GxP Compliance Software Evaluation Checklist Form
GxP Compliance Software Evaluation Checklist
Software Name
*
Software Vendor
*
Software Version
Intended Use / Application Area
*
Please Select
Laboratory Data Management
Manufacturing Execution
Document Management
Quality Management
Equipment Monitoring
Other
Compliance Areas Checklist
*
Rows
Yes
No
Partially
Not Applicable
Data Integrity Controls
1
2
3
4
Audit Trail Functionality
5
6
7
8
User Access Management
9
10
11
12
Electronic Signatures
13
14
15
16
Change Control
17
18
19
20
System Validation
21
22
23
24
Record Retention
25
26
27
28
Overall Ease of Use
*
1
2
3
4
5
Quality of Vendor Support
*
1
2
3
4
5
Documentation Quality
*
1
2
3
4
5
Key Strengths
Areas for Improvement / Concerns
Submit Evaluation
Should be Empty: