A Scalable Approach to Method Validation

Per current regulations, every test validation, every sample analysis, and every investigation culminates with a detailed summary report. This requirement ensures each drug intended for human use generates a massive amount of documentation. Method development, qualification, validation, stability, and transfer reports establish a test method, which is then used in generating the numerous study reports that support a drug development program. The sheer volume of documentation required for each product leads to reporting bottlenecks and results in production delays that affect all phases of drug development.

Eliminating the Reporting Bottleneck

Ofni Systems software provides efficient reporting tools that remove documentation bottlenecks. In addition to automating report production, data processing, and the review cycle, our software provides added security features, quality controls, and 21 CFR Part 11 compliance. These tools allow for effective management of time and resources to help you achieve production targets.

One Goal, Two Approaches

Ofni Systems understands that method validation needs vary from business to business. Some laboratories only run a few methods; some have tens or hundreds. Some perform one or two assay validations a year; some perform several per week. Validation frequency is the driving force for deciding to contract validation services or to manage them in-house. Ofni Systems understands both approaches and provides services and software designed to accommodate either.

Method Validation Services

Companies with infrequent validation needs will find it practical to contract our services. We offer high quality, quick turn-around using robust tools and an up-to-date knowledge of current regulatory trends and industry practices. Our services allow clients to keep their staff focused on revenue-generating activities while fulfilling regulatory requirements in a well-documented, secure fashion.

Method Validation Products

Companies with more complex validation needs find greater value in bringing Ofni Systems software products in-house. Using FastVal with your method validations provides an efficient framework for conducting and documenting validation activities, producing custom documents, audit trails, and review records quickly and reliably. In addition, FastVal can produce sample analysis reports that are linked to the parent validation, ensuring consistency throughout related reports.

Of course, FastVal also allows you to validate your analytical spreadsheets. Used in conjunction with ExcelSafe, your validated spreadsheets become secure, reliable data tools with full 21 CFR Part 11 compliance. With validated data processing, your QC and QA review burden is significantly reduced, and your results are readily formatted for drop-in reporting.

Solutions to Scale

Whether your lab specializes in running one test method or you develop ten assays a week, good documentation is a major component of your business. It is a regulatory requirement for both you and your clients. And it takes time. At Ofni Systems, we believe in eliminating the reporting bottleneck while maintaining compliance and ensuring client satisfaction. We provide solutions to fit your operational scale. Contact us today to learn how our software and services can benefit you.