Marathon is pleased to announce a software solution to the 21 CFR Part 11 Code of the Federal Regulations, as promulgated by the FDA.

Section 21 CFR part 11 establishes the criteria under which the FDA will accept electronic records and electronic signatures as equivalent to paper records and handwritten signatures. To comply all FDA required records under Section 21 CFR Part 11 must be generated by a reliable software that assures the following: record integrity during the retention period, retrievable for FDA inspection, audit trails, limited system access, and use of electronic signatures, as defined by prior guidance.

We offer three different 21CFR Compliant Software Packages:

21CFR-DB

• Licensed for 5 Users + 1 Administrator
• Recommended for users downloading >100 traces per year>
• Advanced Filter and Custom Filter capabilities, i.e., search by Serial Number, Tracking Number, Start Date, etc.
• View up to 250 graphs at one time
• Secure Database Program with Electronic Signatures
• Software Validation Manual
• Software Compliance Report

21CFR-LE

• Licensed for 2 Users + 1 Administrator
• Recommended for users downloading <100 traces per year
• View only 1 graph at one time
• Secure Database Program with Electronic Signatures
• Software Compliance Report

21CFR-Viewer

• Licensed for 2 Users + 1 Administrator
• Read Only Software - Can not be used for programming temperature loggers
• Recommended for Satellite Offices or Clinical Trial Sites
• Secure Database Program with Electronic Signatures
• Software Compliance Report

All three software packages can be used with our temperature data loggers

• Validated and Validatable
• Certificate of Compliance
• NIST Calibration Reports

We recommend this software to all pharmaceutical and biotech companies especially those conducting Clinical Trials.

For more information, download the 21CFR Data Sheet in PDF format.

21CFR DATA SHEET

For more information please contact us for a live demonstration over the Internet.

Hardware Recommendations: Although the program will run on Microsoft Windows XP or 2000, we recommend that it be installed on a Microsoft Windows 2000 or 2003 Server by your IT or IS department for maximum security.

Unlike our competition, this is not a web based program. You do not have to conduct an extensive QA Audit to find out if the program is truly 21 CFR Part 11 compliant.

To open the 21CFR Data Sheet, you will need Acrobat Reader 4.0 or higher. Click the icon below to download the newest reader software.