LibrIN - FAQ

1. What is LibrIN?
2. Is LibrIN 21 CFR Part 11 compliant?
3. Can I qualify my scales & document it prior to use?
4. Can I document IQ & OQ activities in LibrIN?
5. Can I perform PQ in LibrIN?
6. What is EQUAL?
7. How does EQUAL work in LibrIN?
8. What kind of database does LibrIN use?
9. Can I enter my formulation into LibrIN?
10. Can I add inventory information into LibrIN?
11. How can I use SQC?
12. How can I use SPC?
13. Can I integrate other Opulus applications ?
14. Can I integrate different scales & balances?

1. What is LibrIN?
   LibrIN is an on-line weighing & compounding program with integrated formulation, compounding management, calibration, & scale maintenance capabilities.
2. Is LibrIN 21 CFR Part 11 compliant?
   Yes, no buts and ifs.
3. Can I qualify my scales & document it prior to use?
   Yes! LibrIN supports on-line verification of your balance prior to use.
4. Can I document IQ & OQ activities in LibrIN?
   Yes.
5. Can I perform PQ in LibrIN?
   Yes, by integrating EQUAL into LibrIN statistical models have been added to monitor the quality stability of the measuring system.
6. What is EQUAL?
   EQUAL is an application library of EQU. EQU is an Application Integration System. It is a natural language SQL, modelling, & visualization development system, that can be connected through standard protocols to databases. EQU ActiveX with application packages is called EQUAL. EQUAL can be embedded into other applications, such as LibrIN.
7. How does EQUAL work in LibrIN?
   EQUAL models are natural language SQL sentences. Each model contains one ore more sentences with embedded parameters. The parameters may be defined by the user to obtain results in the form of tables & graphs about the model. EQUAL within application environment can generate thousands of decision models.
8. What kind of database does LibrIN use?
   LibrIN uses MSSQL 7.0 database for fast and secure access. Database access can be configured during the installation/reinstallation procedure.
9. Can I enter my formulation into LibrIN?
   Yes. In addition to entering the formulations into LibrIN, various characteristics of the formulation can be also included, such as dissolution, hardness, average weights for solid dose, specific gravity and viscosity for liquids.
10. Can I add inventory information into LibrIN?
    Yes. In addition to basic material information, you can also include potency, quantity, date of release, and storage location.
11. How can I use SQC?
    Statistical Quality Control (SQC) is an important quality management tool to assure that the weighing & measuring system is in state of statistical control. LibrIN includes number of evaluation models, such as Control Charts, Pareto Diagrams, & Correlation Analysis to monitor the reliability of the scales & balances. SQC can reduce significantly both the occurrence of OOS and the time of OOS investigations.
12. How can I use SPC?
    Statistical Process Control (SPC) is an important quality management tool to assure that the process is in state of statistical control. LibrIN includes number of evaluation models for Control Charts, Pareto Diagrams, & Correlation Analysis to evaluate the quality characteristics of the process. SPC can reduce significantly both the occurrence of OOS and the time of OOS investigations.
13. Can I integrate other Opulus applications?
    Yes. For example, Epsilon can be integrated for smart process validation. Other programs are being created for full coverage of Computer Integrated Batch Processing.
14. Can I integrate different scales & balances?
    Yes. Let us know & we will do it for you at no charge.