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.
The following require retroactive treatment: 1. Change from LIFO to any other inventory method. 2. Change to or from full-cost method of accounting by entities in the extractive industries. 3. Change to or from the completed contract method for long-term construction contracts. 4. Change from retirement-replacement-betterment accounting to depreciation accounting for railroad track structures. 5.