Product recalls happen. In the past year, we’ve had two clients that have had suppliers notify them of material deficiencies. In both cases, the companies took the necessary steps to identify the affected lots and to ensure the affected materials were pulled from circulation. The difference is that one customer had used an electronic batch record (EBR) to establish a digital thread spanning the entire production process while the other was using paper batch records. The contrast was stark.
The manual customer had to transcribe material lot numbers from the paper records into an offline Excel spreadsheet. Since the material in question was a common component, it was used in multiple products including buffers and media. Any resulting products then needed to be found, quarantined, and disposed of. This process took several days and multiple analysts and materials personnel to complete.
The digital customer, on the other hand, was able to quickly assess the affected products using a “Where Used” query. Then, each resulting product’s Lot Trace Tree could be traversed to ascertain the affected materials including intermediates, drug substance, and drug product. Luckily, this analysis was accomplished before any of the material had left the building so more costly remediation was averted.
When we work with customers to assess the digitization business case, we often find that the day-to-day transactions only produce modest efficiency gains. Afterall, writing on paper is quite efficient. When comparing paper batch records to their electronic counterparts, you often find that EBRs introduce more operational drag when compared to paper. But when you evaluate the second order capabilities that EBRs enable, such as investigations like product recall exercises, that’s where the real benefits begin to stack up.
Let 1Platform4® Manufacturing be your “Digital On-Ramp”. We’ve helped dozens of emerging biotech companies digitize their operations. Email us at sales@bioit.com or fill out your contact details in the form below for more information.
