As regulatory and technical experts, we support you through various project regarding data lifecycle management whatever the medium (paper, electronic, sample, specimen) such as:
- Current situation diagnosis
- Data organization design
- Risk analysis
- Quality documentation drafting
- Regulatory archiving processes and operation implementation
- Electronic archiving solution implementation
- …
We also offer an annual follow-up service to enable you to remain at the forefront of regulatory compliance in terms of data lifecycle management.
For activities that would require a third party, we have a selection of qualified partners to work with us on our projects.
All these activities are performed in compliance with national and/or international regulatory requirements, in particular GxP, quality standards, as well as best practices in records management.