Applicable Customer

QMS Process
Documents/Resources Service
Quality Manual QM-01 X
Document and Records Mgmt SOP-01 X
Management Responsibility SOP-02
Design & Development SOP-03
Risk Management SOP-04
Supplier Evaluation SOP-05
Purchasing SOP-06 X
Customer Orders SOP-07 X
DMR SOP-08
Nonconformance SOP-09
CAPA SOP-10
Complaint Handling SOP-11 X
Customer Feedback SOP-12 X
Adverse Event SOP-13
Reporting Corrections SOP-14
Master Validation SOP-15
Software Validation SOP-16
Calibration SOP-17
Training SOP-18
Internal Audit SOP-19
PMS SOP-20
Traceability SOP-19
PMCF SOP-20
Strategy for Reg. Compliance SOP-21

X indicates training is required for group. In addition to the SOP, the groups shall be trained on the support
 Engineering/ Executive Functional Production/
Design Management Managers Ops
X X X X
X X X X
X X
X
X
X
X X X X
X
X
X X X
X X
X X
X X

X X
X X
X
X

X
X X
X
X X

ups shall be trained on the supporting Wis and Forms.

X X
X X
X

X X
X
X
X
X
X
X
X
X
X
X

X
X
[Dept/Group]
Quality Title Document Description Customer Service
Manual
Document and QM-01 Quality Manual X
Records
ManagementMgmt SOP-01 Document and Records Mgmt X
Responsibility
Design & SOP-02 Management Responsibility
Development
Risk SOP-03 Design & Development
Management
Supplier SOP-04 Risk Management
Evaluation SOP-05 Supplier Evaluation
Purchasing
Customer SOP-06 Purchasing X
Orders SOP-08 Customer Orders X
DMR
Nonconforma SOP-09 DMR
nce SOP-10 Nonconformance
CAPA
Complaint SOP-11 CAPA
Handling
Customer SOP-12 Complaint Handling X
Feedback SOP-13 Customer Feedback X
Adverse Event
Master SOP-14 Adverse Event
Validation
Software SOP-16 Master Validation
Validation SOP-17 Software Validation
Calibration SOP-19 Calibration
Training SOP-21 Training
Internal Audit SOP-22 Internal Audit
PMS SOP-23 PMS
Traceability SOP-24 Traceability
PMCF
Reg. SOP-25 PMCF
Compliance SOP-26 Strategy for Reg. Compliance

User Groups are created with Greenlight Guru and based upon organization Roles a
X indicates training is required for group. In addition to the SOP, the groups shall be
 Engineering/Design Executive Management Functional Managers Production/Ops
X X X X
X X X X
X X
X
X
X
X X X X
X
X
X X X
X X
X X
X X

X X
X X
X
X

X
X X
X
X X

sed upon organization Roles and Responsibilities.

X X
X X
X

X X
X
X
X
X
X
X
X
X
X
X

X
X