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.
Usually it is a case of a contract expiring before weâve finished completing the services under the contract. We then draft an amendment, with an amendment effective date prior to the expiration date. The amendment references the agreement, provides for a new termination date, and then reaffirms the agreement.
It's stupid to issue a cure notice after a contract has expired. Issuing one against a contract that has not been awarded is incredibly stupid. Any CO who does something like that should be stripped of their warrant.