Where are you now? 21 CFR Part 11 Compliant Products > Production Executive Suites > Production Suite > LibrIN
LibrIN ![21 CFR Part 11 Compliant](/imgcom/CFR-symbol.gif)
Introduction
LIBRA means perfectly balanced state. LibrIN is a perfect tool
for a multifunction weighing and measuring system with integrated formulation
management, SQC and SPC capabilities. LibrIN also provides full calibration
& maintenance support for your scales & balances.
Key Features
- 21 CFR Part 11 Compliance
- no
buts and ifs
- SQL database
- SQL database provides secure and efficient management
of all your data
- Integrated formulation management module
- LibrIN includes effective
support for managing formulation & compounding tasks
- On-line weighing & measurement
- LibrIN provides real-time
documentation for weighing & compounding
- Integrated calibration & maintenance of scales
- proper
calibration & maintenance of scales are critical quality & regulatory
criteria
- Integrated Statistical Quality Control (SQC)
- SQC provides powerful
analytical capability in making the right quality decisions.
- Integrated Statistical Process Control (SPC)
- with SPC you will be
able to monitor material & production quality & efficiency
- Batch scheduling
- in a simple, but effective way, you will be able to
schedule batch production,
- 7/24 Technical Support
- you will receive 7/24 technical &
regulatory support to make LibrIN and effective tool in your production process.
Applications
LibrIN meaningful solution for number of applications and
industries, including:
- Pharmaceutical,
- Biotechnology,
- Medical device,
- Food, and
- Chemical.
System requirements
- Intel Pentium 200 MHz or compatible processor
- 64 MB of memory
- 150 MB free hard disk space
- Windows 98, ME or NT 4.0 SP6+ or 2000 SP1 or XP operating system
- Internet Explorer 5.5 or later
- CD ROM drive
- SVGA colour monitor set to 800x600 graphical resolution with high colour
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 LibrIN 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](/imgcom/Stopsymbol1.gif)
DQ supports the functional
& quality specifications designed into LibrIN. 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 LibrIN.
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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