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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 ExcelSafe

    Try ExcelSafe with your MS Excel spreadsheets.

    Request a demonstration and a free 30-day trial

    These are frequently asked questions about ExcelSafe:

    Q: Is ExcelSafe difficult to implement?
    A: ExcelSafe is easy to implement:

    Q: Can I open multiple spreadsheets?
    A: ExcelSafe only allows one spreadsheet to be opened at any time. However, you can open multiple copies of ExcelSafe if you need to work in more than one regulated spreadsheet at a time.

    Q: What are the ExcelSafe system requirements?
    A: ExcelSafe requires MS Excel, version 2003 (or higher) and MS Access, version 2007 (or higher). The Enterprise version of ExcelSafe also requires SQL Server 2000 (or higher).

    Q: With which versions of MS Excel does ExcelSafe work?
    ExcelSafe works with all versions of Excel 2007 and up, including, Excel 2007, Excel 2010, Excel 2013, Excel 2016, and Excel 2019. ExcelSafe works with all MS Excel spreadsheet and template formats, including .xls, .xlsx, .xlsm, and .xlsb.

    Q: What were the results of the FDA’s use of ExcelSafe?
    A: The San Juan District Laboratory investigation showed that ExcelSafe improved analytical spreadsheet application data integrity, security, and template accountability by using electronic signatures, audit trails, and other compliance and tracking features. Using ExcelSafe improved laboratory efficiency by decreasing the time required for internal document review. They praised the ease of using ExcelSafe, noting that ExcelSafe had produced significant cost and time savings, and stated they would continue to use ExcelSafe. A copy of the FDA Laboratory Information Bulletin is available for download.

    Q: Which edition of ExcelSafe is right for me?
    A: ExcelSafe is available in three editions; ExcelSafe Enterprise, ExcelSafe Professional, and ExcelSafe Standard. All three versions of ExcelSafe provide immediate 21 CFR 11 compliance to spreadsheets. ExcelSafe Enterprise is intended for situations where an organization has more than 50 users, ExcelSafe Professional is intended when 5–50 users can share a common network location, and ExcelSafe Standard is designed to be run from a single computer, shared between a few users.

    Q: Does ExcelSafe run locally or from a shared drive?
    A: Both the Enterprise and Pro versions of ExcelSafe will run from a network folder. The Standard version requires that ExcelSafe be loaded on the local drive.

    Q: Is there anything added to the registry or desktop of the client computer?
    A: There is nothing about ExcelSafe 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 Excel properly installed.

    Q: Can ExcelSafe create new compliant spreadsheets from our existing templates?
    A: Yes. ExcelSafe can use your existing templates to create new compliant MS Excel spreadsheets. Templates can be added just as easily as any other spreadsheet and will be available for all users of ExcelSafe to create new workbooks with full compliance from the very beginning.

    Q: Our organization does not have any validation standards for Excel spreadsheets (we are a small biotech startup) but we need them! Can you help us?
    A: Yes. If you are starting a validation department, Ofni Systems can help you develop policies and procedures to validate spreadsheets.

    Q: Are there restrictions on the number of users?
    A: Information about number of users is located on the ExcelSafe Pricing Page.

    Q: How much does ExcelSafe cost?
    A: Pricing information is located on the ExcelSafe Pricing Page.

    Q: Can you validate our spreadsheets for us?
    A: Absolutely. Ofni Systems is a recognized industry leader in spreadsheet validation.

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