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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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    • Frequently Asked Questions about the Part 11 Toolkit

    These are some frequently asked questions about the Part 11 Toolkit.

    Q: How do I know the Part 11 Toolkit will work with my database?
    A: The Part 11 Toolkit has been available for 8 years and installed on hundreds of databases. We have never encountered an Access database where the Toolkit could not be successfully installed. We would be happy to give you a free demonstration, using your database.

    Q: How long does it take to install the Part 11 Toolkit.
    A: Most Toolkit installations can be performed in one business day.

    Q: We are still in the development process and our application changes continually. Can I continue to modify my application after the Toolkit is applied to it?
    A: Yes. The developer still has 100% control of the database, including the ability to make changes or add new functionality.

    Q: After validating the completed application, can I continue to add read-only objects such as reports?
    A: This is entirely dependent on the policies of your company. The addition of read-only objects, such as reports, will not affect data integrity, but the decision to allow changes of any sort to the application is between the developer and whoever has authority for approving such actions within your company.

    Q: Is there anything added to the registry or to the desktop of the client computer?
    A: There is nothing about the Toolkit that needs to be referenced on the client machine, either in the registry or placed on a local drive. The client computer will need to have MS Access properly installed, just as it would for running the application without a Toolkit applied to it. Depending on how your application is rolled out to the end users, it is not uncommon that the developer would wish to add a shortcut on the client computer, but this is not a requirement.

    Q: Can the toolkit be used with a MS SQL Server back-end?
    A: Yes, a version of the Toolkit is available for use with an MS SQL Server back-end data source.

    Q: Is the Part 11 Toolkit Office 2010, Windows 7, and Server 2008 x64 compatible?
    Yes, the Part 11 Toolkit is compatible with any environment that supports MS Access.

    Q: Can the Toolkit run on a network? Can the Toolkit run on a local drive?
    A: The Part 11 Toolkit can run on either a network location or a local drive.

    Q: Does the Part 11 Toolkit make my Access data completely compliant with 21 CFR 11?
    A: The Part 11 Toolkit does provide Access with all of the technological tools for an Access database to be compliant with 21 CFR 11, but there are additional procedural controls, including validation, training, and document control, which are also required.

    Q: Can you validate our Access database?
    A: Absolutely. Ofni Systems has several proprietary tools to analyze your Access database, and we use FastVal to facilitate the validation process. We can complete most Access database validations in a few weeks.

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