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8 7. CSV CSV 7-1 Planning Phase CSV Requirement Phase Design & Build Phase DQ Test & Deployment Phase IQ OQ PQ Operation Phase Retirement Phase Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 8

9 Planning Phase 3) 4) 5) 6) 7) 8-1 User Requirements Specification User PM PO URS Risk Assessment Report QA QAM RAR Validation Master Plan VM PM User PO VMP QA SSM Package Assessment Plan PJM PJM PM PAP Package Assessment Report PJM PJM PM PAR Vendor Audit Report PJM PJM QA PM VAR ) 2) 3) 4) 5) QA 1) GXP 21 CFR Part 11 GXP 21 CFR Part 11 2) FDA 3) 4) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 9

12 8.2 Requirement Phase 1) 8-2 Function Specification PJM DEV VM PM FS Functional Risk Assessment PJM VM QA PM FRA Package Configuration PJM DEV VM PM PC ) 2) 3) CASE GUI OQ 1) 2) 3) 4) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 12

13 High Middle Low OQ PQ High OQ High PQ 8.3 Design & Build Phase 1) 2) 3) 4) 5) 6) 8-3 Design Specification DEV PJM VM PM DS DQ DQ Report PJM DEV VM QA PM DQR Test Plan VM User QA PM TSP Data Migration Plan PJM User VM PM DMP Deployment Plan PJM User VM PM DP ) 2) 3) 4) 5) 6) 7) 1) 2) (1) (2) (3) 3) 4) 5) 6) 7) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 13

15 8.4 Test & Deployment Phase 1) 2) 3) 4) 5) 6) 7) 8) 9) 10) 11) 12) 8-4 IQ IQ Plan VM DEV QA PM IQP IQ IQ Script DEV PJM VM PM IQS IQ IQ Log DEV PJM VM PM IQL IQ IQ Report VM DEV QA PM IQR OQ OQ Plan VM DEV QA PM OQP OQ OQ Script PJM PJM VM PM OQS OQ OQ Log PJM PJM VM PM OQL OQ OQ Report VM DEV QA PM OQR PQ PQ Plan VM User QA PM PQP PQ PQ Scenario VM User PM PQSN PQ PQ Script PJM VM PM PQS PQ PQ Log User VM PM PQL PQ PQ Report VM User PM QA PO PQR System Access Plan PJM User VM PM SAP SSM User Manual PJM User VM PM UM User Support Material PJM User VM PM USM Service Level Agreement PM User VM PO SLA Data Migration Report PJM VM User PM DMR Disaster Recovery Plan PM VM SSM DRP Validation Report VM PM User QA PO VR System Release Notification PM PO SRN Support Quality Plan SM PM QA SSM SQP IQ IQ IQ IQ IQ Installation QualificationIQ IQ Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 15

16 OS IQ IQ IQ IQ IQ IQ IQ IQ IQ IQ IQ IQ IQ IQ IQ IQ IQ IQ IQ IQ OQ OQ OQ Operation Qualification High Risk OQ Middle Risk Low Risk OQ OQ OQ OQ OQ OQ OQ OQ OQ 1) OQ 2) 3) 4) OQ OQ OQ OQ OQ OQ Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 16

17 OQ OQ OQ OQ OQ OQ OQ OQ PQ PQ PQ PQ Performance Qualification PQ PQ PQ PQ PQ 1) 2) 3) 4) 5) OQ 6) 7) PQ High Risk PQ Middle Risk Low Risk PQ PQ PQ PQ PQ PQ PQ PQ PQ PQ PQ PQ PQ PQ PQ PQ PQ PQ PQ PQ PQ PQ PQ Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 17

20 8.5 Operation Phase 1) 2) 3) 8-5 Periodic Audit Report QA QAM PAR Migration Report SM User SSM MR Support Quality Report SM PM QA SSM SQR ) 2) 3) Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 20

21 8.6 Retirement Phase 1) 8-6 Retirement Plan PM VM QA PO RP Retirement Report PM VM QA PO RR GXP 8.7 1) 2) 3) 4) 5) 8-7 Change Control Plan VM PJM PM CCP Change Request Form CRF Change Request Log PJM SM CRL Incident Management Plan VM PJM SM PM SSM IMP Incident Report IR Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 21

22 Incident Log PJM SM IL Document Management VM User PM DMP Plan Document Index DA DI Training Plan PJM User PM PO TP Traceability Matrix TMX A B A B Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 22

24 ) 2) 3) OQ OQ 4) PQ PQ 5) 9. SOP SOP 9-1 SOP SOP SOP CSV-0010 CSV CSV-0020 CSV-0030 CSV Guideline CSV-0040 CSV-0101 CSV-0102 CSV-0103 CSV-0104 CSV-0105 CSV-0201 CSV-0301 CSV-0302 DQ DQ CSV-0303 CSV-0304 CSV-0305 Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 24

25 SOP SOP CSV-0401 IQ IQ IQ IQ CSV-0402 OQ IQ OQ OQ OQ CSV-0403 PQ OQ PQ PQ PQ PQ PQ CSV-0404 CSV-0405 CSV-0406 CSV-0407 CSV-0408 CSV-0501 CSV-0601 CSV-0901 CSV-0902 CSV-0903 CSV-0904 CSV CATEGORY 1 MS Windows NT MS Windows 2000 Oracle CATEGORY 2 ph CATEGORY 3 Copyright(C) 2006 ecompliance Ltd. All Rights Reserved. Page 25

30 OFF Ion Torrent Ion Torrent Ion AmpliSeq Ion Chip Ion 314 Chip Kit v2 BC 8 pack , ,000 Ion 316 Chip Kit v2 BC 8 pack

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