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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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  • (919) 844 2494

    • Validating MS Access Databases

    Microsoft Access and Compliance with 21 CFR 11 and Annex 11

    Leaders in 21 CFR 11 Compliance and Software Validation Projects, Assessments and Training

    Need Validation Help?


    Ofni Systems, a leader in MS Access validation, will quickly and efficiently validate all of your MS Access databases and ensure that your databases are compliant with all regulatory requirements.

    MS Access is an ideal information management tool for a small company or department. MS Access allows for relatively rapid development and quick implementation with little assistance from IT or other groups. Best of all, most employees already have MS Access installed and do not require additional software for developing their own data management solutions. The FDA and other regulatory bodies allow MS Access programs in GxP environments, as long as these systems are validated and have other technological controls in place to ensure that the database is compliant.

    Ofni Systems development team has written dozens of MS Access programs used in GMP, GCP, and GLP environments. (Unlike many development groups, we like MS Access.) Ofni Systems has the technical skill and compliance knowledge to ensure that your database meets all of the requirements of 21 CFR 11 and Annex 11.

    Experts in MS Access Validation

    As with any computer system, when MS Access is used in GxP environments system, data must be controlled and protected. This includes password protection to ensure only authorized people can access your data, audit trails to track changes to system data, and user-level security to ensure that system users only perform actions they are authorized to do.

    If your Access database does not already have the technological tools to be compliant with 21 CFR Part 11, Ofni Systems recommends the Part 11 Toolkit. The Part 11 Toolkit provides MS Access with audit trails, limited system access, password controls, and other technological tools for compliance.

    Our validation department has extensive experience validating MS Access databases. We know the potential pitfalls and security holes in Access and have the experience to address them. We have the tools to quickly analyze your MS Access database and generate validation documents that demonstrate that your system is compliant with 21 CFR and Annex 11. This allows us to spend our time efficiently, testing that your database actually performs the functions needed of it and not just generating paperwork.

    Benefits of Validating your MS Access Database

    Part 11 Toolkit provides the technological controls so MS Access is compliant with 21 CFR Part 11 & Annex 11

    Click here for more info

    Validating your Access program means all data can be used to make quality and GxP decisions or submitted to regulatory bodies like the FDA. You can query your data to better understand your business process. You gain confidence in your system and control over the data and who has access to it.

    Additional Resources

    Additional information is available on specific types of validation:

     

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