# Work Package1 WP01

Description #Phase 1 Implementation of PQS 1

1.11.21.31.41.51.61.71.8

1.8.11.8.21.8.31.8.41.8.51.8.6

1.91.9.11.9.21.9.31.9.41.9.51.101.11

22.12.22.32.42.52.62.72.82.9

2.10

Action Items LevelQ1213 Notification to Management 1

SOP review vs PQS by SME 2CAS Report Preparation 2CAS Report Finalization 2Site SOP Redline 2Review by Internal SME CAS + Redline SOP 2Approval of CAS + Redline SOP from Site Quality Head 2CAS + SOP Redline Report Submission 2Implement Changes At Site 2Raise CCF 3Allocation of CCF number 3CFT Review 3Address the comments 3Approval CCF for Change 3SOP Approval 3Training on SOP 2Upload SOP in ISOtrain 3Training in ISOtrain 3Identify Trainer 3Prepare Training Material 3Facilitated Training 3SOP Effectiveness Date 2QTS Go Live 2Q1220 Regulatory Agency Inspection and Communication management 1SOP Review by PQS by SMECAS Report PreparationSite SOP REdlineReview by Internal SME CAS + Redline SOOPApproval of CAS + Redline SOP from Site Quality HeadCAS + SOP Redline Report SubmissionImplement Changes At SiteTraining on SOPSOP Effectiveness DateQTS Go Live

Target Date Owner Status Status Action Date31-May-16 Shista D. Closed

Shista D. ClosedShista D.Shista D.

14-Mar-16 Shista D.Shista D.

11-Apr-16 Shista D.

11-Apr-16 Shista D.

14-Apr-16 Shista D.

15-Apr-16 Shista D.

18-Apr-16 Shista D.

22-Apr-16 Shista D.

25-Apr-16 Shista D.

25-Apr-16 Shista D.

28-Apr-16 Shista D.Shista D.

TBD

c

Level Status

0 Closed3 Delayed