I was previously (and proudly!) an engineer responsible for pilot plants for one of the top ten Pharma companies, such facilities are where the production methods and techniques for new products are refined from R&D into a robust process for commercial manufacture. I recently had the opportunity to visit my old plants and Happily 🙂 much has been improved! They were much cleaner, a new computer control system had been installed in the automated plant and all the equipment that could be, was connected to a data historian. However, they were still using paper batch sheets to manage and record the production for Data Integrity and GxP compliance. I wasn’t really surprised, as I know how difficult it is to get funding for technology projects in general in large companies and especially in non-commercial production areas. There are a number of factors that work against these investment projects:
- Traditional Manufacturing Execution Systems (MES) are expensive to run and maintain. They have high license fees and the setup and configuration often takes many months and can cost tens, and hundreds of thousands of dollars. On top of this, they are often ill suited to the type of manufacturing done in pre-clinical and pilot plants. If you are only making one, two or three batches ever and those batches are typically small volumes then it is a heavy burden to spend such cost and time configuring the system before it can be used.
- Many of these traditional manufacturing IT systems require 3rd party skilled resources to configure them before the users can start to gain a benefit. It’s no wonder then, that leaders and decision makers, if not the users themselves, rule out these systems or prioritise the investment funds on commercial manufacturing solutions and ‘physical’ process technologies.
The result of these large scale and associated efforts s leaves the development manufacturing people without modern systems and they have to continue to rely on paper and inefficient tools. These people however, tend to be highly educated, driven and resourceful so you will often find one or two individuals whose dissatisfaction with the situation drives them to explore new ways to make life better and easier for them and their colleagues. Word libraries, templates, spreadsheets and older technology that they can develop themselves are all pressed into the service of providing bespoke, almost artisan, solutions to approximate what they know their commercial manufacturing colleagues take for granted. If only it could be different!
Well there’s good news. Advances in technology, lean, agile, cloud computing and the start-up culture has encouraged a number of companies to develop solutions that are breaking the old model of software provision. These new solutions are hosted online as a service, and therefore don’t require much investment in IT infrastructure and that investment is not CAPEX. They are platform based so the basic solution can be validated for GxP and then deployed quickly to the users. They have a no-code configuration and set up approach which basically drives a self-service model for user adoption and set up, and lastly and most importantly they are cheap! Most will compare on their recurring subscriptions with the maintenance contracts for typical enterprise solutions, without a sizable upfront investment and huge savings in operational costs for internal support persons and dedicated infrastructure. So what’s is not to like? Well in terms of functionality they may not provide all the features of a strategic MES solution in your 2billion tablet plant, but if you have plants in emerging market locations, or with volumes that do not create a business case or support the depreciation of a top tier MES then maybe these systems are for you.
Perhaps one of the greatest differences with these solutions is that you can access and explore these systems simply and quickly via an online demo and free-trial sites which current users are finding allow them to replicate their existing batch records and work instructions in days. The same trial site then can be extended into a production pilot often without the need for any vendor side services. If you add in the fact that you can significantly reduce QA review, approval and archival times both in document creation and batch release then it’s worth serious consideration from both perspectives of cost savings and GxP compliance