In our last post, we heard about a troubled manufacturing campaign where intermittent batch failures cost the company >$1M per batch. One remedy was to capture batch data at the Point-of-Use (POU) and make it available to AI/ML engines for real-time analysis. This capability is typically provided by Electronic Batch Records (EBR). But EBRs are costly and require specialized skills.
What if you could turn your existing Microsoft Word documents into EBRs? With 1Platform4® Manufacturing, you can. Microsoft has recently added features to their Office 365 suite that allow real-time collaboration. BioIT Solutions has leveraged this into an easy-to-use EBR technology. Now EBRs are accessible for emerging biotech companies; a market segment that has previously been priced-out and skilled-out of this vital capability.
The process starts by embedding “smart controls” into the master document and associating them with specific process parameters. For instance, you can define a control as an equipment asset id, a material lot identifier, or a process value such as pH, or dissolved oxygen. The master document is used to issue executable documents for specific process runs and lot numbers. The manufacturing group can then enter data into the executable document and the data is sent back to 1Platform4® Manufacturing for validation and storage. All values are audited to ensure 21CFR Part 11 compliance. There’s even a formula feature that allows complex calculations based on entered values.
The BioIT EBR is currently in beta test and will be certified for commercial availability in 1Q 2025. If you would like to participate in the beta testing program, please contact us at sales@bioit.com. Participating companies will receive early access and substantial discounts off the annual license.
