B.I.O. Validation® Package

The SEND Package allows you to export the data aquired by TOX-LAUNCHER and generates files in the CDISC SEND format, the format recommended by the FDA for electronic submissions.
By using the SEND Package along with each subsystem of TOX-LAUNCHER, electronic submissions to the FDA are generated very easily and very rapidly.

We are offering various validation support packages!
You can implement the best solution to meet your GLP business requirements efficiently.
During the operating phase, you can enhance your business smoothly to make the most of the characteristics of TOX-LAUNCHER.

♦Business suitable-package
 ・TOX-LAUNCHER is composed of validated modules like LEGOR building blocks
   for the GLP business.
♦Total-Package
 ・This package supports total validation activity from CSV policy to SOP.
 ・Cover the most of GLP business area with the TOX-LAUNCHER characteristics.
 ・Engage a dramatical reduction of validation resources in long term operation.

B.I.O


The fundamental concept of CSV which is affiliated with GAMP and another guidelines is the safety of patients.
We are sure that the requirements of regulatory validation for a patient goes into the user's activity for a patient and/or consumer.
TOX-LAUNCHER has been a pioneer by including the automated testing functions since 1999.
Implementing TOX-LAUNCHER not only helps in performing CSV efficiently, but also enhances the user requirements through the system life cycle.
Labor and validation activity therefore become more efficient through research environment change, system updates and improvement of business.

H&T provides documents and operations that are required for CSV.
By selecting TOX-LAUNCHER, modules may fit easily into the customer's own CSV policy or regulations, allowing performance of the CSV activity more efficiently.

【Project Package ingredients】
 ♠Validation planning
 ♠User Requirement Specification (URS)
 ♠Functional Specification (FS)
 ♠Architecture Design Specification (ADS)
 ♠Software Design Specification (SDS)
 ♠Planned Installation Qualification (IQ)
       Preparing IQ Scripts
       Conducting IQ (including hardware and software)
 ♠Planned Operational Qualification (OQ)
       Preparing OQ Scripts
       Conducting OQ
 ♠Planned Performance Qualification (PQ)
       Supporting to create PQ Scripts
       Supporting to conduct PQ
 ♠Reporting test evidences
 ♠Reporting validation results
*We are available to develop the CSV policy for each customer.

What is GAMP?
GAMP stands for Good Automated Manufacturing Practice, which was established as a technical sub-committee of the International Society for Pharmaceutical Engineering (ISPE) to promote the understanding of the regulation and use of automated systems.
GAMP guideline (Guide for Validation of Automated Systems) is implemented widely as its liability for computer system validation.

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