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Spreadsheet Validation - Myths, Risks and RealityCompanies regulated by 21CFR Part 11 face the challenge of controlling and tracking systems which are often difficult to maintain and validate.Spreadsheet use is one of the most common and often overlooked compliance risks in organizations today, due to their pervasive use, and inherent flexibility. When used to manage regulated information or data used to support GxP decisions, validation is a must.
What does the FDA say about spreadsheet validation?
What are the common pitfalls that organizations experience when trying to validate these systems?
Xybion is the leading provider of software, services and consulting for global corporations operating in highly regulated industries. Our unique solutions focus on regulatory compliance, GRC, quality management, GLP, integrated preclinical lab management, early-stage drug discovery, content migration and systems validation. Xybion specializes in helping companies improve their overall compliance processes and provides a complete view into organizational risk across global organizational models.