An Electronic Lab Notebook designed for Compliance

GxP (GMP, GCP, GLP) Compliance

For GxP compliance the SciCord ELN provides an Audit Trail, which features audit records at the spreadsheet cell level for a comprehensive narrative of the initial documentation, subsequent updates, and review.

21 CFR Part 11 Compliance – Electronic Records & Signatures

Review Alerts automatically highlight situations of potential concern. Review Marks focus review on substance differentiating between initial and updated records.

Process Control

Electronic Signatures provides acknowledgment of responsibility at key points of the documentation process.

For labs that are compliant, the SciCord ELN provides a bit of peace of mind that if an auditor were to review their data they would be pleasantly surprised at the clearly understood audit trail, links between documents and resources and samples, electronic signatures, and other clearly documented data.

 

YOUR ADVANTAGE
HOW WE DELIVER
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GXP (GMP, GCP, GLP) Compliance
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Audit Trail features audit records at the spreadsheet cell level for a comprehensive narrative of the initial documentation, subsequent updates, and review
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Conform to 21 CFR Part 11 Electronic Records & Signatures
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Review Alerts automatically highlight situations of potential concern.
Review Marks focus review on substance differentiating between initial and updated records.
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Process Control
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Electronic Signature provides acknowledgment of responsibility at key points of the documentation process