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Work Package

WP01

Description
Phase 1 Implementation of PQS

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1
1.1
1.2
1.3
1.4
1.5
1.6
1.7
1.8
1.8.1
1.8.2
1.8.3
1.8.4
1.8.5
1.8.6
1.9
1.9.1
1.9.2
1.9.3
1.9.4
1.9.5
1.10
1.11
2
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.8
2.9
2.10

Action Items

Level

Q1213 Notification to Management

SOP review vs PQS by SME

CAS Report Preparation
CAS Report Finalization
Site SOP Redline
Review by Internal SME CAS + Redline SOP
Approval of CAS + Redline SOP from Site Quality Head
CAS + SOP Redline Report Submission
Implement Changes At Site
Raise CCF
Allocation of CCF number
CFT Review
Address the comments
Approval CCF for Change
SOP Approval
Training on SOP
Upload SOP in ISOtrain
Training in ISOtrain
Identify Trainer
Prepare Training Material
Facilitated Training
SOP Effectiveness Date
QTS Go Live
Q1220 Regulatory Agency Inspection and Communication management
SOP Review by PQS by SME
CAS Report Preparation
Site SOP REdline
Review by Internal SME CAS + Redline SOOP
Approval of CAS + Redline SOP from Site Quality Head
CAS + SOP Redline Report Submission
Implement Changes At Site
Training on SOP
SOP Effectiveness Date
QTS Go Live

2
2
2
2
2
2
2
2
3
3
3
3
3
3
2
3
3
3
3
3
2
2
1

Target Date

Owner

Status

31-May-16

Shista D.

Closed
Closed

Shista D.
Shista D.
Shista D.

14-Mar-16

Shista D.
Shista D.

11-Apr-16
11-Apr-16
14-Apr-16
15-Apr-16
18-Apr-16
22-Apr-16

Shista D.
Shista D.
Shista D.
Shista D.
Shista D.
Shista D.

25-Apr-16
25-Apr-16

Shista D.
Shista D.

28-Apr-16

Shista D.
Shista D.
TBD

Status Action Date

Level
0
3

Status
Closed
Delayed