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Products
Ofni Systems provides your FDA-regulated business with software and products to assist with 21 CFR 11, Annex 11, HIPAA, and other regulatory requirements for electronic data and signatures.
ExcelSafe
Part 11 Compliance For
MS Excel® Spreadsheets Simple To Use
Get spreadsheet control in a matter of hours Full Part 11 Compliance
Audit trails, electronic signatures and user security Spreadsheet Validation
We are FDA experts on spreadsheet validation Free Trial
Get a copy of Excelsafe to test today
FastVal
A Complete Validation Management Solution Create Documents
Fastval creates all your validation documents Electronic Execution
Execute validation protocols electronically Deviation Tracking
Deviation generation, tracking and management Project Management
Tools and reports to help manage people & projects
Ofni Clinical
eCRF Data Collection Database For Clinical Trials Case Report Forms
Converts your paper CRF's into eCRF's Edit Checks
Ensure data integrity with validation rules MedWatch Reporting
Automatically generates MedWatch FDA Form 3500A Rapid Implementation
Ready to use in days, not weeks or months
Part 11 Toolkit
Makes Any MS Access® Database Part 11 Compliant Audit Trails
Track all changes made in a database Electronic Signatures
Secure data with electronic signatures Database Validation
Let us validate your database for you Free Trial
Try the Part 11 Toolkit in your own database
Part 11 Advisor
Part 11 Auditing, Remediation and Training Tool Starting Gap Analysis
Facilitates the process of starting gap analysis Assessments
Collect and review data to identify Part 11 gaps Long-Term Tracking
Track the completion of your corrective action plan On-site Implementation
Hands on training on 21 CFR Part 11
Services
Ofni Systems provides your business with the highest quality consulting services to meet all of your compliance and quality needs.
Validation Services Software Validation
 Method Validation
 Process Validation
 Equipment Validation
21 CFR Part 11 Part 11 Training
 Part 11 Auditing
 Compliance Testing
 Software Assesments
Clinical Trials Custom Databases
 Database Testing
 Statistical Analysis
 Statistical Reporting
Other Services Data Migration
 SOP Writing
 Process Automation
 Mock Audits
Information
Ofni Systems is committed to assisting organizations with electronic records compliance, such as 21 CFR Part 11 and Annex 11. Let Ofni Systems make knowledge management simple for you.
21 CFR Part 11
A complete set of resources for 21 CFR Part 11 21 CFR 11.10(a)
Validation of computer systems 21 CFR 11.10(b)
Accurate Generation of Records 21 CFR 11.10(c)
Protection of Records 21 CFR 11.10(d)
Limited System Access 21 CFR 11.10(e)
Audit Trails 21 CFR 11.10(f)
Operational System Checks 21 CFR 11.10(g)
Authority Checks 21 CFR 11.10(h)
Input Checks 21 CFR 11.10(i)
Education, Training and Experience 21 CFR 11.10(j)
Policies for Electronic Signatures 21 CFR 11.10(k)
Document Control Part 11 FAQ
Validation of computer systems
Validation Resources
On selected validation documents Validation Planning
Define the scope and goals of a validation project. Requirement Gathering
Operations and activities that a system must be able to perform. Design Specification
Design Specifications describe how a system performs the requirements Installation Qualification
Verifies the proper installation and configuration of a System. Summary Report
Provides an overview of the entire validation project.
Other Resources
More information on FDA compliance FDA Warning Letters
Sample FDA 483 and Warning Letters Part 11 Publications
Useful 21 CFR 11 resources. Clinical Data Management
Best practices in handling data from clinical trials. Ofni Compliance Blog
Resources and information straight from the Ofni team.
About Ofni Systems
Ofni Systems is dedicated to helping companies address the requirements of 21 CFR Part 11, Electronic Records and Electronic Signatures.
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PDA


2013 PDA/FDA Joint Regulatory Conference

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Tyson Mew, president of Ofni Systems, will be at the 2013 PDA/FDA Joint Regulatory Conference in Washington DC on September 16-18, 2013. Ty will be demonstrating FastVal, Ofni Systems’ validation management system that provides validation managers with the unique ability to control their validation process. Using FastVal allows your validation engineers to do more testing while reducing the time required to complete a validation project by up to 70%. Ty will also be demonstrating ExcelSafe, which provides MS Excel spreadsheets with audit trails, individual user passwords and all of the technological controls required for compliance with 21 CFR 11 and other FDA regulations for electronic records and signatures.

The PDA/FDA Joint Regulatory Conference will provide FDA representatives and industry experts a forem to meet and discuss critical pharaceutical industry issues such as continual process validation, supplier management and quality oversite, supply chain and drug shortages and effective management of post inspection follow-ups. Parenteral Drug Association (PDA) is a global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community.

Ty Mew and Ofni Systems will be available throughout the conference to discuss validation management, spreadsheet compliance and accept resumes from validation professionals.

Registration information for the 2013 PDA/FDA Joint Regulatory Conference is available.


Ofni Systems to Exhibit at PDA FDA 2012 Conference: Redefining the C in CGMP Press Release

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Tyson Mew, president of Ofni Systems will be at the 2012 PDA FDA Joint Regulatory Conference in Baltimore, MD on September 10-12. The PDA FDA conference has the title “Compliance through Quality Systems: Implementing & Advancing a Sustainable Global Quality Culture”. In joint collaboration with the FDA, PDA has designed the conference to reflect how a robust quality system can enhance business goals and objectives. The conference will feature a series of regulatory and industry leaders in quality and compliance.

Registration information for PDA FDA Joint Regulatory conference is available.Ty Mew and Ofni Systems will be available throughout the conference to discuss software compliance, demonstrate their validation automation tools and accept resumes from validation professionals.

About Ofni Systems
Ofni Systems is an industry leader for 21 CFR Part 11/Annex 11 compliance and automating the validation process. Started in 1999, their products for compliant databases and spreadsheets are used by the FDA, pharmaceutical, biotech and medical device companies across the globe. They are the creators of ExcelSafe for Excel spreadsheet security and the Part 11 Toolkit for compliant databases. They also are the creators of the FastVal validation software for generating and executing validation documents, and have been providing professional validation services using FastVal since 2006. The company’s products for computer validation, auditing and FDA submissions ensure that their clients meet all requirements for electronic records and electronic signatures. Ofni Systems provides live desktop support for superior customer support and training. For more information, call (919) 844-2494 or visit www.OfniSystems.com.

Media Contact
Tyson Mew
President
Ofni Systems, Inc.
Phone: (919) 844 – 2494




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