TABLE OF CONTENTS The user requirements specification (URS) is the key document in the whole of the system development life cycle that is required for both business (investment protection) and regulatory reasons (defining intended purpose). Spend sufficient time defining and writing testable requirements.
Both the GLP ( 58.61)14 and GMP ( 211.63)12 regulations require that equipment be fit for intended purpose; therefore, to define intended purpose a URS is required.
Annex 11, Clause 227 states:
The extent of validation necessary will depend on a number of factors including the use to which the system is to be put, whether the validation is to be prospective or retrospective and whether or not novel elements are incorporated. Validation should be considered as part of the complete life cycle of a computer system. This cycle includes the stages of planning, specification, programming, testing, commissioning, documentation, operation, monitoring and modifying.
This withdrawn FDA draft guidance23 discusses the main points in the life cycle of a computerised system and makes the point that a system requirements specification (SRS) is required. In the FDA s view:
Without first establishing end user needs and intended uses, we believe it is virtually impossible to confirm that the system can consistently meet them.
Put in its bluntest form: without a requirements specification you cannot validate your CDS.
Once you have established the end user s needs and intended uses, you should obtain...
