These are the most frequently asked questions about the FastVal Validation Document Generator.
Q: Do you offer validation services?
A: Yes! We offer a full range of validation services, including document generation and protocol execution. We will work with you to determine the level of validation needed and the structure/format of documents required to make sure that we match your existing corporate standards.
Q: We have rigid requirements for the content, structure, and format of our documents. Can your program meet these requirements?
A: Yes, the content required by your corporate templates can be entered, and the resulting output can be formatted to match your existing document formats.
Q: Can FastVal integrate into our existing validation process and other Quality systems, like our CAPA system?
A: Absolutely! FastVal is designed to integrate into your existing validation process and integrate into existing quality systems.
Q: How does FastVal use our existing company templates?
A: Part of FastVal configuration is to incorporate your existing company templates into the system. Specific document template types are entered, as well as your logos and style requirements. This means that documents exported from FastVal will have the same look and feel as your current documents.
Q: Our organization requires validation plans, user requirements specifications, vendor assessments, unit tests, user acceptance testing, factory acceptance testing, site acceptance testing, etc. Can these and other documents also be generated by the program?
A: Yes, any related documents that are required can be added to the program document templates.
Q: How does FastVal reduce validation time by 70%?
A: FastVal has a number of tools to facilitate document writing and validation projects. (More about our validation methodology.)
Q: Can FastVal be used to generating documents to qualify facilities and production equipment as well as CSV?
A: Of course! FastVal can be used to generate documents for any requirements-based testing. In addition, it can be used to create many other document types, from SOPs to memos to whatever other type of document is required. The resulting test cases (UAT, IQ, OQ, PQ, etc.) can also be electronically executed.
Q: Our organization does not have any validation standards (we are a small biotech startup) but we need them! Can we use your existing templates as a basis to help define our new requirements?
A: Yes, that is one of the reasons we included them in the program. Our templates may be used out of the box, or you can edit them to meet your individual needs.
Q: Can documents produced from FastVal only be used in FastVal?
A: FastVal produces MS Word and PDF documents; once created, these documents are maintained by your document management system like any other MS Word or PDF document.
Q: Our organization does not allow electronic execution of protocols. Is this a requirement for use of the program?
A: No. Protocols can be printed to allow for manual execution, if required.
Q: When you electronically execute protocols, how do you handle screen shots?
A: The software has the capability to capture screen shots in both GIF and JPG formats. These images appear under each step of the printed protocol.
Q: Is FastVal fully compliant with 21 CFR Part 11, Electronic Records and Signatures?
A: Yes, FastVal is fully compliant with 21 CFR 11, including audit trails and the ability to apply multiple electronic signatures for any document.
Q: Can Ofni Systems help us standardize our validation practices?
Yes. Ofni Systems can provide any level of support to your validation department. If you are starting a validation department, Ofni Systems can help you develop validation templates, policies, and procedures. If you have existing validation department, Ofni Systems can review your policies and suggest improvements.
Q: I’d like to see the software. How can I arrange a live demonstration?
A: We would be happy to arrange a live WebEx meeting for you at any time, please contact us to make arrangements.