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    24 views10 pages

    URS Sample

    Uploaded by

    NOCINPLUS

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    of 10
    Insert ogo here Document 10: Revision No, ‘User Requirement Speciation Effective Dat tates User Requirement Specification: User Requirement Specification [Document information, authorship and approvals [Author signs to confirm technical content Prepared by sob ie Signature Date Subject matter expert reviewer signs to confirm technical content. Reviewed by ob tte Signature Date [Quality representative signs to confirm document complies with quality management system authorised by: ob ie Signature Date ‘Document is curent front page has "Centvoled copy" stamped Page 1010 acumentib; I Insert ogo here vis <> ‘Uae RequrerentSpectaton Contents 1. Introduction 3 2. Objective 3 3. Scope 3 3. inscope 3 3.2, Out-of-Scope 3 4. — Criticality & Risk Assessment 4 4.4. Cricalty 4 42. Rik 4 43. Testing Requirements 4 Requirements 5 ‘Compliance Requirements 5 Process & Operational Requirements. 5 Constraints 6 Life-Cyde Requirements 6 Referenced Documents 9 Definitions ° Notes Fields marked [Company] or [Title], etc. can be updated within the document and should change all other references tothe fied instantly. All text provided is either instructional (red text) or example (black text) and should be modified/deleted as appropriate. Because URS can apply to very small and very large projects, itis dificult to provide examples of requirements to cover ll eventualties. The example text provided i for a small HVAC system, It demonstrates how requirements should be written, but clearly cannot cover requirements forall equipment types ‘Document is curentif frontpage has "Contoled copy” stamped Page 2of 10 Insert ogo here Decument 10: “ Revision No => ‘User Requirement Specification 1 3.1. 3.2. Introduction ‘This should be a very brief introduction how this URS has arisen and what its for. Company Name is procuring for their Company Address site. As part of this procurement, a User Requirements Specification (URS) is required. This URS documents the user and regulatory requirements for the User Requirement Specification. The URS will be used as the basis of design and qualification for the User Requirement Specification. Note: in some cases, the URS is not the basis for design, and in some other cases, ‘selection’ may be a more appropriate term where there is no design phase involved. It Is also possible that a URS has been prepared retrospective to order. In these cases, the introduction should make this clear and justify the position, Objective ‘The objective of this URS is to define and document the requirements of the User Requirement Specification at Company Address, including: + design + construction + qualification + operation Appropriate definition and application of these requirements will result in an operational. facility in compliance with all user requirements as well as applicable regulatory requirements. Scope What is in and out of scope may vary from one URS to another. These sections should be edited accordingly. In-Scope ‘The scope ofthis URS is limited to the User Requirement Specification at Company ‘Address. The plans and schedules provided in attachment 1 clearly identify the limit of supply. “The URS detals the following requirement types: * compliance requirements '* process and operational requirements + const * life cycle requirements: The URS describes all the requirements deemed relevant to the items above forthe User Requirement Specification, Testing for each requirement is determined through criticality and risk assessment as described in Section 4. Out-of-Scope This URS does not include: ‘Document is curentif frontpage has "Contoled copy” stamped Page 3010 Insert ogo here Decument 10: “ Revision No => ‘User Requirement Specification 4 41. 4.2. 43. «statutory construction requirements, considered the responsi their sub-contractors; ‘+ architectural or engineering functional or detailed design, considered the responsibilty of the contracted designers; + statutory requirements for occupational health, safety and environment, considered the responsibilty of the contracted designers. ‘+ The URS is not applicable to general office and other areas not directly required for the operation of the GMP facility ity ofthe builder and Criticality & Risk Assessment Criticality The User Requirement Spectication has been assessed in accordance with SOP002 - Grtcalty and Risk Assessment as follows: Parameter | Assessment | Justification Impact ‘One of For example Direc Product contact / controls etical parameters Indirect Monitors critical parameters / required for compliance Safety Personnel protection only None Not required for GMP or safety compliance Risk This URS has been completed in accordance with SOPO02 - Crticality and Risk Assessment. Each listed requirement has been assessed for risk and assigned a Risk Priority (High, Medium or Low). This risk priority should be used to make priorities for design andor testing requirements. Each risk priority identifies the risk to product quality and/or other risks as deemed relevant if the requirement is not implemented, or implemented incorrectly. The risk priority is determined by analysis of: ‘+ the severity of the risk event ‘+ the probability of detection before occurrence ‘© and the likelihood of its occurrence without intervention. This risk assessment has identified: 16 requirements of High risk priority 32 requirements of Medium risk priority 19 requirements of Low risk priority Testing Requirements Modify the level of testing required to sult the categorisations obtained. Based on the risk and criticality categorisations above and in accordance with SOP002 - Citicality and Risk Assessment for Validation and VMPXXX Validation Master Plan, User ‘Document is curentif frontpage has "Contoled copy” stamped Page 40f 10 Decument 10: “ Insert ogo here Revision No => ‘User Requirement Specification Requirement Specification requires Commissioning, followed by Design, Installation, Operational and Performance Qualification as minimum testing requirements. ‘The level of testing conducted for each requirement shall be commensurate with the risk priority identified in the requirements table in Section 5. 5. Requirements Ref. | Requirement Risk 5.1. Compliance Requirements List all compliance requirements which must be met by the completed project. GMP code(s) and guidances, ISO or national standards, OH&S requirements, building codes, corporate policies, etc. may be listed here. Redundancies (for example, building codes already referenced in tender packages or design briefs) should be avoided, however. ut. | eg. The User Requirement Specification shall comply with the M requirements of Good Manufacturing Practice (GMP) for medicinal products, as regulated by the Therapeutic Goods Administration (TGA) in ‘Australia (PIC/S Guide to Good Manufacturing Practice, PEOOS-8), U2 | e.g-The User Requirement Specification shall comply withthe relevant | M requirements for manufacture of Sterile Medicinal Products, as regulated by the TGA in Australia (PIC/S Guide to Good Manufacturing Practice, PE009-8, Annex 1), ua. 5.2. Process & Operational Requirements List all process and operational requirements to be met by the completed Project. Consider capacities, performance specications, layout, cleaning requirements, waste handling, environmental requirements, finishes, storage requirements, materials and personnel flows, etc. General eg. The system shall supply @ floor space of approximately 400m, us, |_ pattitoned as described in requirements U14 to U27, The system shall | have no less than 2 air handling units (AHU) to supply approximately 8m of air to the facity. €.9.Temperature control shall be by cooling and reheat cols in each AHU, us. | supplied by chilled and heating hot water systems dedicated to the HVAC. | M system. 6. ur. Finishes & Cleaning ‘Document scurentf front page has "Contoled copy” stamped age 5 of 10 DecumentiO: | siaeaeainl Revision No. ‘User Requirement Speciation us. | e.g, The insulation inside the ai handling units shal be non-sheading. | L us, | 9: The ar handing units shal be provided with adequate accessor | L cleaning. 5.3. Constraints List all constraints that define the boundaries/limitations of the project, and hich are not inherent inthe previously listed requirements. Consider space constraints, site service availability, project time constraints, site standards and policies, compatibility requirements with existing systems and equipment io, | &9: Scheduled modification to building structure works requires L completion and handover of the system prior to December 31, 2011. 49, The system shal be avalable 24 hours per day, 7 days per week. 11. | Routine maintenance events requiring system shut-down should be kept | M. to minimum, 5.4. Life-Cycle Requirements Define the post-design requirements for accepting the equipment, such as documentation, testing and warranty support. Design Review During the design phase, and as part of final design approval, design team meetings willbe ‘conducted. The outcomes ofthese meetings will be recorded and compiled by Company Name as the design review. ur e.g. The design review shall demonstrate thatthe design meets all H relevant user, functional, design, regulatory and compliance requirements, Commissioning Requirements {At the completion of installation, the system shall be commissioned by the installer and/or subcont minimum requirements for commissioning tractors tothe installer, prior to handover to Company Name. The following are the un eg. All personnel performing commissioning testing shall supply evidence | M of accreditation by a relevant testing authority (e.g. NATAY. usa, ‘eg. Tester shall supply documented evidence that the requirements of |] M ‘this URS have been met where appropriate. Handover Documentation Requirements us ‘eg. The installer shall supply an operation and maintenance manual M which includes as a minimum: ‘Document is curentif frontpage has "Contoled copy” stamped Page 6 of 10 Insert ogo here DecumentiO: | Revision No => ‘User Requirement Specification ‘> Identification of component parts and supple literature for all ‘components which may require replacement ‘+ Operating instructions for the system, and for individual ‘components where appropriate ‘+ As-built system layout drawings ‘+ Assbuit system specifications ‘+ Contact details for suppliers and maintenance contractor(s) + Preventative maintenance task lit with recommended frequencies QMS Documentation Requirements uss. e.g. Company Name shall ensure that the following SOPs have been created andor updated forthe system: ‘© operation + montoring + calibration ‘+ maintenance + dleaning Qualification Requirements ‘At the completion of commissioning, the system shall be qualified by Company Name and/or by consultants to Company Name, The follawing are the minimum requirements for qualification. rz, | ©: The system stall require nstalation, Operational and Performance | m, Qualification in accordance with the assessment performed in Section 4. 18. | e.9. Qualifcatios shall be completed prior to routine use ofthe system, | M Life-cycle Testing eg. All controling and monitoring sensors/displays for room pressure, | M to, | temperature and humiity shall be added tothe site calibration register and calibrated in accordance withthe frequency determined for each item. Maintenance zo, | ©The system shall be installed with a warranty period of no ess than | 12 months on all parts and labour. at, | 9 The routine preventative maintenance schedule shal be included on | M the site maintenance register. ‘Training ‘Document is curentif frontpage has "Contoled copy” stamped Page 7of 10 DecumentiO: | Insert ogo here Revision No => ‘User Requirement Specification 9 Training shall be provided to all operations and maintenance M 22. | personnel and cover operation, monitoring, cleaning, safety, calibration and maintenance. Training shall be documented and maintained, Change Control! 9. Changes made to the system after approval of the URS shall be M 23. | subject to change control. ‘Document is curentif frontpage has "Contoled copy” stamped Page 8 of10 Decument 10: “ Insert ogo here Revision No => ‘User Requirement Specification 6. Referenced Documents ‘The following documents may assist in the understanding of this specification Document Number | Document Title 7. Definitions Term/abbreviation | Definition ‘Document is curentif frontpage has "Contoled copy” stamped Page 9 of 10 Decument 10: “ inset ogee Revision No,

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