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CERF ELN, IQOQPQ Validation

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This slideshow is a description of the IQOQPQ Validation process used by Lab-Ally to Validate CERF Electronic Lab-Notebook(ELN). The process is broken down into installation qualification, operational qualification, and performance qualification. Each of these items is described with respect to CERF software, and the slideshow provides example validation activities for these items. The slideshow also contains a brief introduction to CERF software functionality and capabilities.

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CERF ELN, IQOQPQ Validation

  1. 1. cerf-notebook.com
  2. 2. CERF IQ,OQ,PQ
  3. 3. 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
  4. 4. Installation Qualification Operational Qualification Performance Qualification Validation Plan CERF IQ,OQ,PQ
  5. 5. 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
  6. 6. CERF IQ,OQ,PQ
  7. 7. 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
  8. 8. CERF IQ,OQ,PQ
  9. 9. Validation Plan Customer Input Performance Qualification DefinedValidation Activities 1... 2... 3... 4... Acceptance Criteria Performance Qualified CERF IQ,OQ,PQ
  10. 10. About CERF 5.0 Why CERF? CERF IQ, OQValidation About Lab-Ally http://cerf-notebook.com/contact/
  11. 11. 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/

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