CSV on Change Programs. Help or hindrance A Program Leadership Perspective..
- chris10040
- Apr 29
- 3 min read
As a newcomer to healthcare in 2019, I was blissfully unaware of Computer System Validation. Upon starting my new role as Head of Planning for a national field-based nursing workforce, I inherited responsibility for the Validation of the incumbent Scheduling and Clinical recording system. I had no idea what this meant.
The site’ CSV team, showed me some PDFs I needed to hand-sign, in a certain format, hand to AN Other, then back to CSV, then QA. I was quoted some scary stuff about the regulators and some SOP numbers, linked to annexes......It seemed very pointless and onerous to me. I just didn't get the point in these PDFs, or how these odd words like: master data criticality, VMP, GAMP5, Up-versioned URS, periodic review would keep this (what I now understand to be) GxP critical system up and running any more than good housekeeping would.
Shortly after joining, I was asked by the UK Leadership team to lead their Digital Transformation. In short summary, this involved:
Repurposing ERP to its core functionality (Manufacturing, warehouse, supply chain and finance)
Implementing an enterprise digital platform. Designed by business for the business.
Integrating with ERP (Business core functionality) using Middleware
Creating one digital patient record across HCPs in the NHS, Pharmacy Services, Patient Services, Patients
This led to 2 significant business transformations, for 2 business areas (phases) over 4 years.
CSV was a challenge on Phase 1. I had the usual resource, time, cost challenges, leading to many hats. One hat being Project Validation. As Program manager, I was accountable to ensure a complaint transition.
I read up on the V model. It made sense conceptually, but I still had to relate this to the company's local and global SOPs. The volume of work, the stretched onsite CSV team and my lack of understanding, meant bringing in external help. This is where I learned 2 very different approaches: Autocratic and Consultative.
Autocratic:
The 1st company I worked with adopted an autocratic, command and control, fear-based approach. This approach was one size fits all. It didn't refer to the GAMP 5 risk-based approach and critical thinking and it drove work and negativity into the program. Like any negative relationship, it didn't work out.
Consultative
The 2nd company had a consultative approach and explained more of the ‘why’ and ‘how’. Through this approach, I've grown to understand the V Model and how to apply it. Furthermore, I'm now a huge fan. It's extremely good change methodology and works alongside waterfall or agile projects to protect patients. In doing so, it also protects, you as an organisation or as a program manager.
As a client-side project manager:
Who wouldn't want defined requirements, signed and approved in a version-controlled URS. It forces the business to agree up front on what they want?
The FS gives you as a client the opportunity to ask your supplier to nail their colours to the mast.
The Trace Matrix lines everything up across every phase, so nothing gets missed.
Applying a gated approach ensures readiness to hit the next phase.
Risk assessments, drive better testing.
Then this is all served up in a bow in the form of a TSR and VSR, presented back to the key business stakeholders for a go / no go decision to deploy.
Once I understood the need for approved documents and all this control and traceability, it became a safety net for me as it simply ensures as successful landing. So, for me it’s been a gift. Largely because of the more consultative approach. CSV is critical to Digital Transformation in Healthcare. Proving you’ve validated your project is compulsory and autocratic so those applying it, don’t need to be.
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