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Data Integrity is an Imperative, NOT an Option.

Reduce Organizational Risk,  Improve Compliance, and Ensure Data Integrity. Scroll down to learn more about Xybion’s ComplianceBuilder.

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Benefits

FDA defines data integrity as a key component of the CFR Part 11 Compliance to ensure every electronic record has completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). ComplianceBuilder™ enables meeting the ALCOA requirements as highlighted below:

Attributable

Enables functionality managing eSignatures, user sign-offs, email alerts.

Legible

Enables to generate readable and understandable records.

Contemporaneous

Tracks data real-time.

Original

Stores the file revision in a unique, secure data repository for ready retrieval of revision history.

Accurate

Ensures every electronic record has completeness, consistency, and accuracy of data.

Features

Full audit trails, electronic signatures and revision history enables organizations to reduce or minimize compliance risks for critical file-based systems, databases, and laboratory equipment.

Enables to promote compliance with internal business practices and operating procedures, critical for companies operating in controlled GxP environments through secured layer.

Allows to import data from Microsoft® excel spreadsheets, word documents, or any other file based system.

Offers management and control of any RDBMS-based system, SQL-based applications, batch systems and custom-developed DB applications.

Alerts the SharePoint® administrator when a user exceeds the thresholds.

ComplianceBuilder™ enables organizations to monitor and enable 21 CFR Part 11 compliance reducing enterprise regulatory risk.

Spreadsheet Validation for 21CFR Part 11 Rumors Risks and Realities

How to make SharePoint 21CFR part 11 Compliant