IDBS Blog | 30th November 2023
How to get more insight and value out of your Electronic Batch Record data with PIMS
By Ken Forman, Lead Product Manager, Manufacturing, IDBS
I am sometimes asked to justify where our IDBS PIMS platform (PIMS) sits within the ever-increasing ecosystem of manufacturing software like MES, Historians and Electronic Batch Record (EBR) software. My answer is it depends. It depends on what capabilities your choice of Electronic Batch Record (EBR) software has, whether you can fully leverage your electronic batch record data, or whether you want something that gets you critical data for making critical decisions at a fraction of the time and cost.
In this blog post, I will outline how PIMS can work synergistically with your existing Electronic Batch Record (EBR) software and why PIMS is a lightweight, low-cost, fast-to-implement alternative to consider.
If you are new to Electronic Batch Record (EBR) software, learn more: Electronic Batch Record: Maximize efficiency and compliance.
Get more insight and value out of your EBR data with PIMS
The most crucial difference between PIMS and most Electronic Batch Record (EBR) software is that the latter records batch data but doesn’t analyze it.
For example, I want to analyze and graph my CPP1 (critical process parameter 1) over the past 30 batches to demonstrate I was within PAR (proven acceptable ranges) for these batches. This is not possible in most Electronic Batch Record (EBR) software whereas it is automated in PIMS. PIMS can be set up to connect and query the EBR data (or EBR / batch data can be imported via a spreadsheet or even be manually transcribed when needed) and its built-in analytics and graphing capability can display the comparison at the press of a button.
Another major difference is that EBR data is typically captured and reviewed only on a batch-by-batch basis. PIMS captures batch data in a process-centric, contextualized data backbone that enables easy comparison of data across batches. Why does this matter? Here is where I’m going to take you on a deeper dive into the parts of manufacturing that many of the manufacturers I speak to are struggling to manage with Excel and associated manual processes. And where we have seen the biggest gains in our customers that have implemented PIMS.
- Improved process control: Producers of commercial products must demonstrate to the regulators they’re in control of the manufacturing process. In simple terms, this means demonstrating batch-to-batch consistency and frequently takes the form of Continued Process Verification (CPV) and Annual Product Quality Review (APQR) reports. Since PIMS can query critical data stored in the Electronic Batch Record (EBR) software and analyze it across batches, it will speed up CPV and APQR reporting and automate process control.
- Faster process optimization: Once EBR data is queried for analysis across batches, process optimizations such as improvements in manufacturing yield are simply a matter of statistical analysis. PIMS has such statistical analysis tools built-in, enabling the manufacturing manager, MSAT engineer or product subject matter expert to work independently, without reliance on ad-hoc solutions being developed by in-house data scientists. Furthermore, if ad-hoc work is required, PIMS’ queries of your Electronic Batch Record (EBR) software would generate an easy-to-leverage, organized database that centralizes critical data for all batches associated with a product… meaning direct access to critical data without needing IT to retrieve it. In addition, PIMS data is easily available to statistical tools such as Statistica and JMP so you can benefit from any investments you have made in these tools as well.
- Smoother compliance: Electronic Batch Record (EBR) software can facilitate compliance by enabling operators to proactively identify deviations from standard procedures. Once a deviation is identified, its impact on product quality needs to be mitigated by investigations and potentially corrective actions with the root cause needing to be identified to prevent recurrence. Both corrective actions and root cause analysis are highly dependent on investigating and interpreting data for the impacted batch in the larger context of the manufacturing campaign. Since PIMS can centralize EBR data alongside other contextually relevant data LIMS, historian, ERP etc., root cause analyses can be done in a matter of minutes.
- Better process understanding: While we think of a pharmaceutical product lot as a monolith of information, in practice, manufacturing consists of sequential, smaller unit operations. For example, purification of a recombinant mAb could consist of five unit operations executed daily and sequentially over the course of a week. These will be documented as five individual batch records (paper or electronic).
Subject matter experts need to understand how the unit operations interact to form a larger product batch. A simple, practical example would be knowledge of splitting or pooling volumes from one unit operation to the next. This process genealogy information could be documented in Enterprise Resource Planning (ERP) software or even in the metadata of a well-designed EBR implementation. However, retrieving this information is frequently time-consuming and reliant on manual transcription of the data. Also, ERP systems typically contain PLAN data, but not necessarily what actually took place on the manufacturing floor. This epiphany is critical when looking at “what data is truly meaningful to the question at hand?”
Having a true, real-time understanding of your manufacturing process requires a data management solution that can organize data not just within a unit operation, but across units in the larger context of the process definition, along with data from either paper or other systems that add value to needed investigations. That’s exactly what PIMS does, with built-in genealogy visualizations.
PIMS as an alternative to Electronic Batch Record (EBR) software
Several of our customers are small to mid-sized biotechs or CGT companies in their growth phase. They need to have centralized, contextualized batch data but don’t have a limitless budget to invest in multiple systems. Depending on your requirements, PIMS can be a lightweight, low-cost, fast-to-implement alternative to an EBR system as a first tool on the digital journey.
Many companies prioritize the need to get away from paper for the execution of their standard operating procedures through the roll-out of Electronic Batch Record (EBR) software or an even more involved (and expensive) MES system. However, if you recognize the immediate need is a centralized repository that digitally captures critical process quality data (CQA, CPP, IPC, QC results etc) to speed up monitoring and investigations, PIMS runs in the cloud and can add value to your business within weeks (a modest few months for a full GxP roll-out). This makes PIMS the ideal digital tool to begin your digital journey for a fraction of the implementation time and cost, with the confidence it will continue to add value and scale as your business climbs the digital maturity model. And this is before the ROI of PIMS’ additional benefits are factored in.
Let me finish with a quotation from one of our customers that I believe illustrates the benefits that PIMS can bring to your batch record requirements.
“We needed an easy way to democratize process data for everyone to understand what was going on, from PD scientists to executives. Having data readily accessible and avoiding batch record data mining was important. There just isn’t another product out there that fit our needs like PIMS did.” – Associate Director of Manufacturing Sciences, AAV viral vectors manufacturer.
If you liked this blog post, read more from Ken Forman.
About the author
Ken has spent over 30 years in product, project and IT operations leadership focused in the software and life science industries. Prior to joining IDBS, where he focuses on software to manage biopharma manufacturing process data, Ken served as Director, Project Management at BIOVIA.
Previously, he was Director of Commercial Operations at Fischer Imaging and Director of IT at Allos Therapeutics and Genomics.
Ken holds a BSc in Computer Science from Cal Poly and an MBA from the University of Colorado, Denver.