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By Steve Huggins
There are many advantages to this moving to a Validated Statistical Computing Environment (Validated SCE), including simplifying regulatory compliance. When considering this move we suggest you carefully plan ahead to ensure a smooth transition, reduce any downtime, and limit any data vulnerabilities along the way. Our team have guided a number of organisations from the pharmaceutical world to move or evolve their analysis to a suitable Validated Statistical Computing Environment.
Drawing on experience with Pharmaceutical Organisations, CROs and Biotech’s we have put together our top 5 things to consider when moving to a Validated SCE.
Top of the list (of course) is regulation!
One of the primary drivers for moving to a Validated SCE is to simplify the process of ensuring compliance. The onus is on your business to comply with regulations such as FDA 21CF11 and GxP. In practice this means that your Validated SCE must be put together with regulation in mind. This starts with a clearly documented set of requirements, which will form the basis of all the following tasks. Based on the requirements the SCE must be rigorously designed, implemented, tested, and documented. At all stages it’s essential that regulation is at the forefront. Ultimately, all the evidence must be collated and clearly presented – this provides the Validated in Validated SCE. This is not the end of the story, in order to maintain the validated status, there must be procedures in place for usage and maintenance of the platform going forward.
Where computers are involved security is a priority, this applies to every industry but pharmas hold a lot of sensitive data, making this even more critical. Data security applies to many areas, at the most basic your Validated SCE must be secure from intrusion (that’s a given). Looking deeper, there’s a need to have a very clear and robust security model in place to ensure that staff within your business only access the data they are supposed to. To achieve this, you must plan ahead, understand the different roles within the business and what access they need. Plan how you are going to organise your data and assets, what hierarchies will be needed, and how access should be implemented. Lastly, don’t forget about the procedures: rigorous procedures governing the allocation and maintenance of permissions are essential, as are procedures around data management.
The other side of security is ensuring that you don’t lose your data. A Validated SCE needs to be properly backed up, ensuring that data is recoverable in the event of a loss of infrastructure and can be retained as required by the regulation. Another consideration is the resilience of the platform, there are many options for resilience and highly available platforms but as with all things these come at a cost. A clear understanding of the required backup and recovery timescales will enable you to find the right balance.
Procedures really do deserve their own heading, so here we go. A Validated SCE is more than just a set of secure computing resources, to maintain and evidence the regulatory requirements you are going to need a set of working practices that describe and govern how you use and maintain your Validated SCE. These cover how the platform is designed, built, maintained, and managed; how users interact with the platform; and how data is managed within the platform. These procedures need to mesh with your existing processes as part of a coherent set of standards.
4. Software and Configuration
You are of course going to want to use your Validated SCE for studies, so you need to have a clear idea of the software you want to use. Firstly, there’s going to be the set of statistical tools such as SAS, R, and Python that are the bread and butter of the work you do. But don’t forget the other tools that assist along the way, covering: version control, data transfer tools, and many others. It’s not just software, the Validated SCE will need to be connected and integrated with your other systems. Maybe you choose to use a cloud based software as a services (SaaS) solution, this needs to be integrated with your other systems and things like access and authentication need to be organised. This all leads back to planning and design so, before making any move to use a Validated SCE, ensure all of these requirements are clearly defined and understood.
5. Training and Support
So, you have a shiny new Validated SCE, it’s been tested, documented, and fully validated. It’s ready to go. Remember the importance of training, in order to get the value from your platform it’s essential that users are trained in how to use it effectively. This isn’t just about using the software, there will be processes and procedures that must be followed to get the most out of the platform. Lastly, there’s support and maintenance – it is essential that proper support is provided. This includes, support for technical issues, support so users get the most out of the platform, and support for ongoing maintenance. This last point is very important for a Validated SCE, when the time comes to update and patch the software and infrastructure of your environment there will be additional measures to ensure that it maintains its validated status.
While these 5 points cover the main things to consider when looking to establish or evolve your Validated SCE we understand that everyone has their own specific needs. We know from experience that there is no one size fits all, which is why we don’t have off the shelf solutions.
If you are thinking of adopting a Validated Statistical Computing Environment, or want to explore the benefits this will bring, reach out to us. We would love to help you understand the benefits and challenges and guide you on your journey. Ultimately, we can help you get real value from the right solution.