Method validation is the process of establishing documented evidence that a method is suitable for its intended use. It is an important regulatory requirement for pharmaceutical and other regulated industries, as it provides documented evidence and assurance that the methods in use are suitable for the determination of identity, quality, strength, purity, and potency of drug products.
The method validation process can be a time-consuming and repetitive task, consisting of several sequential steps. These steps include, sample preparation and experiment setup, validation (protocol generation, review and approval), data acquisition, calculation of results, and report generation. Of these, one of the most time-consuming and tedious process is validation. Currently, this process is typically handled through a manual process on paper.
Features and Benefits
- A workflow based system, manages the entire validation process along with other required data and documents.
- Configurable and adaptable to a specific corporate environment.
- Create and reuse validation protocols within the software.
- Ability to specify acceptance criteria depending on development stage, assay type and compound type.
- Ability to assign pre-configured run sequence templates to a validation protocol.
- Ability to specify multiple tests for a single injection.
- Fully controlled and compliant with regulatory requirements.
- Provides real-time validation status through KPI dashboard.
- Flexible, built in reporting tool.