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

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

   






Introduction

CACTUS is the only competency training & management system on the market that can be upgraded into a Knowledge Executive Suite. CACTUS Enterprise Edition (CEE) extends the capabilities of the CACTUS Desktop Edition (CDE) into Knowledge Management and Knowledge Resource Engineering. How? In addition to the competency training sub-systems of the CDE, CEE includes Competency Information Management and SOP Management sub-systems with integrated task management and knowledge item modules. Competency modules, tasks, knowledge items, learning objectives, components, and test results can be interconnected to form a knowledge-vector database. Utilizing the METAN (Metrics & Analysis) decision support subsystem, we are able obtain in-depth knowledge models about employees, departments, positions, and the enterprise. A very unique and attractive characteristic of CACTUS is that you can start with a very simple, intuitive, and compliant competency training system and move up naturally to a very sophisticated enterprise knowledge system.

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
  • Intranet integrated browser provides free-flow access to every function
  • Supports hybrid training
  • Library of on-line automatic training courses are available
  • Library of on-line automatic examinations are available
  • On-line explanation facilitator
  • Time-used monitoring of 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
  • Extensive Course Management database
  • Extensive Trainee Management database
  • SOP Management sub-system
  • Integrated task & knowledge item management
  • SOP Integrity Analysis
  • Competency Information Management System
  • METAN - the Metrics and Analysis sub-module supports Decision Management
  • METAN - Knowledge Management
  • METAN - Knowledge Resource Engineering
  • System requirements

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

    CACTUS Enterprise Edition Server installation

  • 500 MHz Pentium or compatible CPU
  • 256 MB RAM
  • 24x CD ROM drive (32x recommended)
  • 10 GB free hard disk space
  • TCP/IP LAN
  • MS Windows 2000 Server SP1+ or XP
  • MS Internet Information Server 5.0+
  • MS Internet Explorer 5.5+
  • MS SQL Server 7.0 SP3+ or 2000 SP1+
  • CACTUS TC Client installation

  • 200 MHz Pentium or compatible CPU
  • 64 MB RAM
  • 50 MB free hard disc space
  • CD ROM drive (min. 24x if multimedia materials are kept on CD)
  • TCP/IP LAN
  • 800x600 high color display (true color recommended)
  • 16 bit Sound card
  • Windows 98, ME or NT 4.0 SP6+ or 2000 SP1 or XP operating system
  • MS Internet Explorer 5.5+
  • CACTUS Database (installed with ISYS) is available via LAN
  • EQU 2.0 ActiveX component
  • CACTUS MetAn Client installation

  • 200 MHz Pentium or compatible CPU
  • 64 MB RAM
  • 20 MB free hard disc space
  • CD ROM drive (min. 24x if multimedia materials are kept on CD)
  • TCP/IP LAN
  • 800x600 high color display (true color recommended)
  • 16 bit Sound card
  • Windows 98, ME or NT 4.0 SP6+ or 2000 SP1 or XP operating system
  • MS Internet Explorer 5.5+
  • CACTUS Database (installed with ISYS) is available via LAN
  • EQU 2.0 ActiveX component
  • CACTUS On-line Course installation

  • 200 MHz Pentium or compatible CPU
  • 64 MB RAM
  • 50 MB free hard disc space
  • CD ROM drive (min. 24x if multimedia materials are kept on CD)
  • TCP/IP LAN
  • 800x600 high color display (true color recommended)
  • 16 bit Sound card
  • Windows 98, ME or NT 4.0 SP6+ or 2000 SP1 or XP operating system
  • CACTUS Training Center
  • Adobe Acrobat Reader 4.0+ (if PDF ref. materials are included)
  • 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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