Compliance Solutions for FDA 21 CFR Part 11

Ofni Systems provides industry-leading software and services to companies who must be compliant with FDA 21 CFR Part 11, Electronic Records; Electronic Signatures. The goal of Part 11 is to protect the electronic data within your systems; our software and services will ensure your company is compliant with all aspects of 21 CFR Part 11. We also offer a full range of training courses on all aspects of FDA regulations, requirements, guidance documents, and validation practices.

FDA 21 CFR Part 11 Information

• Introduction to 21 CFR Part 11 – An introduction to 21 CFR Part 11, describing the requirements associated with the regulation
• Validation Documents – Information about validation and the documentation expected in a validation package
• 21 CFR Part 11 Resources – FDA guidances, case studies, sample code, and other resources regarding 21 CFR Part 11 and Validation
• Warning Letters – A collection of warning letters issued by the FDA about compliance issues

FDA Part 11 Compliance Consulting and Services

• 21 CFR Part 11 Training – Train your employees on Validation and 21 CFR Part 11 regulations and guidances
• 21 CFR Part 11 Assessments – Ensure your computer systems are compliant with 21 CFR Part 11
• Compliance Auditing Services – Audit preparation, checklists, audits, and audit responses
• Data Migration – Move data safely, securely, and compliantly
• Clinical Data Management – Ensure your clinical trials meet requirements of Part 11 and HIPAA

Software Solutions for CFR 21 Part 11

• ExcelSafe – 21 CFR Part 11 Compliance for MS Excel
• Part 11 Toolkit – 21 CFR Part 11 Compliance for MS Access
• Part 11 Advisor – Assess your systems and develop compliance plans
• Ofni Clinical – 21 CFR Part 11/HIPAA compliant databases for your clinical trial
• Custom Programing – 21 CFR Part 11 compliant computer programs developed to your specifications

21 CFR Validation Tools and Services

• FastVal Document Generator – Facilitate and manage all of your validation projects
• Computer System Validation – Be compliant with FDA and 21 CFR Part 11 validation requirements
• Validation for Proprietary Software and Databases, such as SAP, LIMS, or Trackwise
• Validation for Web Applications and Pages
• Validation for MS Access Databases and MS Excel Spreadsheets
• Software Testing – Expert Quality Assurance testing for GMP, GLP, and GCP environments.
• Method validation services
• Process and Equipment validation services
• Cleaning validation services