Where are you now? Regulatory Basis > 21 CFR Part 11 Issues > Compliant Products > Production Executive Suites > Production Suite > LibrIN
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.
- 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
- 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.
LibrIN meaningful solution for number of applications and
- Medical device,
- Food, and
- 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
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 LibrIN. Documentary proof of DQ
- 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
- 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
- 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.