Digital validation protocols for industrial automation. Manage Installation, Operational, and Performance Qualification with complete traceabilityβensuring compliance from day one.
A structured approach to equipment validation ensuring your automation systems meet all regulatory and quality requirements.
IQ Protocol
Verify that equipment is installed correctly according to specifications and manufacturer requirements.
OQ Protocol
Confirm that equipment operates as intended across all specified operating ranges.
PQ Protocol
Demonstrate that equipment consistently produces results meeting predetermined specifications.
Everything you need to manage validation protocols, documentation, and compliance tracking.
Pre-built IQ/OQ/PQ protocol templates designed for automation equipment including robots, PLCs, vision systems, and safety devices.
Automatic mapping of requirements to test cases ensuring complete coverage and easy audit preparation.
Structured deviation reporting when tests fail or differ from expected results, with root cause tracking.
21 CFR Part 11 compliant electronic signatures with complete audit trails for all approvals.
Auto-generated validation summary reports with executive dashboards and compliance metrics.
Controlled change management for approved validation protocols with version tracking.
Comprehensive forms to verify proper installation of automation equipment.
Serial numbers, model numbers, software versions for all automation components
Electrical, pneumatic, and network connectivity verification
Confirmation all ordered components received and installed
Verification manuals, drawings, certificates are complete
PLC, robot, vision, and HMI software verification
Compiled certificates for all calibrated components
IP addresses, device names, communication settings
E-stops, light curtains, interlocks properly installed
Functional testing documentation to verify equipment operates as intended.
Step-by-step test procedures with pass/fail criteria
Repeatability, accuracy, and payload verification
Gage R&R, measurement accuracy, inspection reliability
I/O testing, sequence verification, alarm testing
E-stop response, safety circuit verification
Network communication, data exchange verification
Temperature, humidity, vibration response
Operation at specification limits
Response to induced faults
Production performance validation to ensure consistent quality output.
Sustained operation at production speeds
Statistical validation of process performance (Cp, Cpk)
Confirmation of throughput requirements
Defect rates during validation runs
Extended run documentation
Executive summary of qualification results
Complete your validation packages with essential supporting documents that ensure audit readiness and regulatory compliance.
Documentation when tests fail or differ from expected results
Calibration status of equipment used during validation
Requirements to test case mapping
Changes to approved validation protocols
See how much time and money you can save by digitizing your IQ/OQ/PQ validation protocols and documentation.
Reuse protocol templates across similar equipment
Auto-generate requirement-to-test matrices
Complete validation packages at your fingertips
Free up 1.32-8.1 FTE for higher-value engineering work
Annual manpower typically spent on validation documentation without a digital solution.
| Activity | Hours/Project | Projects/Year | Annual Hours | FTE Equivalent |
|---|---|---|---|---|
| IQ Protocol Development | 40-80 | 5-15 | 200-1,200 | 0.1-0.6 |
| IQ Execution/Documentation | 80-160 | 5-15 | 400-2,400 | 0.2-1.2 |
| OQ Protocol Development | 80-160 | 5-15 | 400-2,400 | 0.2-1.2 |
| OQ Execution/Documentation | 160-320 | 5-15 | 800-4,800 | 0.4-2.4 |
| PQ Protocol Development | 40-80 | 5-15 | 200-1,200 | 0.1-0.6 |
| PQ Execution/Documentation | 80-160 | 5-15 | 400-2,400 | 0.2-1.2 |
| Deviation Management | 8-24 | 20-50 | 160-1,200 | 0.08-0.6 |
| Summary Report Creation | 16-40 | 5-15 | 80-600 | 0.04-0.3 |
| TOTAL | β | β | 2,640-16,200 | 1.32-8.1 |
π‘ Key Insight: Organizations spend 2,640-16,200 hours annually on validation documentationβequivalent to 1.32-8.1 FTE. ValidateIQ Pro can reduce this by 50-70% through protocol templates, automated traceability, and streamlined deviation management.
Join leading manufacturers who have cut validation time in half while achieving 100% FDA/GMP compliance.