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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
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| § 11.30 Controls for open systems |
Comply
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| § 11.50 Signature manifestations |
Comply
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| § 11.70 Signature/record linking |
Comply
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| § 11.100 General requirements |
Comply
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| § 11.200 Electronic signature components and controls |
Comply
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We offer three different 21CFR Compliant Software Packages:
21CFR-DB
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Licensed for 5 Users + 1 Administrator
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Recommended for users downloading >100 traces per year>
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Advanced Filter and Custom Filter capabilities, i.e., search
by Serial Number, Tracking Number, Start Date, etc.
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View up to 250 graphs at one time
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Secure Database Program with Electronic Signatures
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Software Validation Manual
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Software Compliance Report
21CFR-LE
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Licensed for 2 Users + 1 Administrator
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Recommended for users downloading <100 traces per year
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View only 1 graph at one time
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Secure Database Program with Electronic Signatures
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Software Compliance Report
21CFR-Viewer
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Licensed for 2 Users + 1 Administrator
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Read Only Software - Can not be used for programming temperature
loggers
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Recommended for Satellite Offices or Clinical Trial Sites
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Secure Database Program with Electronic Signatures
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Software Compliance Report
All three software packages can be used with our temperature data loggers
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Validated and Validatable
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Certificate of Compliance
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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.

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