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
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
Many life sciences organizations commonly ask this question when implementing a SaaS platform: “If the vendor already validated the system, what do we still need to do?” The answer is straightforward. The vendor is responsible for the platform it develops, operates, and maintains. The regulated company remains responsible for how that platform is configured, governed,
Defining intended use is one of the most important steps in validating AI and SaaS tools in regulated pharma and biotech environments. The intended use statement establishes validation scope, testing strategy, risk classification, supplier oversight expectations, and procedural controls. For AI systems, this is often more difficult than traditional software because operational usage can evolve
As biotech companies scale, user-friendly software systems—like EQMS, LIMS, or MES— can help standardize operations, ensure data integrity, and support regulatory compliance. But before signing a contract, it’s critical to better understand what the system can do and how it’s built, maintained, and supported behind the scenes. So, how do you dive into what really
Quality agreements are vital documents that outline the roles, responsibilities, and expectations between a company and its suppliers. For pharmaceutical companies, ensuring quality throughout the supply chain is crucial for compliance with regulatory requirements and maintaining product integrity. Here are key considerations to include in a quality agreement for suppliers. Introduction/Purpose/Scope 1. Parties to the
In software development for regulated industries, ensuring compliance with regulations such as 21 CFR Part 11 and EU Annex 11 requires a systematic and structured approach. In this blog, we explore how adhering to the principles of ISPE GAMP® 5, can guide software providers in aligning their activities to ensure compliance. In this blog, let’s
As a clinical startup, establishing a supplier management program and managing supplier relationships is critical to ensuring the quality, safety, and efficacy of clinical products and therapies. A supplier management program defines the standards to evaluate, qualify, monitor, and requalify a company’s suppliers. This program is a holistic approach to ensuring your suppliers meet regulatory