Electronic Batch Records (eBR): Translating manufacturing processes into operational excellence.
I’m receiving a lot of interest in paperless manufacturing and wanted to share some considerations for implementation.
The pharmaceutical and life science sector has been governed by strict regulations for many years and few other industry sectors can claim they are regulated as stringently. Recently, we’ve been reminded how fragile the world is and how something we can’t see can wreak havoc on a global scale. The word ‘Biologics’ is now common place on the world stage and the search for a vaccine by the biologic manufacturers has been depicted as a community coming together to accelerate the response (The Chemical Engineer), but it will be some time before a safe vaccine is ready for release. With a vaccine being produced on a global scale, by multiple manufacturers under enormous pressure to deliver ‘the antidote’, how can they follow FDA guidelines and comply with GMP in a fast moving operation?
The key drivers within the sector are well affirmed as: time to market, quality/regulations, flexibility and efficiency. The ability to up-scale from clinical trials of small batches to full production whilst maintaining quality is paramount, but many companies’ quality procedures are paper based which are susceptible to human error. Each company is individual and will most likely have their own reasons for not adopting electronic methods to manage batch records. These are likely to be: established protocols, simplicity of paper based records, minimal investment and minimal training. An electronic batch record solution enables completely paperless manufacturing within regulated processes. It supports operational and manufacturing efficiency in both manual and highly automated environments. The solution can be standalone, or it can integrate at an Enterprise Resource Planning (ERP) level, which provides scalability for a business. Costs are scalable as companies do not have to spend huge amounts of money on hardware, software and training as stage by stage the solution can be implemented. This methodology also addresses an area sometimes overlooked, and that is the adoption and acceptance of the solution by the teams using it. Addressing the human factor by the introduction of an eBR solution in manageable stages allows the stakeholders to ‘buy into’ the process and realise the value it brings.
Value translates into benefits to various people in the business. For example, an electronic batch record system eliminates the need for technicians to fill in laborious paper reports, carry pens and clipboards into cleanrooms. It eradicates the common practice of transferring files to USB pen drives, reducing the security risk whilst addressing the danger of intellectual property falling into the wrong hands.
Siemens Opcenter Execution Pharma encompasses eBR and expedites the design of master batch records (MBR) and the execution, review and release of electronic batch records (eBR). Materials can be monitored, tracked and recorded during production. Reviews are conducted with the help of exception rules that identify and document deviations. The deviations can be processed during operations (review by exception). If something is wrong, it can be investigated, thus saving time and ensuring consistent quality. Digitalisation allows the sharing of data where the batch can be reviewed and authorised by users in the lab or involved in the process elsewhere. Innovations now allow the interaction between production, QA and IT to seamlessly work together, collaboratively by using eBR Apps to review, log and authorise remotely. Reviewing a batch is faster and more efficient than trawling through paper records. A more efficient batch-review process is expected to reduce supervisory and QA batch product review by up to 75 percent and cut management review cycle time by 50 percent (Pharmamanufacturing.com), with another report suggesting a reduction in batch review time from three days to two hours. By implementing eBR incrementally will allow key stakeholders to assess the return on investment for their business rather than rely on previous studies which might not be representative of their business. If funding is an obstacle, then financial solutions from Siemens Financial Services is an option to explore with smart financing solutions.
Companies thinking of going paperless should consider a technology partner. A partner such as Siemens can provide digital consulting to unearth the ‘pain points’ from key stakeholders within the business and create a digital strategy for all to buy into. A team should be assembled from all corners of the business including; General Management, Lab QA, Data Analysts/Scientists, IT and Project Engineers to name a few, who can work with the technology partner to understand how eBR would integrate into their current processes and accelerate the time to market which is so vital today.
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