Understanding CSV: Essential Deliverables for System Validation

What is Computer System Validation (CSV)? CSV is a structured process that documents and tests GxP computer systems to ensure they meet predefined specifications and regulatory requirements. This involves rigorous testing and documentation to demonstrate that systems are installed correctly, operate as expected, and produce reliable results. For biotech and pharma companies, CSV is crucial

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Understanding GxP and ERES Requirements Applicability for Computer Systems

For FDA-regulated pharma and biotech companies, computer systems used in GxP environments must adhere to Electronic Records and Electronic Signatures (ERES) requirements, as governed by FDA 21 CFR Part 11 to ensure data integrity, product quality, and patient safety. Computer systems that create, modify, maintain, archive, retrieve, or transmit records required by GxP regulations (e.g.

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Women Leading Validation Podcast: Assurea

Dori Gonzalez-Acevedo CEO of ProcellaRX interviews Assurea’s Co-Founders, Tanya Sharma and Krisha Patel on the Women Leading Validation Podcast. They discuss their entrepreneurial journeys and share the Assurea story. They also share their perspectives on the current challenges and barriers in the biotech industry around digital compliance and the adoption of novel technologies. Listen to

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Integrating Data Integrity Requirements into Quality Management Systems

Data integrity translates into the consistency, completeness, and accuracy of data. It is required in all aspects of biopharmaceutical development and manufacturing, including emerging technologies like block chain, as you introduce them into your Quality Management Systems. Consistency, standardization, and traceability are some of the many issues we face when it comes to data integrity. Once

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