|
|
Impact |
|
|
|
|
|
H |
M |
L |
|
|
|
Likelihood |
H |
1 |
1 |
2 |
|
Level 1 |
Highly probable, severe adverse event |
M |
1 |
2 |
3 |
|
Level 2 |
Moderately probable mid severity adverse event |
L |
2 |
3 |
3 |
|
Level 3 |
Improbable low severity adverse event |
Farmatec Engineering provides updated validation documentation that meeting regulatory requirement. We provide validation  service for utilities and machinery only. Our documentations (depend on different utilities) included :
- RISK ANALYSIS
- FUNCTIONAL SPECIFICATION
- DESIGN SPECIFICATION
- DESIGN QUALIFICATION
- INSTALLATION QUALIFICATION
- OPERATIONAL QUALIFICATION
- TRACEBILITY MATRIX
As added value services, we also assist customer to prepare user requirement specification and standard operating procedure for the utilities.
|
|
Probability of detection |
|
|
|
|
|
L
|
M |
H
|
|
|
|
Classification |
1
|
H
|
H
|
M
|
|
Low
|
Low Priority |
2
|
H
|
M
|
L
|
|
Moderate |
Medium Priority |
3
|
M
|
L
|
L
|
|
High
|
High Priority |
|
Emphazise in understanding customer’s requirement and needs