Can a software system provide the key to inspection readiness? In this interview, Pedro M. Lledo, physician and clinical technology expert, talks to Ken Lownie, Life Sciences software specialist from Agatha Inc., about how evolving beyond paper-based processes and adopting an Electronic Trial Master File system (an eTMF) help ensure inspection readiness.
Pedro: Let us talk first about the concept of inspection readiness – how did it change in the last years?
Ken: The biggest change is that it went from an idea and an ideal to a reality and a requirement.
10 years ago, the approach for many organizations is that they would deal with an inspection on a responsive basis. For example, when they became aware an inspection was coming, they would review their files, clean up everything, make sure all the documents are final, in the right place, and organized and ready to be viewed.
Everyone recognized that is not a very good practice — it wastes time and creates unnecessary work — , and people talked about a better approach, which would be to maintain a state of inspection readiness at all times. But that was more of an idea and an ideal and not the common practice.
Today inspection readiness is an achievable goal and is in fact a regulatory requirement. Since inspection readiness means that you keep everything organized and clean continuously, we can leverage automated systems to enforce defined processes and maintain that state of readiness.
So inspection readiness is achievable now, and it is also a requirement now. In ICH GCP definitions, specifically in the E6 section, it says you must maintain your TMF in a state of inspection readiness.
So now you can do it more easily, and you have to do it. That is a big change!
Pedro: How can the eTMF system contribute to inspection readiness?
Ken: The key to answering that question is to understand that an eTMF application is not just a place to put the TMF files. An eTMF is a process management system and enforces the process of creating a document, naming it, reviewing, and approving it as well as processes for monitoring the state of the TMF.
So, an eTMF ensures that all the TMF content is in a state of inspection readiness at all times.
It is not that you cannot manage a TMF manually but maintaining inspection readiness is really challenging without some kind of process management system to monitor activities and catch issues as they happen.
Pedro: Are you saying you really need an eTMF system to ensure inspection readiness? Or can you do it without it?
Ken: I am almost saying that. The only exception I would make is a small organisation, such as young biotech or medical device company. That might be a venture-backed firm, very young and doing its very first small study. I could see them maintaining a state of inspection readiness simply through strict process management and tracking.
But as soon as you are on many sites, multiple studies and lots of users contributing documents, I really do not see how to do it without an eTMF. Without a system checking every item as it is added to the TMF, you inevitably build up a backlog of mistakenly named, versioned and categorized artifacts.
Pedro: TMF management systems have been available for a long time. They have evolved, and in the past few years there have been a lot of new eTMF systems appearing in the market. Taking a look at all the available systems, which are the main differences between all of those eTMF systems?
Ken: For me, the differences between the vendor solutions today are less about features and capabilities, because there is an understood set of functions that any eTMF application must address. It is more about other factors such as:
- Usability – prior generations of systems were designed for specialists, acting as document managers. Today you should ensure you have an easy-to-use system to ensure adoption by all types of users
- Ease of implementation – the prior generations of eTMF systems sometimes took not just weeks but months or even a year to go from project kick-off. Today a system should be in production in a matter of weeks.
- Price – prices for these kinds of systems are much lower now. This factor makes it possible for much for smaller companies to acquire eTMF applications
Pedro: What is the role of company processes when it comes to using the eTMF system for ensuring inspection readiness?
Ken: That is a great question, because it is easy to think that a software application somehow automatically solves a need, when in fact it is always the case that people, and process are critical.
That means that the implementation of any new system, including an eTMF, is not just a matter of installing an application. It is a project that affects processes, people and other systems, and if these factors are not addressed, the risk of an unsuccessful implementation goes up enormously. But you know more about that than I do, so let me ask YOU a question :)Who should be involved in the eTMF project? Which people, and in which roles?
Pedro: As many roles as possible. Such systems are used globally at the company and all departments and teams should (at least) be aware of what is going on.
That is why it is also extremely important to conduct training across a broad set of roles. The training sessions should include defining the new processes and to come up with the list of new SOPs to be prepared.
My advice will be to involve all the stakeholders and define the champions in every group – the people who believe that the new system will really help everyone to succeed.
