Salesforce has become a core platform for managing clinical, safety, regulatory and quality processes across life sciences. But as business teams build applications, workflows and integrations at scale, the challenge becomes clear: how do you maintain GxP compliance while still moving fast?
This whitepaper presents a practical Computer System Validation (CSV) approach grounded in GAMP 5 principles, purpose-built for organizations using Salesforce in regulated environments. It explains how companies can balance innovation, agility and compliance — without unnecessary documentation burden or validation delays.
Whether you are building a new Salesforce application or upgrading an existing one, this guide offers clarity on how to design and validate processes, ensure data integrity, and maintain ongoing compliance.
What this whitepaper covers:
• Applying GAMP 5 to Salesforce development, enhancements and change management
• The difference between validating a platform vs. validating configurations and workflows
• How to manage GxP risk while enabling rapid innovation and user-driven enhancements
• Best practices for documentation, testing and traceability across the full lifecycle
• How to handle system releases, hotfixes and continuous updates on Salesforce
• Strategies for long-term compliance through governance, monitoring and automation
• A blueprint for operationalizing CSV on Salesforce without slowing delivery
Who this whitepaper is designed for:
• Clinical, Pharmacovigilance and Regulatory IT teams
• Quality Assurance / GxP Compliance teams
• Salesforce Platform Owners and COE leaders
• Software Validation and Documentation teams
• Digital Transformation and Innovation teams in life sciences
Why this whitepaper is relevant right now:
The demand for rapid digital transformation continues to grow, but so does regulatory pressure. Companies that treat compliance as a blocker lose time and competitive advantage. Companies that treat compliance as a built-in operational function deliver innovation faster, with higher reliability and lower long-term risk.
This guide provides practical steps to modernize validation practices while preserving compliance, product quality and patient safety.
Download the whitepaper to learn how a GAMP 5-aligned CSV strategy enables compliant, scalable and innovation-friendly Salesforce operations across life sciences.
