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Where are you now? Intelligence Services > 21 CFR Part 11 > Products > Competency Training (CACTUS) > Desktop Edition

CACTUS Desktop Edition (CDE) 21 CFR Part 11 Compliant
Computer Aided Competency Training & Assurance System



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,

  • Bringing meaningful training, such as 21 CFR Part 11, into the real world,
  • Integrating Just-In-Time Training (JITT) for best practices,
  • Assessing & measuring employees' competencies,
  • Developing learning paths, and
  • Providing creative content for training retention.
  • Key features

  • 21 CFR Part 11 compliant design & functional specification
  • Graphical UI with integrated browser provides free-flow access to every function
  • A library of on-line automatic training courses are available
  • A library of on-line automatic examinations are available
  • On-line explanation facilitator
  • Monitoring of time used during training & examinations
  • IQ-OQ-PQ training management
  • Certificate of Competency (CoC) generation
  • Learning objectives are integrated to tests and content
  • Statistical Quality Control of learning objectives supports training validation
  • Training Needs Analysis
  • Training Examination Analysis
  • Training Metrics & Performance Management
  • Financial Management Integrated to Training Quality Improvement
  • Scheduling database
  • Course management database
  • Trainee management database
  • System requirements

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

  • Pentium 200 MHz MMX compatible CPU
  • 64 MB RAM
  • Windows 98, ME or NT 4.0 SP6+ or 2000 SP1 or XP operating system
  • 24x CD ROM drive
  • 250 MB free hard disk space
  • 800x600 high color display setting (true color recommended)
  • Installation pre-requisites

  • SP 6 for NT 4.0
  • Internet Explorer 5.5 (or above)
  • SQL Server 7.0/MSDE 1.0 with SP 3 (or above)
  • SQL Server 2000/MSDE 2.0 with SP 1 (or above)
  • 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. STOP

    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
    21 CFR Part 11 Issues
    Various aspects of electronic records and electronic signatures
    Forum Database
    Almost 100,000 searchable messages from 16 working newsgroups. Updated regularly.
    Warning Letters Knowledge Base
    An extremely versatile database that will assist familiarization with the regulatory requirements
    Competency Trainings & Exams
    Multimedia enriched learning materials, exercises and exams.
    On-line Trainings & Exams
    Web-based learning materials, exercises and exams

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