Your compliance – our job.
Our experienced project and validation managers know the processes from long-standing practice and proofed their mastery and quality awareness in many projects. We help you to achieve a GxP compliant system documentation of your systems that comply with the rules and prepare you to proof it in coming inspections.
We support you in the crucial steps of the validation process:
- Validation Planning
- Requirements Specification
- Functional Specification
- Design Specification
- Module Specification
- Module Testing
- Integration Testing
- Functional Testing
- Requirements Testing
- Traceability Matrix
- Validation Report
and help you to establish the required documentation for operation and being ready for audits.
Our experiences comprise:
- Electronic Document Management and Archiving (eDMS)
- Laboratory Information Management System (LIMS)
- Pharmacovigilance and Drug Safety Databases
- Submission Tracking Systems
- Enterprise Resource Management Systems (ERP)
- Contract Management Systems
We adhere to the newest GAMP Guides and keep our industry knowledge up to date.
Get in contact, we are here to help.