EPM speaks to Ben Saxton, Europe head of sales at Formpipe Life Science about why data preservation is important if firms are to ensure quality and compliance.
Quality
1. Could you provide us with a bit of background about Formpipe Life Sciences and the services you provide?
Formpipe Life Science works with businesses to help them develop, implement and maintain compliance and data preservation solutions to ensure quality and compliance. We simplify complex processes and technology environments to deliver customers’ quality and compliance goals within the relevant regulatory frameworks. Unlike other companies within the sector, Formpipe Life Science’s sole focus is the life science industry, made up entirely of experts with a life science background, allowing us to impart a great knowledge of the sector to companies we work with.
2. Could you highlight the importance of managing quality assurance and compliance within the pharmaceutical sector?
The key focus for all pharmaceutical companies is ensuring the safety of their patients, so managing their quality and compliance is a big step in helping them do that. Therefore, Formpipe Life Science have to guarantee the best ways for these companies to work, with the safety of their patients remaining the top priority. With many firms in the pharmaceutical sector not yet using data to drive their decisions, we view this as an opportunity to help these firms improve. Many of these companies have a huge wealth of data and metrics available to them, but are reluctant to utilise it, so there is a great opportunity for improving their processes to ensure patient safety is remaining paramount.
3. What sort of challenges face companies when they are looking to implement software solutions to manage quality assurance and compliance?
There are two major challenges that companies tend to face when implementing a new quality compliance solution. Firstly, businesses need to find a solution that works within their current work streams and similar to how they want to work in the future. Often, a move to a new system is a chance to review and harmonise processes, but that choice needs to be dictated by the business, rather than the software. Being comfortable with the solution will allow them to maintain their compliance with either existing processes or newly adopted ones.
Secondly, introducing any new software system that has regular users will result in some fear of change within the user community. Therefore, it’s important that a change management strategy is implemented from the top down. Senior management need to provide guidance and clear communication to help the execution of the solution run smoothly. It is likely that the comment “we have never done it like that” will be heard, but companies need to view this as an opportunity to ensure their employees know exactly what is happening, why they are doing so in a specific way and the benefits that will be gained from this change.
4. What advice would you give to companies starting to implement new solutions for quality assurance and compliance to ensure as smooth as possible transition?
One of the first things we advise to companies is to make sure there is clear leadership and ownership over the implementation, making it obvious who owns the project, why this responsibility sits with them and what they are hoping to achieve. This allows for one person or team to take responsibility, whilst clearly communicating the objective of the project to all employees. All employees can provide input and all requirements can be considered but the person responsible needs to prioritise the key requirements of the business, setting a clear direction for the implementation. This then has the potential to be expanded, which is easy to do, but it can be very difficult to shrink a solution.
Also, businesses need to know exactly how they are going to measure the success of their new solution. This benchmark will be used to judge the level of success of the project and will also shape the future growth of the system. This measurement needs to be agreed, defined and managed by a dedicated team or employee.
5. Is there a difference in the required approach to the process of implementing a new software solution depending on the size of the business in question?
Whilst the project itself might differ depending on the company, the actual implementation of the solution should not vary, no matter the size of the business. We apply the same principles to an implementation whether it is a small or a large company. Companies of a smaller scale may find it more beneficial to implement a solution that is off the shelf, whereas bigger organisations may want a more tailored package, but the implementation process remains consistent.
6. Are there any specific regulatory guidelines that companies must take into consideration when looking at software solutions?
Regulation is a massive consideration, especially for organisations within the pharmaceutical industry. When choosing a solution, businesses need to consider everything from FDA, MPA, EU and MHRA guidelines. Formpipe Life Science specifically recommends that companies ensure the solution they choose is a Good Automated Manufacturing Practice 5 (GAMP 5) approved product, regardless of which area of life science the firm is operating in. If the solution is hosted with a provider, then you need to ensure that the environment is life science qualified. Look out for a well-defined set of procedures covering the structure, update and management of the physical and virtual environments. It should also be obvious how the provider ensures staff are correctly trained with a complete training history for those involved.
7. What advantages can companies gain from moving to a software solution for quality assurance and compliance management?
The primary benefit common to all projects will be better use of their existing resource. As customers implement electronic quality management systems (EQMS), they can gain some excellent insights into the business, and can make informed decisions based on the metrics this provides. This can only be achieved once quality professionals have had the administrative tasks taken away from them, to instead be performed by the EQMS. Taking time to make quality led decisions, rather than business administration will bring immeasurable gains to an organisation.