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21CFR Part 11 Compliant Software

Meeting the FDA’s requirements for electronic records and electronic signatures used in the pharmaceutical, medical and biotech industries, our database and Customer Relationship Management Software has been designed to comply with the Code of Federal Regulations Section 21CFR Part 11 as required by the Food and Drug Administration.

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21CFR Software
Download: 21CFR View

SKU: 8002 Category:

Description

21CFR Software for Regulatory Compliance—Marathon CRM Software

Meeting the FDA’s requirements for electronic records and electronic signatures used in the pharmaceutical and biotech industries, our database and Customer Relationship Management Software has been designed for the biotech, medical, and pharmaceutical industries to comply with the Code of Federal Regulations Section 21 CFR Part 11 as required by the Food and Drug Administration. Marathon 21 CFR DB validates data and works seamlessly with Marathon’s intelligent data collection devices. The software provides sophisticated data encryption and storage, administrative and multi-level user security profiles, and tools for manipulating and retrieving data. In conjunction with Marathon’s time and temperature data loggers, the software provides a complete analytical solution for quality assurance. Our industry focused approach benefits your operations even if your best practices do not require regulatory compliance.

CONTROLS FOR CLOSED AND OPEN SYSTEMS
  • Password protection (up to 10 alpha-numeric characters).
  • Unique user names and login names. Users can never be deleted.
  • Multiple levels of security privileges: system access can be customized for each user by the administrator.
  • Encrypted Data means no risk of record alteration. 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 Products, Inc.
  • Filter by dates, product codes, tracking numbers, shipper or any user-defined attribute to electronically manage your data.
  • Microsoft Access Database: industry-standard format allows exporting to other databases. Complete and accurate electronic copies are available for reviewing the data, copying the raw data, exporting or printing into PDF format.
ELECTRONIC AUDIT TRAILS FOR REGULATORY COMPLIANCE.
  • 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 the Marathon 21 CFR DB™ program and can be deleted according to your Standard Operating Procedures.
ELECTRONIC SIGNATURES MAKE PAPER RECORDS OBSOLETE.
  • Signed records contain printed name, date, time and meaning. Meaning includes Reviewed and Declined Review, Approved and Declined Approved, Record Created and Record Imported. Signed authorization (authorship) and optional operator entered note. Name, time-stamp and meaning are all embedded in the binary format history file.
SYSTEMS REQUIREMENTS

Microsoft Windows Operating Systems  XP, Vista, 7, 8 and 10 for client workstations. We recommend that the database software be installed on a Windows server by your IS or IT department.

We offer three different 21CFR Compliant Software Packages:

MAIN SOFTWARE FEATURES 21CFR DB #8002
Full Database
21CFR LE #8003
Limited Edition
21CFR VIEWER #8001
Read Only
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 statistics & details
Customized data entries & queries
Microsoft Access database
Intelligent handling of time zones
Mean Kinetic Temperature
Export data to other 21CFR DB databases
Read logger
Logger initialization
Import record
Record search filter
Customized filter attributes
Record summary
Real time display
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
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

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.

A sampling of 21CFR screenshots.

Record selection.
Logger plots.
Review & Approve
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