Method Validation with FastVal

The FastVal software was created for the purpose of managing the documentation of requirement-based testing. It is designed to automate the production of auditable, secure documents with maximum efficiency and versatility. FastVal ensures reports are consistent and complete and provides for integrated Quality Control review and project tracking.

Ease of Design

The first step of reporting is developing good templates. FastVal provides for modular template assembly: required validation activities and associated text are added from a custom pool of approved content. This allows you to create consistent validation templates for any type of method and for any client. Add comments, notes, and instructions, so that reporting staff have a clear understanding of how each template should be used. After final approval, the template is locked and ready to begin generating reports.

Ease of Execution

New method validation projects follow your approved templates. The report is automatically populated with project-specific information, data tables and supporting documents and graphics are attached, and any additional analytical notes or discussion can be included. The first draft is printed and ready for review.

Ease of Review

FastVal facilitates Quality Control review of method validation materials by guiding reviewers through each step of the process. Reviewers sign each step electronically, attach any supporting information or examples, and the entire process is tracked for auditing and metrics. FastVal ensures complete and documented QC review, adding value to your method validation and reporting process.

Ease of Audit

FastVal links and tracks requirements. Every element of the Validation Plan or Protocol has a corresponding section in the Validation Report and in the QC Review sign-off. Auditors can quickly confirm the satisfaction of each validation requirement and trace it through the process.

Additional Reports, Amendments, and Revisions

Additional reporting, such as long-term stability or partial validation reports, are just as easy to produce. FastVal maintains the structure and links from the original validation, with subsequent reports built on the established base. This reduces repeat work and promotes consistency among final products.

FastVal Documents

FastVal is capable of generating a variety of documents, from polished final reports to internal metrics and review records. Example FastVal documents include:

Validation Plans
Validation Protocols
Validation Summary Reports
Stability Reports
Sample Analysis Reports
Amendments and Revisions

QC/QA Review Records
QC/QA Review Summaries
Deviations and Summaries
Test Methods
Requirement Tracking
Audit Trails

FastVal does it for you.

FastVal automates report production while ensuring regulatory and SOP compliance. It provides fine control over product and process, with a centralized workspace, full audit trails, and enhanced security. With FastVal, your validation program gains order, security, control, and speed. The sooner you sign off on a successful method validation, the sooner you can get started on sample analysis. Bring a new level of confidence and quality to your validation program — contact us today for a FastVal demonstration or for any questions you have about Ofni Systems products or services.