Life Science Practice

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Cornerstone Life Science Practice Overview Life Science Practice Confidential 1 Life Science Practice – Expertise and QMS Cornerstone has an established Life Science Practice that consists of a dedicated Quality and Risk Management organization that is staffed with industry expertise, a well-defined Quality Management System (QMS), and a Software Development Lifecycle (SDLC) that has integrated applicable GxP components and operational control processes. The Quality organization reports independently of IT or the Product team. This positions Cornerstone to meet or exceed applicable industry regulations and best practices for our SaaS offerings. These processes are primarily driven by our Life Science partners, but positions Cornerstone well within regulated industries as a whole. Below are key highlights: • We have a globally positioned team with over 100+ years of Life Sciences and regulated industry expertise, • We have a well-defined Quality Management System (QMS) with an overarching Quality Manual, • We conduct a quarterly Quality Management Review, including metrics and trending, to ensure overall effectiveness of the QMS, • We have an SDLC and associated process documents (e.g., Policies, SOPS) to align with industry regulations and best practice to incorporate a GxP lens, • We have processes for supporting client audits that include a Client Audit Management SOP, CAPA SOP, and internal Audit Playbook, • We have clearly documented EU Annex 11 and 21 CFR Part 11 Controls document that: o Incorporates the requirements into our overall validation and provides our technical and procedural controls for these two regulatory components, • We manage change for each quarterly release via a robust Validation Change Log to assess and document impact to our baseline validation and associated validation deliverables (e.g., VMP, Software Functional Specifications, Traceability Matrix, Configuration Workbook Template, Validation Test Cases and Validation Test Runs, Validation Summary Report, etc.).

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