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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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  • (919) 844 2494

    • Data Integrity Solutions

    As FDA auditors increase their focus on data integrity issues, it is becoming more difficult for companies to ensure that their data and record management practices are compliant. Data integrity goes beyond the use of compliant and validated systems and requires the implementation of multiple procedures/controls throughout the data life cycle. Ofni Systems has experts in current good data and record management practices who can offer the tools and training employees need to maintain data compliance.

    Data Integrity Training and Consulting

    In recent years data integrity compromises have become an international epidemic in GxP facilities. Ofni Systems can help your company pass its FDA audits through our training programs and consulting services. We have tools and training services that can be tailored to your company’s unique needs, whether your facility is GMP, GLP, or GCP.

    Through attending data integrity training, your employees will learn how to reduce costly mistakes and recalls by gaining knowledge and understanding of best practices from the most recent data integrity guidance documents. Training participants will learn how to facilitate a no blame culture through encouraging a positive attitude toward finding, fixing, and preventing mistakes.  As part of Ofni’s training program you will receive instructional and training materials based around either an individual or group learning environment. Ofni Systems provides training certificates for all employees that attend our training.

    Data Integrity Auditing Services

    New data integrity guidance calls for enforcing stricter policies for documentation review. The new FDA data integrity draft guidance proposes that the review of audit trails be mandatory and suggests several steps to complete the review. The process that the FDA recommends consists of determining the scope of the problem, implementing a corrective action plan, and removing at all levels individuals responsible for problems from cGxP positions. The FDA also encourages hiring a third party auditor to serve as an unbiased reviewer. Ofni Systems can serve as a third party auditor to help prepare you for your FDA audits.

    Policy and Procedure Review

    Our company will review your current policies and procedures for best data integrity practices. We will help you ensure that you are in compliance with major data integrity guidance documents. With our combined experience in Part 11 auditing, data integrity auditing, and producing validation packages for computerized systems we will help optimize your workflow integrity.

    Audit Trail Review

    Ofni Systems’ auditors have the experience and tools to analyze your audit trails using our audit trail summary report. We can review your audit trails and implement procedures for your company to more easily review audit trails on an ongoing basis. Our tools will make audit trail review a breeze while identifying more data integrity issues.

    Data Migration

    Ofni Systems has the experience to perform all phases of the data migration process. We can enable your company to move data safely, securely, and compliantly in order to maintain the integrity of you data throughout its lifecycle.

    Tools/Software for Managing Data Integrity

    Additional Information

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