Moving from paper to digital sounds simple. Replace paper records with a digital system. In practice, there is much more to it. A laboratory may replace paper worksheets with a Laboratory Information Management System (LIMS). Manufacturing may move from paper batch records to an MES or electronic batch record (eBR). Quality may move deviations, CAPAs
How AI powered analysis can help manufacturing and MSAT teams understand batch performance, yield, quality, investigations and technology transfer using data they already have Biopharma manufacturing teams already collect a lot of data. Batch records. Process parameters. In-process testing. Yield and recovery data. QC results. Deviations. Development reports. Tech transfer documents. The challenge is often
How historical AAV manufacturing data can uncover process optimization opportunities and help Process Development and MSAT focus their investigations AAV manufacturing generates large amounts of data across manufacturing systems, process historians, batch records, in-process testing and QC laboratories. But the data is often reviewed one batch or one system at a time. That makes it
A growing biotech company wanted to answer a practical manufacturing question: Why are some batches taking longer than others? The information needed to investigate the question already existed. Manufacturing information was in the Manufacturing Execution System (MES). Process conditions were captured by a historian. Laboratory results were in the Laboratory Information Management System (LIMS). Quality
A biotech company may already have the data it needs to answer an important question. The problem is that the answer may be spread across five different systems. Consider one batch. The MES knows what happened during execution. The historian captures process conditions. LIMS contains laboratory results. The eQMS holds deviations and investigations. ERP contains
We’re excited to announce a new partnership between Assurea and Seeq to help pharma and biotech organizations adopt Seeq for Pharma within GxP-regulated environments. Assurea will serve as the implementation and validation partner for Seeq. As part of the partnership, Assurea has developed a validation package for Seeq that combines Assurea’s expertise in CSV and
In pharma and biotech, digital systems rarely stay the same after they go live. Workflows change, users increase, integrations are added, suppliers release updates, and the system becomes part of a larger operational environment. The real challenge is that oversight does not always evolve at the same pace. A system may still be validated, documented,
27 periodic reviews. 650+ documents analyzed. One clear view of system health. Periodic reviews are intended to answer a relatively simple question: is this GxP system or piece of computerized equipment still operating in a controlled and appropriately validated or qualified state? Getting to that answer is rarely simple. A reviewer may need to look
We’re excited to announce a new partnership between Assurea and Runtime Verification! As software becomes increasingly critical to medical devices, SaMD, and artificial organs, companies need stronger ways to demonstrate that their software is safe, reliable, and ready for use in a regulated environment. This partnership brings together two complementary strengths. Runtime Verification brings deep
SaaS and cloud validation is different because the regulated company no longer controls the full technical stack, but it still owns intended use, oversight, data integrity, access, and compliance. That is where many teams misunderstand the real validation challenge. When a system is vendor-hosted, the validation work does not go away. It shifts. Instead of