This document is intended to serve as a glossary of terminology applicable to software development and computerized systems in FDA regulated industries. It will facilitate consistency in describing the requirements of the law and regulations applicable to such products and systems. It is also a resource for investigators who conduct inspections and investigations involving software and computerized systems. The organization of this document is primarily alphabetical.
Re: Can we amend the expired contract? My opinion is that any contract has a specified life in itself. A procuring Entity can add life (by Extension) to a living contract before it is declared dead and buried(Expiry). Once a contract is dead (by way of expiry) it can not be returned back to life.
If an OFP has expired between the time of an alleged violation and the courtâs hearing on the violation, the court may grant a new OFP based solely on the respondentâs alleged violation of a prior order, which is effective until the hearing on the alleged violation of the prior order.