Validation Report Flashcards
1
Q
Introduction
A
- Overview of system/equipment being validated
- Purpose of validation
- Scope
2
Q
Validation Protocol
A
Procedures and acceptance criteria used to validate the system/equipment
1. Scope
2. EQ
3. IQ
4. OQ
5. PQ
6. Acceptance Criteria
7. Roles and responsibilities
3
Q
Validation Activities
A
Validation activities that were performed
include any deviations or non-conformances
1. DQ
2. IQ
3. OQ
4. PQ
5. Acceptance criteria
4
Q
Results
A
Results of validation activities
meets all regulatory requirements - fit for use
1. DQ
2. IQ
3. OQ
4. PQ
5
Q
Conclusions
A
- Summarise results
- Validated or not?
- How were issues (if any) adressed?
6
Q
Recommendations
A
Any further actions needed to ensure system stays validated?
1. Ongoing monitoring
2. Training
3. Change control
4. Risk management
5. Documentation
7
Q
Signatures & approvals
A
From all relevant stakeholders
