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.
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.