How to prepare User Requirement Specification
URS mean User Requirement Specification is a first document to define the procedure for the procurement of any equipment. Generally people make lot of mistake during preparation of user requirement specification and face a lot of challenge during equipment qualification so to avoid all these last minute surprise we have prepare a bullet proof URS to procure any equipment. Here is some guidance to prepare a bullet proof URS so refer all below points and consider during any URS preparation:
- The objective of the user requirement specification document should be very clear why we need this equipment and for which area and application.
System/ equipment details
Following details should be covered under this section
- The clear purpose of equipment/system/ instrument should be defined.
- Capacity/ output/ speed and other requirements from equipment should be defined
- Based on the final product requirement equipment requirement should be defined under this section.
Hygiene Design details
- Hygiene design requirement should be defined under this section as if equipment will be used in the manufacturing of products then following things to be considered
- The material of construction eg. SS 316
- Product contact surface finish e.g. free from pits, crevices, folds
- Sanitary type valve
- Zero dead leg valve
- Spray ball (in case of a vessel) coverage proven
- Data Integrity Assessment: To avoid any data integrity issue following feature should cover in URS
- ACCESS CONTROL: Provide the different levels of user access with password protection and limitation.
- DATA SECURITY & DATA CONTROL: Report should be in a non-editable format like pdf so that no one can alter the data
- TIME & DATE LOCK PROVISION
- SECURE DATA MIGRATION: Facility should be available for secure data migration.
- AUDIT TRAIL: Audit trail facility should be available with associated software like in HPLC, UPLC, GC,
- PRINTING FACILITY: Equipment/instrument should have a printer facility so that real-time data can be print, verify, and attached with a report. In case of a standalone instrument like weighing balance, pH meter where audit trail not available double roll paper can be used; one paper can be attached with a report and others can be preserved.
The equipment control system should be defined clearly as speed control provision, recipe preparation provision, fine-tune control, PLC/SCADA control, etc. Component/ Safety features/ Alarm & Interlock Details
All the critical components, safety feature, alarm and interlock details which can impact should be defined clearly in URS. Document requirements like; P&ID, Electrical drawings, GA drawings, DQ, IQ, OQ, PQ & Software validation package should be defined. Any other requirement should be defined Before procurement URS should be agreed by the equipment supplier also and if any deviation that shall be agreed in advance before procurement.