MASTER COPY us REQUIREMENT SPECIFICATIONS KARKAPATLA INDIAN IMMUNOLOGICALS LIMITED UNCOSIRR@HERED COPY } PDF SOFTWARE FOR ALLOTMENT OF BATCH NUMBERS ON AUTHORIZED SCANNED DOCUEMNTS i.e BMRS, BFRs, BPRs, LPRs, MPRs etc. Department/Section: Quality Assurance / Documentation | URS No. KH/URS/300-00 Table of Contents lL URS APPROVAL AND AUTHORIZATION, 2 OBJECTIVE. 3. SCOPE. 4. REQUIREMENTS 4.1 Process / Product Requirements 4.2 Operational Requirements. 43. GMP Requirements 44 HSE Requirements 4.5 Documentation Requirement: 5. REFERENCES.. 6. ABBREVIATIONS. 7. REVISION HISTORY. J. URS APPROVAL AND AUTHORIZATION Prepared By:E Secapel Yun Srv Coeunbine OA (Designation and Department) Reviewed By: Chawdootiant Hague Dy. ronge= @A (Name) ‘Designation tnd Department) Approved By: Ci Kawadeh — DePuy named er om (ame) (Designation and Department) Authorized By: Q Ano) G war GMM (Name) (Designation and Department) Effective Date: 27-07-2022 L- f URS Template Ref, No. QP-QMS-020.00/A3 Confidential Zager (Sign and date) Cea (Sign and date) oUeeeh (Gign and date) v Page 1 of 3INDIAN IMMUNOLOGICALS LIMITED UNCON PROEEED COPY USER REQUIREMENT SPECIFICATIONS ® KARKAPATLA PDF SOFTWARE FOR ALLOTMENT OF BATCH NUMBERS ON AUTHORIZED SCANNED DOCUEMNTS i.e BMRS, BFRs, BPRs, LPRs, MPRs etc. Department/Section: Quality Assurance / Documentation | URS No. KH/URS/300-00 2. OBJECTIVE © This document specifies the requirement for PDF software for allotment of Batch numbers on Authorized scanned documents. 3. SCOPE * The scope of this User Requirement Specifications is applicable for Quality Assurance documentation system. 4, REQUIREMENTS 4.1 Process / Product Requirements 4.11 Name of the Equipment/System/Facility © PDF software 4.1.2 Purpose of the Equipment/System/Facility * To have provision for editing of Batch numbers in Header and footers on all pages at a time in Scanned Authorized document. * While editing the Header section, the batch number will come on all pages at a time irrespective of portrait and landscape layouts. * While editing the document the content of the document should not delete ie. delete option should be disabled. 4.13 Number of Equipment/System/Facility required ‘© Software shall be installed in 6 computer systems for regular usage. 4.14 Suggested capacity and model with supplier’s name Supplier: © Asper the requirements of IT team, 4.1.5 Any other Specific Requirement NA 42 Operational Requirements ° NA 43 GMP Requirements = °ONA 4.4 HSE Requirements * NA 4.5 Documentation Requirements © Operation Manual © Demo training ‘URS Template Ref. No. QP-QMS-020.00/A3 Confidential Page 2 of 3MASTE ‘USER REQUIREMENT SPECIFICATIONS INDIAN IMMUNOLOGICALS LIMITED KARKAPATLA UNCONTROLERD COPY 6 PDF SOFTWARE FOR ALLOTMENT OF BATCH NUMBERS ON AUTHORIZED SCANNED DOCUEMNTS i.e BMRS, BFRs, BPRs, LPRs, MPRs etc. Department/Seetion: Quality Assurance / Documentation | URS No. KH/URS/300-00 © Licensure validity 5. REFERENCES oN 6. ABBREVIATIONS Abbreviations Full form _ NA Not applicable PDF Portable document format BMR Batch manufacturing record BFR 1 Batch filling record BPR Batch packing record LPR Lot processing record MPR ‘Media preparation record 7. REVISION HISTORY Change Control No/ Approval Date Revision Previous Version Effective Date | i. number NA 00 New Changes Made: New URS prepared. ‘URS Template Ref, No. QP-QMS-020,00/A3 Confidential Page 3 of 3