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IBSA

The merger between the experience of the management staff of Swiss IBSA and the technological know-how of Arti Informatiche has allowed the construction of a vertical pharma particularly focused on the management of all the "FDA" (Food & Drug Administration) requirements in the pharmaceutical industry.

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Pharmaceutical

Attachments :
Settore Pharma.pdf [6 Mb]

compliance with 21 CFR Part 11

The pharmaceutical industry is characterized by the need to standardize the information system with GMP (Good Manufacturing Standards), as well as with FDA standards ("Food and Drug Administration"). The FDA's task is to delineate the exact standards of good manufacturing that are interpreted within the single state and determined as strictly necessary, in order to ensure that production is under control.

For manufacturers of drugs or cosmetics, it is 'vital that their products and production cycles meet the ongoing ministerial standards, including compliance with 21 CFR part 11.

Ideale2010 is an application awaiting for certification from national firms of global relevance.

Quarantine management,  management of the lots compliance, organization of the issues, management of the "Audit Trail" and configuration of access to masks with incoming protection and when editing the data, are the main "requirements" that an ERP software for the pharmaceutical industry must have, to avoid the inability to ensure the company with the opportunity to participate in a "Validation Plan process.

With Ideale 2010 a pharmaceutical company can manage:

  • Safety and labeling of the production line of an item, from its raw materials to the placing on the market
  • statuses of the lots (quarantine, compliant, inspection, authorized, expired..), the total traceability
  • prints of drugs labels with a logo for each label
  • the calculation of the other ingredients and materials
  • the title percentage in bills of materials of the items
  • recipes and amendments to a bill of materials
  • editions of the publication of leaflets with log of n editions of a given leaflet over the years.  Only one of these editions is in force at a given moment and is listed among the supplier orders and sales
  • the expenditure refunds of sales representatives through a website that communicates with the management database

IBSA

The merger between the experience of the management staff of Swiss IBSA and the technological know-how of Arti Informatiche has allowed the construction of a vertical pharma particularly focused on the management of all the "FDA" (Food & Drug Administration) requirements in the pharmaceutical industry.

>>
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