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.
ABC Company has held a D&O policy for the past 10 years, with an unlimited retroactive date. On renewal of the policy the company transfers their D&O coverage to a new insurer, which imposes a prior/pending litigation date of âpolicy inceptionâ, i.e. inception of the new policy. Prior to transferring insurer, a legal suit is filed to the courts by a former employee alleging wrongful dismissal.