Implementing a Robust eTMF System – What to Consider
In both a paper and electronic TMF (trial master file) environment massive challenges delay the successful development, management and monitoring of an inspection ready TMF. In this exclusive Pharma interview Martin Thorley TMF Content and Integration Lead at Pfizer, shares his key considerations to make when implementing an eTMF system and the implementation steps that impact eTMF inspection readiness. Thorley also reveals his key lessons learned after implementation.
Q: What factors drive the move to a robust eTMF system?
eTMF to eTMF
· Content dispersed across
multiple systems potentially leading to lack of control of content and process,
duplication of content between systems, lack of ownership/accountability for
content being in the TMF and lack of consistency
· Ease of access for global workforce – accessibility from any location
· Effective and yet flexible security model to allow access on a user role basis.
· Ability to simply and effectively integrate with other systems and infrastructure
Paper to eTMF
Ability for accessibility of TMF content by a global workforce
· Allows flexibility of accessibility of content when outsourcing operational activities
· Facilitates the process for reduction in paper production and potentially allows appropriate paper destruction. Destruction where there is a valid and robust process for ensuring the electronic image of the paper is true and accurate
· Documents can be processed into the system from anywhere. Remove the need for paper to be transported to central location
Q: What are key considerations to make when implementing an eTMF system?
· A simple but effective
process with quality built in by using quality by design methodology. Ensure
that controls are in the correct places within the process
· Clear and explicit user requirements to ensure the system will align with the process
· A strong governance structure and buy in from all stakeholder lines
· An effective change management methodology
Q: When implementing an eTMF system, what were the biggest challenges you encountered and how have you overcome them?
eTMF is not earth-shattering technology. The biggest
challenges are related to business change management including:
· Obtaining buy in from all stakeholders and functional lines. This requires an approach to influence the lines top down and bottom up. Implementing an effective change management methodology with change agents in each line helped with the dissemination of information
· Having a robust and detailed change management and communication plan. This requires a thorough assessment of the magnitude of the change to understand how/where it is going to impact the organization and engage with committed ‘change agents’ from functional lines
· Planning and timing the transition to the new system. It is essential to align the timing of the transition with business continuity and steepness of the learning curve.
· Setting a clear strategy for migration and developing a clear plan on the operational implementation. A strong process to ensure consistency of migrated content. Constant review of the process and progress to assess if the plan is still applicable and calibrate where necessary.
Q: What do you consider to be key implementation steps that impact eTMF inspection readiness?
Implementation of process controls and measures – be pragmatic with what is
· Ensuring the process controls work by having implementation performance measures that include a review of the outputs to answer the question ‘does the process and the system deliver a TMF that is inspection ready?’
· Don’t be afraid to stop the process if there are any serious concerns – stop, assess, design, execute and control
Q: After implementation, what were the key lessons learned and would this knowledge have impacted your initial implementation strategy?
· Process design first
using quality by design at every opportunity. This is built with the end
customer in mind (retriever of information such as inspector or auditor)
· The needs of users who contribute content to the TMF should be taken into account when developing the business process and technical solution. However, those contributors may be the loudest voice in many organizations, and it is critical to ensure that those needs do not compromise the quality business process
· Be clear on user requirements and remove any scope for assumptions to be made when developing a technical solution
· Migration is very costly and a different strategy might have been implemented if we knew what complexities it would entail
People also read:
Avoiding Critical Findings in your TMF - read here
Implementing an eTMF system is something which will be expanded on by speakers at Septembers TMF & Inspection Readiness Forum with further sessions such as the below:
Assuring regulatory compliance by implementing a centralised TMF oversight strategy
Matilde Jo Allingstrup, Competency Development Professional, Novo Nordisk