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What is Computer System Validation?

Explore the intricacies of Computer System Validation. Dive deep into its significance, processes, and best practices to ensure reliable and compliant IT systems in today's digital age.
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Regulatory Compliance Guide for Biotech Companies

How can biotech companies ensure compliance? How is the biotech industry regulated? Why is Compliance Important in The Biotech Industry? Discover what Biotech companies need to stay compliant with governing agencies.
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CSA & CSV: What the Experts Know

Brian Slocum is a Senior Consultant and Project Manager for Arbour Group, a global provider of regulatory products and services for the Life Sciences for over 25 years. He has broad experience with software applications enabling manufacturing, distribution, engineering, quality management, marketing, clinical affairs, and related business functions. Brian also has extensive experience in various software development (SDLC) methodologies and their effective use within a regulated environment. On September 13, 2022, the FDA released draft guidance, for comment purposes only, on Computer Software Assurance (CSA) for Production and Quality System Software. With the draft guidance, Arbour Group presents its subjective opinion.
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Change Control: Fundamentals for the Life Sciences

Why is managing change controls essential to the life sciences? What do pharmaceutical, medical device, and biotechnology companies need to know to meet compliance requirements? Arbour Group’s fundamentals to change control provides useful tips for managing compliance across the end-to-end supply chain.
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Supplier Management & Controls: Fundamentals for the Life Sciences

Why is managing supplier controls essential to the life sciences? What do pharmaceutical and medical device companies need to know to meet agency requirements? There are fundamental tips for defining supplier relationships and meeting your goals as a compliant life sciences organization.
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The Fundamentals of Test Script Development

What is a Validation Test Script, and what does it consist of? Why is it necessary for the Life Sciences validation process? Determine how different test scripts affect various phases of the validation process.
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The Fundamentals of Validation Planning

What is a Validation Master Plan? Why do organizations in the Life Sciences need a Validation Plan? Discover the purpose and benefits of a VMP that leads the validation process.
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The Life Sciences Software Validation Process

Explore the software validation process to maintain compliance with regulatory agencies like the FDA and EMA. Arbour Group breaks down what software validation entails in the life sciences, what deliverables are expected, and the benefits of software testing.
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