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