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January 2, 2009 - FDA will discuss “Validation of Excel Spreadsheets in a Regulated Environment" and their experiences with ExcelSafe at Interphex ... More

December 17, 2008 - Ty Mew will present "Access & Part 11 Compliance" for ClinicalDevice.com on February 18, 2009 ... More

November 11, 2008 - Ofni Systems is recruiting MS Access Developers and Validation Specialists. ... More

 

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21 CFR Part 11 and Validation Resources

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Ofni Systems Tools and Services

Ofni Systems’ Electronic Data Management software reliably and efficiently automates complex record generation. FDA regulated industries, including pharmaceuticals, bioscience, medical devices and clinical trials, utilize Ofni Systems’ proven software and consulting to comply with 21 CFR Part 11, Electronics Records and Electronic Signatures, HIPAA (Health Insurance Portability and Accountability Act) and Annex 11, Computerized Systems.

Whether you are a CIO of a global corporation or heading a start-up, Ofni Systems can assess your compliance, validate your computer systems or assist your company with developing policies and procedures for electronic data control.

Ofni Systems Tools for Compliance

FastValTM
Produce validation documents, manage validation projects and execute testing protocols electronically in 70% less time.

ExcelSafeTM
Makes existing MS Excel spreadsheets compliant with all the technical requirements of 21 CFR Part 11.

Part 11 ToolkitTM
Transform MS Access programs into powerful, secure systems that meet all requirements of Part 11.

Part 11 AdvisorTM
Implement and manage every aspect of a Part 11 Remediation Plan.

MedWatch ReporterTM
Enter, store and print electronic copies of the FDA's Form 3500A form for serious adverse events.


Consulting and Services

Part 11 Assessments
Determine the compliance status of your computer systems.

Computer Validation
Validate new or updated software, database and computer systems.

Custom Programs
Develop a compliant computer system specific to your requirements.

Data Migration
Convert existing legacy data to an Access or SQL Server database.

Compliance Training
Learn to build a fully Part 11 compliant electronic record system.

Program Review
Application support, including adding features or troubleshooting existing issues.


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