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
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. When a system is vendor-hosted, the validation work does not go away. It shifts. Instead of focusing mainly on internally managed infrastructure, the company has to
In today’s digital biotech environment, labs and manufacturing sites rely on a complex network of interconnected systems: LIMS, QMS, MES, ERP, CDS, eBMRs, data historians, and analytics platforms. While each system may be validated independently, the movement of data between them is where the highest risk now lives. Regulators increasingly expect organizations to demonstrate end-to-end
Background: A Late-Stage Biopharma Preparing for EU Commercialization A mid-sized U.S.-based biopharmaceutical company was preparing to commercialize its first biologic product in the European Union. As part of its global expansion strategy, the company initiated a technology transfer from its U.S. clinical manufacturing facility to a commercial EU site (located in Ireland). While the company
Turning Supplier Audit Files into Actionable Insights for a Mid-Size Biotech Introduction A mid-size biotech organization with approximately 600 employees and a single GMP manufacturing site faced a common challenge: hundreds of supplier audit reports, self-assessment questionnaires, and CAPA summaries stored across multiple folders, but no easy way to extract trends or prioritize risks. The
Client: A Biotech CompanyIndustry: Life Sciences / Pharmaceutical ManufacturingSize: 150–200 employeesEngagement Type: Full-service contract staffing partnershipPartner: Assurea Background A rapidly growing biotech company specializing in cell and gene therapy recently secured Series C funding to expand its manufacturing capacity. The organization planned to establish a new biomanufacturing site in New Jersey, aimed at scaling production
The FDA has finalized its Computer Software Assurance for Production and Quality System Software guidance — a long-awaited update that signals the end of “business as usual” for software validation in regulated industries. For decades, Computerized System Validation (CSV) has been the framework life sciences companies relied on. While it provided structure, CSV often created
Background A mid-sized U.S.-based medical device manufacturer was preparing to initiate a clinical trial for a new Class II device. The company needed additional Clinical Research Associate (CRA) support to oversee trial sites, ensure protocol compliance, and meet regulatory expectations. With limited internal bandwidth and a fast-approaching study start date, the client turned to Assurea’s
Scenario & Background A mid-sized biotech company developing a novel oncology cell therapy was running multiple Phase II trials across different sites. The company’s internal safety team was overwhelmed by the volume of adverse event (AE) reports and needed support in: However, the client did not want a new IT platform or continuous system integration.
Client: Mid-sized biotech company developing novel biologics.Industry: Biotechnology / Life SciencesPositions: 2 QA Specialists and 3 Validation Engineers Background A biotech company was advancing a promising therapeutic candidate through clinical studies toward commercialization. To meet FDA submission timelines, validation of their GMP manufacturing and QC lab equipment and systems had to be completed within six