Vertically Integrated Solutions

Alright, let's dive into the rigorous testing and validation procedures that are absolutely essential when integrating custom automation into cGMP-compliant environments. This isn't just about making the machine move; it's about proving it performs reliably, consistently, and within strict specifications.

Comprehensive Testing and Validation Protocol:

01 Design Qualification (DQ):

• This is the foundation. We meticulously document the design specifications, ensuring they meet all cGMP requirements, user needs, and regulatory standards.

• We perform risk assessments (e.g., FMEA) to identify potential failure modes and implement mitigation strategies.

• We review material certifications and component specifications to ensure they meet quality and traceability requirements.

02 Factory Acceptance Testing (FAT):

• Before the machine even ships, it undergoes rigorous testing at our facility.

• This includes:

  • Functional Testing: Verifying that all mechanical, electrical, and software components operate as intended.

  • Performance Testing: Measuring cycle times, throughput, and accuracy to ensure they meet design specifications.

  • Software Validation: Testing all software functions, including data acquisition, control algorithms, and user interfaces.

  • 3D Vision System Calibration and Verification: Ensuring the 3D vision system accurately measures and inspects parts.

  • Robotic Accuracy and Repeatability Testing: Verifying the robot's ability to perform precise movements and assembly tasks.

  • Safety Testing: Verifying all safety interlocks, emergency stops, and other safety features.

  • Part verification testing: Running known good and bad parts to confirm the proper operation of the part verification systems.

  • All testing is documented, and any deviations are addressed before the machine is approved for shipment.

03 Site Acceptance Testing (SAT):

• Once the machine is installed at your facility, we perform SAT to ensure it operates correctly in its intended environment.

• This includes:

  • Verification of installation and connections.

  • Re-testing of critical functions and performance parameters.

  • Integration testing with your existing systems (e.g., MES, ERP).

  • Testing with your specific parts and materials.

  • Environmental testing ensures the machine operates within your facility's environmental parameters.

04 Installation Qualification (IQ):

• We document the installation process, verifying that the machine is installed according to the manufacturer's specifications.

• This includes verifying the calibration of instruments, connections, and utilities.

05 Operational Qualification (OQ):​

• We demonstrate that the machine operates within its specified operating ranges.

• This includes:

  • Testing of critical process parameters (e.g., temperature, pressure, speed).

  • Testing of alarm and interlock functions.

  • Verification of data acquisition and logging systems.

  • Testing the system's response to error conditions.

  • Running a series of test parts to verify that the machine produces conforming parts.

06 Performance Qualification (PQ):

• We demonstrate that the machine consistently produces products that meet predetermined acceptance criteria.

• This involves running multiple production batches and collecting data to verify process capability and product quality.

• This is where we confirm the part error detection systems function as designed and that the machine's ability to create robust product assembly is proven.

07 Ongoing Monitoring and Maintenance:

• After PQ, we establish a schedule for ongoing monitoring, calibration, and maintenance.

• This includes:

  • Regular performance checks.

  • Preventive maintenance.

  • Calibration of instruments.

  • Software updates and patches.

  • Full documentation of all events.

Documentation is Key:

• Every step of the testing and validation process is meticulously documented.

• This documentation forms a critical part of your cGMP compliance records.

• It also provides valuable data for process improvement and troubleshooting.

• By adhering to these rigorous testing and validation procedures, we ensure that our custom automation systems meet the highest standards of quality, reliability, and compliance.