Problem Area Most Software Can't Reach
For a long time Batch Recording software, or Electronic Batch Records (EBR or eBR if you prefer), for GMP regulated manufacturers has been possible only for the flagship sites of the Global Pharma industry creating a digital vacuum for many companies between the ERP and various machine controllers. Typically, this gap is still handled today using paper documents and spreadsheets.
This situation has evolved as historically there have only been a narrow set of products to choose from, and these are typically very powerful and complex systems requiring customisation to meet specific customer requirements. As a result, the budgets, timeframes, and resources required to deliver these systems mean it’s not possible for most manufacturing sites.
Different App and Approach Required
There have been many recent and well documented improvements to software products stemming from web-based, cloud-hosted, highly configurable applications (or Apps). As with all types of enterprise software, those intended for GxP regulated users continue to emerge from the learnings of Industry 3.0 era projects to mould the new solution design and delivery models or GxP Industry 4.0 solutions.
New technology certainly helps, but it will only get you so far. Perhaps the key to successfully servicing this market for ‘4.0’ GxP Batch Record projects is how the tech and delivery models combine, and if this actually realises a faster implementation, reduced validation effort, and ability to leverage XaaS relationships with vendors in-line with cost, regulatory, and corporate constraints.
One of the critical components to successfully fill the market gap for small to medium sized GMP manufacturers, is the ability for companies to handle large parts, or even the entire implementation themselves. This self-servicing removes one of the major contributors to overall cost and time involved when compared to relying on external providers. The installation service is no longer an issue with cloud software, but especially important for eBR is the user friendliness of the tool to build the customers product processes and recipes. Users need the ability to implement learnings quickly by updating and changing these over time. There is little point investing in systems to create and measure data in analytics if you don’t have the ability to quickly react, implement changes, and realise the benefit of improved processes.
This need for an overall package of cost, technical capability, and delivery model is what guides the development of our BatchLine eBR product. We are fortunate to have Factorytalk’s (BatchLine’s parent company) wide range of subject matter and project experts involved to draw on all these inputs to find the right balance. Our solutions team have many years’ experience in implementing electronic Quality Management System (eQMS), EBR, and Manufacturing Execution Systems (MES) projects; alongside complimentary Computer System Validation (CSV), Data Integrity, Digitisation, Quality, and Production consultants.
For more information about how BatchLine does this please contact us.
Digitising Batch Records is becoming easier for GMP Manufacturers
David Holt, Managing Director,
BatchLine & Factorytalk
Why do we need to do CSV for Batchline and what is involved?