The document outlines the installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) processes for CERF software. It details the steps for IQ including package download integrity, software installation, and configuration. For OQ, it lists desktop, automaton, and web client qualification. The validation plan section describes getting customer input and defined validation activities. It provides links to additional CERF and Lab-Ally resources.

4. cerf-notebook.com

6. CERF IQ,OQ,PQ

7. Installation Qualification
Operational Qualification
✓ System Hardware
✓ Package Download Integrity
✓ Software Unpacking
✓ Database Backup
□ First-Time Login
□ Business PolicyConfiguration
□ etc...
✓ Compliant SignatureWorkflow
✓ Admin Permissions
✓ Resource Metadata
□CERF Search Engine
□User Credentials
□Controlled Documentation
□ etc...
CERF IQ,OQ,PQ

8. Installation Qualification
Operational Qualification
Performance Qualification
Validation
Plan
CERF IQ,OQ,PQ

10. Installation Qualification
(IQ)
Customer Kickoff
Packet
Minimum System
Requirements
Yes No
Customer
System
Installation Package
Integrity
Installation
Package
Yes No
Installation Process
Yes No
Configuration
Startup
Procedure
Installation
Process
Documentation
No Yes
Server Directory
Hierarchy
Yes
No
Backup Procedure
YesNo
Installation Qualified
Validation
Plan Legend:
Start/Stop
Input/output
Process
Decision
CERF IQ,OQ,PQ

11. CERF IQ,OQ,PQ

12. Operational Qualification (OQ)
Desktop Client Qualification
Automaton Qualification (If user has
Automaton Client)
Web Client Qualification
CERF
Functional
Specifications
Document
Yes
Operational
Qualification
Successful
Validation
Plan
OQ Test Procedures
CERF IQ,OQ,PQ

13. CERF IQ,OQ,PQ

14. Validation Plan
Customer Input
Performance Qualification
DefinedValidation Activities
1...
2...
3...
4...
Acceptance
Criteria
Performance Qualified
CERF IQ,OQ,PQ

17. About CERF 5.0
Why CERF?
CERF IQ, OQValidation
About Lab-Ally
http://cerf-notebook.com/contact/

18. https://www.fda.gov/downloads/MedicalDevices/.../ucm085371.pdf
http://lab-ally.com/products/cerf-eln/e-lab-notebook/
lab-ally.com/
http://cerf-
notebook.com/