White Paper
Spreadsheet Validation on
Rumors, Risks, and Reality
Learn about :
- What are the rumors and misconceptions as they relate to regulatory compliance?
- What is the primary risk associated with spreadsheets relates to business continuity?
- What is the reality in contemporary pharmaceutical/life-science companies where spreadsheet systems are employed more broadly across organizations, and in greater numbers, than any other category of data creation/collection technology?
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What do you need in a solution for 21 CFR PART 11 Compliance with Spreadsheet Validation?
A cost-effective solution that provides 21 CFR part 11 compliance with minimal system and operator changes records all actions in an independent, secure audit trail.
Must contain comprehensive application security & integrate into your existing security infrastructure, controlling both user administration and access to raw data.
It must be Validation-Ready by offering a comprehensive set of validation documentation templates and SOPs to support the implementation and deployment in highly regulated system environments.
A cloud-based Compliance, Quality & Risk Management platform unified with R&D, Labs, Predictive Risk, Clinical, Manufacturing, and Document Management
- Over 40 Years of Quality and Compliance Expertise
- Awarded by FDA's NCTR for Data Management Software
- By bringing together the best solutions, services, and the most dedicated experts in the industry, Xybion is well-positioned to deliver enhanced capabilities to address enterprise challenges and deliver even greater value to our current and future clients.
- Top 20 Pharmaceutical Companies use Xybion.
