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
Auditing IT infrastructure in a GxP environment means checking whether the technical foundation behind regulated systems is controlled, supportable, and appropriate for its intended use. The audit should not stop at servers or network diagrams. It should test whether access, changes, backups, monitoring, and supporting services are managed in a way that protects system reliability
Pharma companies cannot rely on standard commercial SaaS contracts alone when regulated systems, GxP data, or AI-enabled workflows are involved. In regulated environments, contracts and SLAs help define operational oversight expectations that support validation, data integrity, cybersecurity, supplier governance, and inspection readiness. Most commercial agreements are designed around uptime and commercial liability. Pharma and biotech
For a growing biotech company, implementing the first major digital system is an important milestone. Paper records, spreadsheets, shared drives, and disconnected tools that worked during early growth may no longer support increasing operational complexity, regulatory expectations, or future scale. The natural response is often to start evaluating software. But selecting an eQMS, LIMS, LMS,
How AI-powered document analytics helps manufacturing teams compare complex documentation, identify process differences, and accelerate technology transfer while keeping GMP decisions under human oversight. Technology Transfer Is Still a Documentation-Intensive Process Successful technology transfer is about far more than moving a manufacturing process from one facility to another. It requires ensuring that manufacturing knowledge is