21CFR Software

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

• 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.

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.

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.