Tag | trial master files

In both a paper and electronic TMF environment , massive challenges delay the successful development, management and monitoring of an inspection-ready TMF. In this Pharma interview Martin Thorley , TMF Content and Integration Lead at Pfizer, shares his key considerations to make when implementing an eTMF system and the key implementation steps that impact eTMF inspection readiness.

Pharma IQ: 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 Pharma IQ: 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 Pharma IQ: When implementing an eTMF system, what were the top 3 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. [inlinead] Pharma IQ: What does a typical timeline look like to achieve a fully integrated eTMF system and how would you classify the different stages in implementation?

Utilising enterprise business analysis there will be several components to the development of the program and hence implementation. As a priority the process and resource model is to be defined prior to the technology to achieve the process. At the point of implementation it will very much depend on the size of the portfolio and the number of ongoing programs and studies. The bigger and more complex the portfolio the better it is to run a phased approach. Test the process and system with a small number of relatively simple studies before expanding the usage of the system/process. Extensive consideration needs to be given to how ongoing studies will be handled. Will the studies continue in their existing environment or will a migration program be implemented? Therefore, the timeline for implementation can vary depending on many factors. Also, need to factor in the time it is going to take the organization to learn, understand, adopt, and embrace the new process and new system. Pharma IQ: 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 achievable 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 Pharma IQ: 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 Have Your Say Rate this feature and give us your feedback in the comments section below

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