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Marathon 21CFR Part 11 Software - LE Version

  • Part #:MA0400-L
  • Availability:AVAILABLE
Price: $175.00
Price: $245.00

Description

This new Marathon 21 CFR-LE Software works with all electronic Marathon dataloggers and meets FDA requirements for electronic records and electronic signatures used in the pharmaceutical, biotech and medical industry. It is designed to comply with the Code of Federal Regulations Section 21 CFR Part 11 as required by the FDA.  Marathon 21 CFR DB validates data and works seamlessly with our Marathon Dataloggers. The software provides sophisticated data encryption and storage, administrative and multi-level user security profiles, as well as tools for manipulating and retrieving data. When used in conjunction with the Marathon dataloggers, the software provides a complete analytical solution for quality assurance standards.



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Features:

  • Section 21 CFR part 11 compliant for the FDA.
  • Password Protection (up to 10 alpha-numeric characters)
  • Multiple levels of security privileges. System access can be customized for each User.
  • Microsoft Access Database; industry standard format allows exporting to other databases. (Recommended Client/Server configuration with the database located on a secure server away from workstations)
  • Sort by dates, product codes, tracking numbers, shipper or any user defined attribute to electronically manage your data.
  • Electronic Signatures make paper records obsolete.
  • Encrypted Data means no risk of record alteration.
  • Electronic audit trails for regulatory compliance.
  • Compatible with all Marathon Dataloggers.
Specifications:
  • Licensed for 2 users plus Administrator
  • Recommended for users downloading less than 100 traces per year
  • View only 1 graph at a time
  • System Requirements: MS-Windows 98, NT, 2000 and XP. (We recommend that the database software be installed on a Windows 2000 or 2003 server by your IS or IT Department).
  • Controls for closed and open systems: Recorded files are encrypted to 128 bits or more in a RC4 variant. Recorded files are in binary, compressed and checksummed format proprietary to Marathon.
  • Complete and accurate electronic copies are available for reviewing the data, copying the raw data, exporting or by setting up "pdf printer" or order to print in a "pdf" format.
  • Secure individual accounts and passwords: Unique user names, login names and alpha-numeric passwords up to 10 characters. Users can never be deleted.
  • Audit Trails: Secure computer generated, time-stamped run-time audit trail of authorship, signatures, detailed configuration changes, imports and exports, administrator, activities etc.
  • Audit trails are embedded in the history file guaranteeing retention alongside the records and available for review/copying.
  • A separate Audit log monitoring individual logins, is kept outside of the Marathon 21 CFR DB program and can be deleted according to your standard operating procedures.
  • Signature Manifestations. Signed records contain printed name, date, time and meaning. Meaning includes Reviewed and Declined Review, Approved and Declined Approved, Record Created and Record Import
  • Signed authorization (authorship) and optional operator entered note. Name, time-stamp and meaning are all embedded in the binary format history file.

Additional Information

For use with ALL Marathon electronic Dataloggers.