Cleaning Validation with FastVal
The FastVal software was created for the purpose of managing documentation for requirement-based testing. It is particularly suited to regularly-repeated testing, such as cleaning validations. From initial set-up through final review and sign-off, FastVal gives your cleaning program new capabilities for quality control and improved regulatory compliance.
FastVal provides a number of controls and checks to ensure that each cleaning validation is performed in full regulatory compliance and in accordance with your SOPs. In particular, it promotes standardized reporting language and efficient document construction and helps to ensure cleaning validation activities are thoroughly and accurately performed.
- Customization – Templates can be tailored to specific equipment, locations, or clients. FastVal lets you create any number of templates and keeps them organized, controlled, and manageable.
- Efficiency – Guided workflows and reduced repetition make for quick execution. FastVal users see up to 70% improvement in validation turn-around times.
- Security – Your electronic documents are fully compliant with 21 CFR Part 11, including complete audit trails, valid electronic signatures, and secure data.
- Versatility – FastVal works with your current reporting practices and Quality program. Documents can include any supporting documentation, such as analysis and microbiology reports, photographs, chromatography, deviations, and certificates of analysis.
- Documented Review – Quality Control review is integrated into the validation process. Detailed instructions guide reviewers to ensure every requirement is met and any deviations have been properly addressed.
- Project Management – Each cleaning validation begins with a validation plan. Here, the equipment to be cleaned, correct cleaning protocols, assigned roles, and scheduling due dates are entered. All responsibilities are defined, and the appropriate personnel are notified. FastVal provides project metrics and summary reports for continuous process improvement.
- Single Point of Control – Cleaning Validation Plans, Protocols, and Report documents are built using templates in FastVal. These templates are customized to your specifications and locked, ensuring the correct format and content of each report. Changes to templates can only be made by authorized users.
With FastVal, your cleaning program gains order, security, control, and speed. The sooner you sign-off on a successful cleaning validation, the sooner you can get started on the next production run. Bring a new level of confidence and quality to your cleaning program — contact us today for a FastVal demonstration or for any questions you have about Ofni Systems products or services.