By: Amy Adams, Systems Analyst
At AmplifyBio, we understand the critical role data integrity plays in achieving successful outcomes. While spreadsheets are a cornerstone of many businesses, they can introduce errors due to their inherent ease of use and accessibility. This is especially concerning in GxP-regulated environments, where compliance with 21 CFR Part 11 is essential.
To ensure our data’s continued quality and compliance, we’re proud to announce our investment in two innovative tools from CIMCON: eInfotree and XLValidator. These solutions empower us to address data integrity challenges head-on and mitigate compliance risks. While eInfotree enables putting the ring fence of compliance requirements to existing spreadsheets without altering the user experience and minimal training, XLvalidator helps create validated spreadsheets from scratch, generating all documentary requirements to execute IQ/OQ and create the required validation artifacts. These two Excel add-ins further our commitment to delivering high-quality, compliant data as we continue to grow as a company, mitigating quality compliance and data integrity risks.
These innovative solutions not only mitigate quality compliance and data integrity risks but also deliver a multitude of business benefits:
- Reduced Compliance Risk: eInfotree safeguards data with audit trails, e-signatures, and access controls for every wrapped file.
- Seamless Excel Integration: Leverage existing functionalities like CSV imports and automatic Excel conversions to promote a user-friendly, compliant experience.
- Enhanced Efficiency: eInfotree boasts an impressive 80% reduction in QC times, bringing it down from 20 minutes to just 5 minutes per spreadsheet.
- Faster Data Comparison: The built-in workbook comparison tool in eInfotree highlights any changes made to the original file, streamlining data analysis.
- Automated Workflows: Eliminate manual intervention and the need for 100% QC reviews through automated Excel file conversion to eInfotree wrapped files.
- Environmental Sustainability: With eInfotree, there’s no need to print spreadsheets for QC purposes, saving roughly 1,000 sheets of paper per study.
- Simplified Data Sharing: Share eInfotree files with clients alongside a PDF copy of the audit trail for complete transparency.
- Effortless Spreadsheet Validation: XLValidator generates IQ/OQ documentation, saving time and resources.
- Robust Data Protection: Enjoy peace of mind knowing that files, audit trails, configurations, and settings are all stored securely in a database with automated backups.
By implementing these advanced compliance solutions, AmplifyBio demonstrates its unwavering commitment to delivering high-quality, compliant data. This investment empowers us to continue providing exceptional services to our clients while ensuring the integrity of our research.
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