What should you look for when hiring a life science SaaS implementation project manager?
Not all implementation PMs are alike, while many specialize in providing a high-level of quality, he/she may not understand the critical gating and documentation required to ensure your system meets all required validation steps before production approval.
During your vetting process make sure that they meet the following key criteria.
Do they have experience in implementing GxP systems including an understanding of all the required phases and gates that are needed to be part of the effort?
Have they successfully coordinated projects with both internal and vendor quality, IT, and validation SMEs (Subject Matter Experts)?
Are they experienced in using a hybrid approach to implementations?
Focusing on which aspects can be done via an iterative approach and those that require the use of a waterfall SDLC (System Development Lifecycle) in order meet necessary validation approvals.
Can they aid in the development of a RFI (Request for Information) and/or RFPs (Request for Proposals) needed to ensure vendors are following the necessary standards and regulations such as?
ICH Guidelines
ISO standards
Has he/she participated in any IT technical reviews of the vendor’s platform, BCP (Business Continuity Plans) and DRP (Disaster Recovery Plans) and other architectural requirements?
What experience do they have within the clinical space?
These are critical, especially when looking at a CTMS (Clinical Trial Management System) and/or an eTMF (electronic Trial Master File) implementation.
In the life science discipline implementations aren’t successful when deemed ready for production, based on any user acceptance testing, they must meet all regulatory requirements, including documented proof that required SOPs (Standard Operating Procedures) and validation steps were followed. This is the only way to provide a high level of confidence that they are inspection ready for any agency audit.
Want to learn how my experiences align with all the above and more, let’s connect .
Next week’s planned blog – Identifying your key requirements when developing an RFI / RFP for CTMS vendors – Don’t forgot to look at the big picture.