Method Validation in GxP Environments

Method validation is the documented process of ensuring a test method or assay is fit for its intended purpose. Regulatory guidelines dictate that analytical test methods used during drug discovery, development, and production will be validated and that validation activities will be summarized in a detailed summary report.

Creating a clear picture of your process and its scientific foundations conveys the quality of your work to clients and to regulatory reviewers. Proper documentation is more than summarizing data: it is what gives your analytical results credibility and drives product development, approval, and manufacture.

Ofni Systems assay validation products and services provide a scalable approach designed to help your business meet its regulatory needs. From initial discovery through pre-clinical development, clinical trials, and post-approval and production quality monitoring programs, we provide a means for quick, customized documentation that your method performs reliably and accurately.

Our validation specialists use FastVal to optimize the reporting process, incorporating standard language, approved templates, and built-in quality checks for robust method validation and study reports. FastVal puts you in control of your validation and study documentation and gives you the tools you need to meet regulatory requirements and satisfy individual client needs with speed and confidence. Every study requirement is tracked from start to finish. Your SOPs are integrated into your document and review workflows. Individual client needs are built into the project, ensuring each request is addressed. Quality Control and Quality Assurance reviews are documented in real-time, complete with audit trails, annotations, automated screenshots, and deviation tracking.


Ofni Systems method validation products and services provide the following benefits:

Instantaneous reporting and streamlined review
Promote your brand while adapting to client needs
Enforced application of house style
Standardized technical language
Automated formatting lets you focus on content
Part 11 compliant controls
Audit trails record all changes
Completeness checks ensure no missed requirements
Thorough linking and tracking of documentation, reviews, and sign-offs
Organizational control
Global template updates
User-level access control
Implement SOPs at the process level
Tracks projects, tasks, and milestones


Features and Capabilities

Our software is designed with the following features and capabilities:

Instant Report Generation
Custom Templates (Works with your existing templates)
Guided QC/QA Review with Audit Trails and Completeness Checks
Traceability from Validation Plan to Reporting to Review
Electronic Signing and Locking of Records
Project Status and Task Tracking
Change Control and Versioning
Real-Time Audit Trails
Paperless Option

Our approach gives auditors a clear picture of how your method integrates with your processes and controls, with no missing links. It’s not just a document; it’s documentation that your assay works reliably, that you have tested it thoroughly, and that you did things right. Ofni Systems believes there is a better way to document your method validations. Contact us today for more information or to request a demonstration.