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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
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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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FastVal
Validation Project Metrics
Risk Assessment
FastVal Details
FastVal Design Specification Template
FastVal Installation Qualification Template
FastVal Operational Qualification Template
FastVal Performance Qualification Template
FastVal Summary Report Template
FastVal Traceability Matrix Template
FastVal Deviation Report Template
Automatic Summary Report
Document Generation
Gathering System Requirements
FastVal Traceability Matrix
Validation Project Management
Protocol Execution
Deviation Tracking
FastVal Change Control
Deviation Resolution
FastVal Validation Summary Report Template
FastVal Validation Plan Template
FastVal User Requirements Template
FastVal Functional Requirements Template
Validation Methodology
FastVal – Live Demonstration
FastVal – Summary of Key Benefits
FastVal Frequently Asked Questions
FastVal Info PDF
Project Management Tools
ExcelSafe
ExcelSafe Details
ExcelSafe Audit Trail Report
Main Menu
Electronic Signatures
Search Engine
Password Security
User Administration
ExcelSafe Audit Trails
Data Management
ExcelSafe Enterprise
ExcelSafe Professional
ExcelSafe Standard
Pricing
Benefits of ExcelSafe
Frequently Asked Questions about ExcelSafe
Excel Spreadsheets
Ofni Clinical
Edit Checks in Ofni Clinical
Electronic Case Report Forms for Clinical Trials
Ofni Clinical Features
Ofni Clinical Implementation
Ofni Clinical – Frequently Asked Questions
Ofni Clinical – Summary of Key Benefits
Ofni Clinical Services
Ofni Clinical – Services and Support
Part 11 Toolkit
Details
Password Security
User Administration
Audit Trails
Part 11 Toolkit – Electronic Signatures
Search Engine
Advanced Features
Benefits
Implementation
Ensuring Compliance
Frequently Asked Questions
How to buy
Free Trial Offer
Summary
Part 11 Advisor
Part 11 Advisor – System Evaluation Detailed Report
Starting Gap Analysis
Main Menu
Sample Part 11 Advisor Summary Reports
Assessments
Gap Analysis
Corrective Actions Wizard
Managing Corrective Actions
Summary Report
Systems to Evaluate – Part 11 Advisor
Corrective Actions Report
Part 11 Advisor – Steps for Implementing a Part 11 Remediation Plan
MedWatch Reporter
MedWatch Reporter Features
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Services
SOP Writing
Method Validation in GxP Environments
Method Validation with FastVal
Bioanalytical Method Validation
Analytical Method Validation
Frequently Asked Questions about Method Validation
Validation Services
Requirements Traceability Matrix (Trace Matrix, RTM, TM)
Process and Equipment
Spreadsheet Validation
Validation – Summary of Key Benefits
Validation Summary Report (Validation Report, Summary Report, VR, SR)
Validation Documents and Projects
Problems Using MS Excel Track Changes as an Audit Trail
Software Validation
Validation Terminology
Change Control for Validated Systems
User Requirements Specification (User Specs, URS)
Functional Requirements (Functional Requirement Specifications, Functional Specs, FRS, FS)
Cleaning Validation
Cleaning Validation with FastVal
Design Specifications (DS)
Test Plan / Test Protocols
Installation Qualification (IQ)
Operational Qualification (OQ)
Spreadsheet Validation Package
Performance Qualification (PQ)
Test Protocol Deviations and Deviations Management
Validation FAQ (Frequently Asked Questions about Validation)
Validation Master Plans (VMP)
Validation Plans (VP)
Validating MS Excel Spreadsheets
17th
Validating Mi-Co Mi-Forms e-forms
MS Access Validation
Validating Web Applications and Web Pages
Risk Assessment (RA)
Clinical Data Management
Process Validation and Equipment Validation
Custom Programs
Software Testing
Data Migration
GxP Auditing Services
Part 11 Assessments and Compliance Assessments
Compliance Training on 21 CFR Part 11
Data Integrity Solutions
A Scalable Approach to Method Validation
Example Validation of an Excel Spreadsheet
Information
FDA Insights
21 CFR 11 Resources
Introduction to Clinical Data Management
Introduction to 21 CFR Part 11
21 CFR 11.10(a) Validation of Systems
21 CFR 11.10(g): Authority Checks
FDA Increasing Emphasis on 21 CFR 11
Sample Letters of Non-Repudiation Agreement
Customer Support
Assay Validation Guidelines
Contact Information
Header Revision
Get ExcelSafe
Serious Adverse Event Reporting and FDA MedWatch Form 3500A
GCP, GLP, and GMP Validation Automation With FastVal
FDA 21 CFR Part 11 Information, Consultation and Tools for Compliance
Sample Warning Letter
Clients
Employment Opportunities
Cleaning Validation Engineer 1
Software Developer (Internal Tools)
Computer System Validation Engineer 2
Computer System Validation Engineer (SAP) 1
Process Validation Engineer 1
Alliances
FastVal Benefits Tour
Disambiguation of Clinical Database Validation and Clinical Data Validation
Document Validation
About
Computer Systems Validations Manager
Clinical Database Validation
Clinical Data Validation
Additional Downloads
21 CFR 11.10(b): Accurate Generation of Records
21 CFR 11.10(c): Protection of Records
Getting Started with ExcelSafe
FastVal Preview PDF
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(h): Input Checks
21 CFR 11.10(i): Education, Training and Experience
21 CFR 11.10(j): Policies for Using Electronic Signatures
Compliance Software & Services Sales Specialist
21 CFR 11.10(k): Document Control
Computer Systems Validation Engineer
Thank You
Annex 11 (1) Risk Management
Annex 11 (2) Personnel
Privacy Statement
Case Study: Dana-Farber Cancer Institute
Annex 11 (3) Suppliers and Service Providers
Case Study: Mi-Co
Terms of Use
Sample Code for the Audit Trail Function
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