Computer
Software
Validation
My knowledge and years of experience within the Validation & Regulatory in the Life Science industry is at your disposal. As board member of the ISPE Community of Practice "GAMP Benelux” and as a consultant / Black Belt, I had the opportunity to increase my skills and became a recognised specialist in Computer Validation and related services.
The following services at a fixed price or hourly basis are available:
- Performing a Compliance Scan (GMP, 21CFR part 11)
- Conducting audits of your suppliers
- Conducting "mock audits” for your business
- The planning and execution of validation activities
- Implementing Lean & Paperless Validation
- Drafting and reviewing project documents and procedures (GAMP )
- Risk Management (FMEA)
"if it does not make sence to you, you probably are doning it wrong"
Paperless Validation
Validation activities of computerised systems used to create a lot of paper to has to be stored for a long time. Recent tools can get rid of this paper trail and still meet the requirements for a validated system.
Using the tools MS Azure DevOps and MR4DevOps I have developed a paperless validtion strategy to validate efficiently computerised systems. I created a White Paper to describe this paperless strategy. With my knowledge I can support new users of MR4DevOps to implement a paperless strategy in their own environment.