ASSURE THE DEPENDABILITY OF THE DATA YOUR SCIENCE DEPENDS ON

From financial processes to laboratory and manufacturing operations, spreadsheets, databases, and other end-user computing applications have become vital to your operations. Your need for scientific accuracy requires dependable data accuracy. On top of that, you need to comply with regulations such as the Food and Drug Administration´s 21 CFR Part 11 and address GXP quality standards while reducing risk and improving business process.

CIMCON can help. We offer extensive experience working with many of the world’s leading pharmaceutical and medical companies to bring their spreadsheets under control to ensure regulatory compliance and reduce costs while improving operational efficiency. Solutions that help you meet FDA 21 CFR Part 11 regulations.

CIMCON Solutions Help You:

  • Assure data accuracy across all EUCs
  • Greatly reduce time needed for validation.
  • Maintain cell level audit trails
  • Implement electronic role-based signatures and other critical security features
  • Save time and money with easy installation and eliminating need to migrate to a new system
  • Minimize staff time required to configure, use and maintain

DESKTOP SOLUTIONS

Security, Cell-Level Audit Trail, and eSignature

  • Excel plug –in to streamline user adoption
  • Secure
  • Cell-level auditing and irrevocable audit trail
  • eSignature functionality
  • Essential for GxP designated projects
  • Helps meet 21 CFR Part 11 guidelines

eInfotree Access Module

  • Acess plug-in to streamline user adoption
  • Irrevocable audit trail
  • eSignature functionality.
  • Designed to help you meet 21 CFR Part 11 guidelines for Access databases used in support of predicate rules.

Spreadsheet Validation

  • Excel plug-in
  • Performs a visual logic inspection of spreadsheets
  • Instantly highlights any errors, warnings or issues
  • Reduces the time and cost of spreadsheet validation
  • Automatically generates specification documents and IQ/OQ protocols for your spreadsheets

ENTERPRISE SOLUTIONS

Inventory, Risk Assessment, and Enterprise Data Lineage

  • Inventory all your EUCs
  • Automatic risk assessment
  • View data flows between enterprise databases and EUCs
  • Identify high risk files

Change Monitoring and Controls

  • Ongoing monitoring and controls
  • “Smart Audit Trail” highlights critical changes
  • Document reviews and signoff

FREE WEBINAR: Ensure data integrity within your spreadsheets

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CIMCON PROTECTS THE WORLD’S LEADING LIFE SCIENCES COMPANIES