Secure Software for OM-CP Dataloggers with FDA 21 CRF SupportSecure Software for Use with OM-CP Series Data Loggers
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- Install, Validate and Operate One Software Program Universally
- Compatible with Most OM-CP Series Data Loggers
- Time and Cost Saving Validation Package–Stands up to Interrogation from Auditors
- Automatic Data Security and Audit Trail
- Sophisticated User Maintenance
- Traceability with Customizable Electronic Signatures and Audit Trails
- Aids in Compliance with FDA 21 CFR Part 11/820 and GxP Guidelines
- Applications: Pharmaceutical, Medical, Hospitals, FDA Regulated Organizations, Temperature Mapping
OM-CP-SVP-SYSTEM Model OptionsView all models
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DescriptionThe OM-CP-SVP-SYSTEMSecure Software aids customers incompliance with 21 CFR Part11 requirements. The softwareensures standards in which electronicfiles are considered equivalent topaper records, saving time andeffort.
OM-CP-SVP-SYSTEMSecure Software contains criteriasuch as electronic signatures,access codes, secure data files,and an audit trail which meet therequirements of 21 CFR Part 11 andhelp provide data integrity. IQ/OQ/PQ(Installation Qualification/OperationalQualification/PerformanceQualification) protocols are includedwith the purchase of theOM-CP-SVP-SYSTEM SecureSoftware to validate that the softwarehas been installed and is operatingcorrectly. The layout of the securesoftware is similar to the OM-CPSeries Data Logger StandardSoftware, allowing users to easilylearn the additional features.
The Windows® based softwarepackage allows the user toeffortlessly collect, display andanalyze data. A variety of powerfultools provide the ability to examine,export, and print professional lookingdata with just a click of the mouse.
Logger Auto-Detection—Saves Time, Secures Data
The software automatically detectsloggers as soon as they are pluggedinto the computer. With minimaluser involvement, drivers are theninstalled, data is downloaded, anda graph of the data is rendered onscreen.
Linked Data—Saves Time and Effort
Graphs and data grids can now belinked, allowing the user to quicklyand easily modify multiple views ofthe same information. Make a changeto the data grid and the informationon the linked graph synchronizesimmediately and automatically!
Multiple Data Sets—Makes Mapping a Breeze
Mapping data has never been soeasy—or fast! Now data from multipleloggers can be easily combined in asingle data grid by simply draggingand dropping data sets, creating aside by side comparison of data foreach logger.
Software Overview—Security Settings
On the following pages are anoverview of the important 21 CFRPart 11 compliance features in theOM-CP-SVP-SYSTEM SecureSoftware. Each feature is important insecuring data and ensuring tampereddata is recognized by theOM-CP-SVP-SYSTEM SecureSoftware.
Administratorand User Settings
Users can be given two levels ofaccess, either administrator or user.Administrators have access to all thesecurity settings, while users onlyhave access to communicate with thedata loggers and analyze data.
Users and Administrators can beassigned to Groups and can beeasily maintained using a varietyof permissions.
Login attempts and lockoutduration can be assigned withinthe Login tab. There are numerouspassword and account settingsfor the administrator to set suchas the complexity of the passwordand status of each user account.The user management tab is onlyavailable to administrative users.
An Audit Trail is kept automaticallywith information such as who haslogged in and out, what files weredownloaded, saved, printed etc. Eachrecord is date and time stamped andincludes the user information.
By clicking the Electronic Signature button, usersand administrators can add electronic signaturesThe electronic signature contains the printedname of the signer, date and time of the signingand the meaning of the signing.