21CFR Part 11 (Software, computer, and electronic signatures)

Programming / Debugging

• Debugging and Programming
  Used VBA to modify, debug and augment an existing Access based dBase for storage of equipment, calibration, inventory, deliverables, material tree, inspections, label making, report making and documentation system tracking.

Validations – Black Box testing / validations only

• IQ/OQ/PQ validation protocol writing, execution and report
  • Blue Mountain (Equipment / Calibration Tracking software) execution and report
  • AssurX | CatsWEB (custom designed SQL based audit and CAPA (corrective action and preventive action) tracking program)
    • Revision of protocol per Part 11 requirements, Validation Plan, inclusion of functional requirements, creation of IQ/OQ/PQ sections, deleted redundancy and included acceptance criteria.
    • Execution of validation remotely on Target’s (subsidiary of Boston Scientific) server.
  • MS Access based documentation system protocol writing and execution.
  • Vendors & Parts (low end MRP system) writing of validation plan, and IQ/OQ/PQ.
  • MFG-Pro ERP system report modules.
  • SolidWorks Viewer
  • Excel Templates
  • LabView laser system
  • Backup/Archive System

V&V (validation and verification)

• Worked with CSS in developing FMEA, FTA, HA, Design Specifications, and validation plan for Immunoassay electronic custom software driven medical device.

Typical Protocol Development

• Validation Protocol – Validation Plan (Master Plan), IQ/OQ/PQ
  • Approval
  • Introduction
  • Ownership / responsibility
  • Overview
  • Discrepancy / Deviation Log and Report
  • Signature Log
  • References
  • Prerequisite Documentation
  • Test Equipment Log
  • Test Cases
    • Objective
    • System Prerequisite
    • Input Specifications
    • Output Specifications
    • Special Procedureal Requirements
    • Test Procedure
    • Contents of Tables / Attachments for execution
      • Procedural Steps
      • Expected Results
      • Actual Results
      • Pass / Fail
      • Initial Date at end of each page
      • Comments
      • Test Conclusion
      • Tester’s Signature
      • Verification Signature
  • Installation Qualification
    • Hardware testing
      • Access space
      • Power supply / UPS
      • Network communications
      • Interconnecting wiring / cabling
      • Ambient Temp  / Rh
      • Peripheral systems connections
    • Software testing
      • OS / Network and communication software
      • OEM software and custom software
      • Virus checking & Firewall
      • Verification of drive & RAM space
      • Drive configuration
      • Software version numbers
      • Security access for installation and operation
      • Directory configuration
      • Path modification
      • System Parameter configuration
  • Operation Qualification
    • Testing of specified range of inputs for a data field tested at each end of the range
    • Testing if illogical inputs are accepted
  • Performance Qualification (not always needed)
    • Executed on complex systems with multiple inputs and outputs as well as network-based systems during times of high user input and high data throughput.