Where are you now? 21 CFR Part 11 Compliant Products > Competency Training (CACTUS) > Enterprise Edition
CACTUS Enterprise Edition (CEE) 
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. 
DQ supports the functional
& quality specifications designed into CACTUS. Documentary proof of DQ
compliance includes:
- Software Validation Plan,
- Software Validation Summary,
- 21 CFR Part 11 Validation Summary,
- Measurement Performance Design Summary, and
- Measurement Compliance Summary
IQ (Installation Qualification) - IQ supports the
requirement for proper installation and acceptance qualification for
CACTUS. Documentary proof of IQ compliance includes:
- Receipt & acceptance checklist,
- Physical & electrical compliance checklist,
- Environmental compliance checklist,
- Training compliance checklist, and
- Final IQ Summary
OQ (Operational Qualification) - OQ supports the
specification compliant functioning of the system. Documentary proof of OQ
compliance includes:
- 21 CFR Part 11 operational specification checklist,
- Software operational specification checklist,
- Instrument interface operational specification checklist,
- Instrument operational specification checklist, and
- Final OQ Summary
PQ (Performance Qualification) - PQ supports quality
evaluation & quality compliance management of the system. PQ compliance
models include:
- 21 CFR Part 11 compliance models,
- SQC models for instrument qualification review,
- SQC models for method qualification review,
- SQC models for vendor qualification review, and
- SQC models for OOS investigations
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