PyroCycler (detailed specification coming soon)

• Introduction
• Key Features
• System requirements
• DQ-IQ-OQ-PQ and 21 CFR part 11
• What´s in the box?
• FAQ
• How can I purchase PyroCycler?
• Installation guide for PyroCycler

Introduction

PyroCycler utilizes Peltier elements and integrated software for efficient cooling and heating.

DQ-IQ-OQ-PQ and 21 CFR part 11

Regulatory compliance in the pharmaceutical, biotechnology, and medical device, industries is the foundation of good business practices. DQ-IQ-OQ-PQ documents for PyroCycler provide significant support to reduce the risk of non-compliance.

DQ (Design Qualification) - is the foundation of good science & good compliance practices. You cannot get more out of a system that has been built into it. DQ is the tool & methodology to make the evaluation of suitability for specific requirements, including worst-case-scenario. DQ also provides the baseline for meaningful Performance Qualification (PQ) monitoring; without DQ, PQ flounders, it does not exist. 21 CFR Part 11 compliance is a major functionality relative to Design Qualification.
In the first part let us consider what may be the most important questions to ask relative to 21 CFR Part 11 DQ.

DQ supports the functional & quality specifications designed into PyroCycler. Documentary proof of DQ compliance includes:

1. Software Validation Plan,
2. Software Validation Summary,
3. 21 CFR Part 11 Validation Summary,
4. Measurement Performance Design Summary, and
5. Measurement Compliance Summary

IQ (Installation Qualification) - IQ supports the requirement for proper installation and acceptance qualification for PyroCycler. Documentary proof of IQ compliance includes:

1. Receipt & acceptance checklist,
2. Physical & electrical compliance checklist,
3. Environmental compliance checklist,
4. Training compliance checklist, and
5. Final IQ Summary

OQ (Operational Qualification) - OQ supports the specification compliant functioning of the system. Documentary proof of OQ compliance includes:

1. 21 CFR Part 11 operational specification checklist,
2. Software operational specification checklist,
3. Instrument interface operational specification checklist,
4. Instrument operational specification checklist, and
5. Final OQ Summary

PQ (Performance Qualification) - PQ supports quality evaluation & quality compliance management of the system. PQ compliance models include:

1. 21 CFR Part 11 compliance models,
2. SQC models for instrument qualification review,
3. SQC models for method qualification review,
4. SQC models for vendor qualification review, and
5. SQC models for OOS investigations