Optimizing Veeva Clinical at KCR

Doug Bain, Chief Technology Officer at KCR

KCR was one of the first companies in Europe to use Veeva as a platform for our electronic Trial Master File (eTMF). Back in 2014, we took an adventurous step of digitalizing the flow of documents across our clinical trials. Eight years later and we have expanded our deployments across the Veeva Vault Clinical and Veeva Quality Suite products.

Computer Systems Validation

One of the challenges that we have tackled is the handling of Computer Systems Validation (CSV). Veeva products are updated on a regular cycle of 3 releases per year. Within each release we have a large number of changes across the platform and products that need to be assessed, validated and implemented. Veeva provide early information on the changes with webinars, release notes and validation materials — this is good. However, it still remains for licensee’s like KCR to ensure that their implementation maintains a state of validation.

Organizations can find it challenging to keep on top of the 3 releases per annum. It is not just a case of having new features installed. Each change must be assessed, documentation must be updated, processes changed, configuration adjustments made and validation work carried out. KCR found that more and more changes were going into a backlog and either not being implemented, or worse being implemented without due process.

GAMP 5 (V) CSV Processes

To improve our work methods and throughput, KCR implemented a set of computer systems validation processes based around GAMP 5 and in particular the GAMP 5 V model. GAMP was original built to help support the US FDA’s requirements for Good Manufacturing Practice. Since then, the methods have been applied across a wide field of process optimization areas. For Computer Systems, the guide ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data (Good eClinical Practice) has focused specially on the validation of computer systems used in clinical research. This guide is intended to provide a risk-based approach to validating diverse computerized GCP systems in compliance with applicable regulations.

KCR have taken this guide as a basis, but extended it by digitalizing many of the aspects of validation. Following an ‘assessed risk’ based approach, this ensures that our systems achieve and maintain a validated state for maximum return and right sized effort.

Monthly Release Cycles

KCR switched to monthly release cycles for our Digital Solution Framework (DSF). This framework includes systems from Veeva as well as other trusted vendors. Changing and validating software monthly might seem like an excessive overhead. However, the frequency of change was purposely chosen for a reason. Traditional systems change management occurs very occasionally and causes high levels of disruption. It is not business as usual. Change becomes unusual and difficult to manage.

With monthly release management we have instilled a sense of continuous improvement / continuous change across our teams. This has taken us away from a ‘big bang’ approach that is both risky and disruptive.

To help manage our changes, we implemented a Release and Change Control system — based around a highly configured JIRA software system. This provides a workflow that takes each change through a risk based lifecycle ensuring changes that are ready at the end of a month go into the release, those that are not ready roll forward into the next release.

Rolling release notes are prepared targeted towards impacted users.

Change Control and Validation materials are electronically produced and roll-up together with the baseline validation information to form electronic evidence of CSV.

Not just software validation

One of the questions that has been raised regarding our approach is

‘Surely if you are licensing fully validated software, the work you are doing is unnecessary?’

This is not true.

One of the aspects of the latest releases of GAMP V and our CSV processes is that it recognises the configurable nature of software today. Cloud platform products are now frameworks that are designed to be highly configurable. As such any software that falls into the scope of a configurable cloud platform must be assumed to be highly configurable and therefore require ongoing Computer Systems Validation post configuration.

Just because we use systems that are validated by our vendors does NOT mean that the CSV process is complete when we receive the software.

For KCR, this means we assess, apply and validate changes to our configuration with every change.

Results

Of course, all this work would be in vain if the results were either disappointing or not proven. At KCR, we run on KPI’s. This puts us in a good position to measure the effectiveness of the work we are performing.

One particular KPI is the level of completeness we are able to achieve against expected documents in our Trial Master File processing. KCR works with 3 different TMF models

1. KCR Veeva Vault Clinical eTMF — this is our latest fully configured and optimized implementation of the Veeva eTMF product that follows the monthly CSV change cycle.
2. KCR Veeva Platform eTMF — this is our legacy vault implementation that we first implemented in 2014 and is still used for studies that started prior to the availability of Veeva Vault Clinical eTMF
3. Sponsors Veeva Vault Clinical eTMF — we work with both our own but also our sponsors Veeva Vault Clinical eTMF implementations.

The metrics we have demonstrated are that are able to achieve a considerably higher rate of completeness against Expected Documents on our own highly configured and validated Veeva Vault eTMF platform than achievable with other methods. For further details, see this

These completeness metrics reflect not just the work that we have carried out to optimize, through configuration, processes and validation but also the resulting continuous Inspection Readiness that is achieved.

This article was originally published on LinkedIn by Doug Bain.