21 CFR Part 11 Compliance.com

Excel Version Control

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  • Manage compliance and technological changes
    Excel version control system (EVCS) can help your company comply with current regulatory requirements and can grow as your business and software needs change, avoiding obsolescence, -- helping you to reach your compliance and business goals.

    - Security:      EVCS operates under multi-level security feature, ensuring
                          that only authorized and authorized users can access files -
                           - Network access security.
                           - EVCS application level security.
                           - SQL server database access level security.

    - Audit Trails:  There is an extensive audit trail maintained for all changes
                           made to the file -
                           User ID, Full user Name, Date/Time changes made,
                           Reason for changes made.

    - eSignature:    The electronic signature incorporates the user id and full
                           user name of signer, date/time signed.

    - Version Control:  A complete and controlled file versioning ensures a
                                 full revision history of any changes made to the file.
                                 Each version is date/time stamped. For company's
                                 that may engage in frequent changes and
                                 modifications to Excel spreadsheets, a special
                                 “Show Difference and Compare” feature in the
                                 EVCS lets users select any two Excel files
                                 (workbooks) for comparison. The "Show Difference
                                 and Compare" mode highlights the differences and
                                 changed or modified information in one Excel
                                 workbook file compared to another for easy visual
                                 inspection. 

  • Increase Productivity
    In organizations where technology has proliferated without controls, many different software platforms and versions of an application may exist, leading to uncontrolled versions of  data files and data integrity problems. Using EVCS to manage these applications can help address and stop these issues and thereby increase productivity.

  • Work more efficiently
    EVCS is completely transparent to end users, therefore users may continue working using the familiar Excel desktop environment without having to learn a new system and be fully compliant with all ISO 9000 and CFR Parts 11/58 requirements.
 

 

 

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