Valid Systems support for Regulatory Compliance

Food and Drug Administration

Companies operating under the regulatory requirements of the FDA realize the requirements under 21CFR part 11 are comprehensive and demand sound understanding and careful consideration.  The Valid Components  provide the necessary building blocks for a validated, compliant system.

Valid Systems has developed industry specific solutions. 

 

The ValidSolution for Medical Device Testing Laboratories

Using the ValidLibrary, a electronic document management system, and the ValidRepository, a FDA compliant recordkeeping system, Valid provides a complete solution for Medical Device Testing Laboratories.  The solution delivers a document, record, and data management solution proven to satisfy FDA regulatory requirements and streamline the test results reporting, stripping valuable days or weeks off the process.

 

The ValidSolution for Submissions

Using the ValidLibrary, a electronic document management system, and the ValidRepository, a FDA compliant recordkeeping system, Valid provides a complete solution for building electronic submissions for the medical device industry.  The solution delivers a document, record, and data management solution proven to satisfy FDA regulatory requirements and streamline the submission assembly and review process.

 

 

Securities and Exchange Commission

Under Federal and many state rulings, corporate e-mail is recognized as a discoverable form of electronic information and must be managed and produced on demand (SEC 17a-3).  The Valid eMail Manager solutions will make your email system compliant with the requirements of SEC 17a-3.  Recent history has demonstrated that the first place a litigator will go to learn about your company is your users email files! 

The Valid eMail Manager for Microsoft Exchange and the  Valid eMail Manager for Lotus Notes provide a complete solution for managing and archiving the e-mail used in your business and meeting regulatory compliance.