based Systems

Another area of solveno’s competence of is the (re-) validation of hardware and software according to GAMP 5 (Good Automated Manufacturing Practice).

Based on these rules and standards we develop – in close cooperation with you – the user requirement specification (URSS) and create appropriate validation and project plans. Then we perform the phases of validation (eg. Installation Qualification (IQ), Operation Qualification (OQ) and Production Qualification (PQ)) following these developed test specifications and protocols. We analyze and assess the risk situation and prepare internal and external audits with you. We also create Standard Operating Procedures (SOPs) and train your staff in dealing with it.

solveno provides professional support throughout the whole validation cycle in order to comply with the acceptance criteria of the pharmaceutical industry and the requirements for regulated pharmaceutical activities. At the same time, your company benefits from validated quality management and confidence in all audits.