ANALIS GMP Production module, a GAMP 5 qualifiable module which ensures a full part 11 compliance.

Production quality constraints are necessary for clinical batches but can also slow down R&D by adding unnecessary management complexity to a research process.

 

ANALIS has been designed around a very open and flexible R&D module which evolves rapidly as technology changes.
Once the GMP module is installed, all data are gathered and protected in a SQL database. Some R&D functioning modes are incompatible with GMP production and are disabled when you are running production batches. User management allows you to control production with the necessary rigor while leaving flexibility to the R&D users.

 

The operator can create and recall recipes, use weight regulation and good/bad tablet sorting to create tablets within tight specifications, edit reports with all parameters of production. The production can even be made in several batches or run consolidated if necessary.

 

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Analis Advanced 1Video Multilayer

ANALIS a suite of software solution for R&D and GMP production. Available on Medelpharm machine and some others brands.

GAMP 5 qualification

ANALIS is a standard "off-the-shelf" software whose parameters are configured for customer usage but not specifically designed for a customer. It is classified as Category 3 according to GAMP 5 software categories.

Analis GMP software module ensures risk limitation when when a customer performs a Quality Risk Assessment approach, whilst maintain machine ease of use and flexibility as much as possible.