ולידציה – URS and FRS Preparation Overview
This article was written by Iian Shaya, validation,automation and control expert
User Requirements Specification (URS) and Functional Requirements Specification (FRS) are the first and starting points of a validation process and a validation documentation file
– The validation process must comply with regulations issued by the United States Food and Drug Administration FDA
:The FDA regulations that are most relevant to the validation process are
Good Manufacturing Practice – GMP.
Current Good Manufacturing Practice – cGMP
Good Automated Manufacturing Practice – GAMP
The validation process includes design, installation and operation of a monitoring and control system for a production facility, as well as planning and execution of test procedures, to verify that a monitoring and control system meets the FDA standards
Validation documentation is part of the validation process that includes written and/or electronic records regarding the installation and operation of the monitoring and control system, and the corresponding test procedures for this system
Electronic records are often required to fulfill regulations set by the FDA. These regulations regard the scope and application of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11). Electronic Records may contain any combination of text, graphics, audio, pictures, or other information represented in electronic form, which are created, modified, maintained, archived, retrieved or distributed by a computer system
Electronic Signatures may contain computer data compilation of any symbol or series of symbols executed, adopted or authorized by an individual to be legally binding equivalent of the individual's handwritten signature
Electronic records and signatures are generally used in Closed Systems, in which the system access is controlled by personnel responsible for the contents of the system electronic records
The responsibility for writing and approving the URS and FRS is shared in practice by the user, who operates the production facility, and the supplier or vendor, who provides the monitoring and control system for ensuring the proper operation of the production facility. Usually, the URS is written by the user and the FRS by the supplier
:Note
The final contents of the URS and FRS are tailored according to the type and size of the system under validation. Since the URS and FRS regarded herein are generic, they include requirements that may not be necessary in small or simple systems
This article was written by Iian Shaya, validation,automation and control expert
