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.
Evergreen or other contracts that renew automatically without any change in terms or other action by the parties and that exist by October 15, 2002, are eligible for the transition period. The automatic renewal of a contract itself does not terminate qualification for the transition period, or the transition period itself. Renewal or modification for the purposes of the transition provisions requires action by the parties involved.