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.
3.01 The MSECP does not apply to any individual who terminated employment with the employer prior to the effective date of this amended and restated MSECP (January 1, 2009) unless such individual becomes reemployed by the employer on or after such effective date.