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Thursday, May 15, 2014

ComplianceBuilder: Electronic Documentation for FDA


Instron understands that the Food and Drug Administration (FDA) requires biomedical testing results generated through software to comply with 21 CFR Part 11. Knowing this, Instron provides ComplianceBuilder as a solution to manage your electric records. Xybion, creator of ComplianceBuilder, discusses its features:

"If you are testing medical devices, pharmaceuticals, or any other product that requires the submission of data to the FDA and you are collecting that data electronically, you are required to adhere to FDA 21 CFR Part 11 Compliance. In short, Part 11 defines how any electronic documentation submitted to the FDA or required to be kept to comply with any FDA regulation shall be regulated and controlled. Failure to adhere to these regulations can result in hefty fines for your organization, and delays in delivering your products and services to the market.

ComplianceBuilder, a stand-alone, add-on package that runs with Instron’s Bluehill® Software, provides a data management solution designed to facilitate full compliance for your Instron systems. When test method or sample files are created, modified, or deleted, ComplianceBuilder stores the files in a secure data repository. The ComplianceBuilder file management system allows users to quickly and easily monitor all of these changes, which can be consolidated into an audit trail for FDA audits in just a few clicks. All file versions can easily be retrieved at any time from the database. Electronic signatures can be implemented to authorized personnel for device and authority checks, per the Part 11 requirements."

If you have questions on this subject, feel free to contact your local Instron representative to discuss further.

4 comments:

Anant Parghi said...

Hi there,
I am using Inston Compression test machine (3000 kN Capacity) the Univeristy of British Columia, Canada, for compression test of concrete cylinder of 100mm dia. and 200mm Ht. When I test the cylinder under compressive load with stain control mode (0.20 mm/min), I am getting the curve of Stain vs. Time in the reverse parabolic curve. But, theoretically it should be a ply inverted parabolic curve. I am just wondering that why, I am getting the reverse parabolic curve for compressive load in displacement control mode (0.20mm/min), however, the load control mode 0.25 MPa/Sec) it is inverted parabolic curve. Could you please explain me in details? Why this issue is arising? I would greatly appreciate you if you could reply me at the earliest. With regards,

Unknown said...

Hi Anant,

While this blog is in regards to ComplianceBuilder (achieving 21 CFR Part 11 compliance)we do have a feature in our software called Corrected Extension. Corrected Extension subtracts system compliance (stretching or compression in the nuts and bolts)from your crosshead extension. I am wondering if you are using this feature. I am happy to discuss further to learn about your method and test.

Best regards,
Elayne Schneebacher
Applications Engineer
Elayne_Schneebacher@instron.com

芭樂 said...

Hi,
Does ComplianceBuilder support data files generated by MiniTab or other 3rd party software?

Unknown said...

Hello,

ComplianceBuilder supports all relevant Instron files. In regards to our Bluehill 3 software, this includes method, sample, and data files.

If you are performing analysis in MiniTab or other 3rd party software Instron's ComplianceBuilder will not be able to track those changes.

However, if you are interested in tracking changes in 3rd party software please contact me via email and I can put you into contact with Xybion, the makers of ComplianceBuilder.

Best regards,
Elayne Schneebacher
Applications Engineer
Elayne_Schneebacher@instron.com