CACTUS Desktop Edition (CDE)
Computer Aided Competency Training & Assurance System

• Introduction
• Key features
• System requirements
• DQ-IQ-OQ-PQ and 21 CFR part 11
• What´s in the box?
• FAQ
• How can I purchase CACTUS Desktop Edition (CDE)?
• Installation guide for CDE, courses, and examinations
• Upgrade to Enterprise Edition
• Competency Courses & Examinations
• On-line Competency Courses & Examinations

Introduction

CACTUS is the only product on the market which provides Total Quality Management for your competency training requirements. By utilizing multimedia content and real world scenarios for your competency training, training validation & management, you can motivate your team to use their training to the fullest. The competency Training Decision Support (TDS) sub-system includes Training Needs Analysis and Training Examination Analysis to implement meaningful Just-In-Time Training (JITT). In addition to JITT, TDS expands the utility of CACTUS by adding new dimensions to human resource management, development of knowledge workers, and corporate engineering.

As with any other budget item, training dollars are expenditures whose return on investment can be crucial to a corporation's success. CACTUS maximizes your ROI by,

Key features

System requirements

To successfully install the CACTUS Desktop Edition onto your computer, ensure that your system meets the following minimum requirements.

Installation pre-requisites

The freely distributable versions of the above components are included on the Install CD.

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 CACTUS 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 CACTUS. 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 CACTUS. 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