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.
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.
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.
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.