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Shipping & Validation Marathon Products Inc. Test & Measurement Packaing Container Seals Cryo-Shippers Rebates

 

 
021CFR Software

image of test tubes

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.


§ 11.10 Controls for closed systems
Comply
§ 11.30 Controls for open systems
Comply
§ 11.50 Signature manifestations
Comply
§ 11.70 Signature/record linking
Comply
§ 11.100 General requirements
Comply
§ 11.200 Electronic signature components and controls
Comply

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.

We offer three different 21CFR Compliant Software Packages:

21CFR-DB

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

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

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.

 MAIN SOFTWARE FEATURES
21CFR DB
21CFR LE
21CFR VIEWER
21 CFR- Part 11 compliant
Secure database
Electronic signatures
Levels of access permission, privileges, and authorizaiton
to customize what the users can do
Audit trails
User names, login names & passwords
Password minimum number of characters and
expire interval
Record search filter
 
 
Customized filter attributes
 
 
Record statistics & details
Record summary
 
 
Customized data entries & queries
Microsoft Access database
Real time display
 
 
Intelligent handling of time zones
Mean Kinetic Temperature
Import record
 
 
Export data to other 21CFR DB databases
Logger initialization
 
Read logger
Number of users
5 users plus administrator
2 users plus administrator
2 users plus administrator
Number of locations
1
1
1
Multiple tracing option
Up to 120 traces
in one graph
1 trace by graph only
1 trace by graph only
Validation Manual
One document containing the set of testing procedures and the template to perform the inhouse validation
Optional for additional fee
Optional for additional fee
21 CFR- Part 11 Compliance Report
A document reports how the 21CFR DB software addresses the 21 CFR part 11 Requirements
A document reports how
the 21CFR LE software addresses the 21 CFR part 11 Requirements
A document reports how the 21CFR LE software addresses the 21 CFR part 11 Requirements

Recommendations
  • Companies with one or multiple locations
  • Manage more than 100 records a year
  • Require more than 2 users
  • Require software validation documents in place for FDA inspections
  • Use programmable as well as single use units.
  • Companies with only one location
  • Manage less than 100 records a year
  • Require no more than 2 users
  • Write their own validation manual
  • Use programmable as well as single use units.
  • Locations that only receive units.
  • Read-only version.
    It cannot program loggers

Customer support & upgrades
2 years of customer
support, service packs and version upgrades (including enhancements). 90 day warranted satisfaction or full refund
1 year of customer support, service packs and version upgrades (including enhancements) 90 day warranted satisfaction or full refund
1 year of customer support, service packs and version upgrades (including enhancements) 90 day warranted satisfaction or full refund

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

pdf bug21CFR 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.

Get Adobe Reader

 
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rev. 21-Nov-2008