Ofni - Advisor Assesses Software

• 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

As the 21 CFR 11 FDA increases enforcement of 21 CFR 11, it is more important than ever that FDA-regulated businesses ensure that their systems are compliantwith all of the provisions of 21 CFR 11, Electronic Records Electronic Signatures.

The Part 11 Advisor is an efficient and effective tool for you to ensure that all of your computer systems are compliant with 21 CFR 11. Part 11 Advisor facilitates the creation of computer system inventories and guides you through the process of assessing the compliance status of each system. If you determine that any of your computer systems are not fully compliant, Part 11 Advisor helps you create Corrective Action Plans to address any compliance gaps, including suggesting remedies to meet shortcomings in compliance.

Click on each step to review features and view screen shots from the Part 11 Advisor.

• Introduction
• Evaluations and Review
• Long Term Tracking of Your Corrective Action Plan

Part 11 Advisor Benefits

• Be ready for any audit in weeks, not months!
• Build a well-trained workforce for evaluating new systems.
• Includes over 15 reports for scheduling and status updates
• Created by experts in Part 11 compliance who will support you throughout the assessment and remediation process

• Packed with Project Management Tools
• Program is automatically customized for each user
• Expect short-term gains of 10–25% simply by educating your workforce about Part 11 requirements.
•  – 21 CFR Part 11 compliant computer programs developed to your specifications