LibrIN

• Introduction
• Key Features
• Applications
• System requirements
• DQ-IQ-OQ-PQ and 21 CFR part 11
• What´s in the box?
• FAQ
• Installation guide for LibrIN
• How can I purchase 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 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.

DQ supports the functional & quality specifications designed into LibrIN. 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 LibrIN. 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.