HOVIONE

Hovione is a fine chemicals company dedicated to the process development and synthesis of Active Pharmaceutical Ingredients (APIs), serving exclusively the pharmaceutical industry.

Hovione has been using MIGG software since 1992. 

Document Management Needs

Today Hovione uses DocStream to manage all of their controlled Documentation accross three continents.  Hovione deployed a centralized document repository that is accessed seamlessly using a simple web browser from their manufacturing sites in the US, Portugal and China. 

DocStream allowed for the implementation of common document repository that allows a site to re-use controlled documentation available at other sites.  This concept of document adoption contributed towards fast 'ramp up' of the Quality System of new sites and avoided costly duplication of documentation while ensuring harmonized policy accross all sites of the group when this is deemed advantageous.

Seamless web Navigation through ERP, Sales and LIMS data

Hovione uses Navstream to integrate data from various systems including SAP R3 ERP and Labware LIMS and deliveran integrated web view of manufacturing and analytical data directly to the user.  NavStream is an easy to use web application that adopts the concept brought forward by Interntet Home Banking; You don't need training nor a manual to use it! 

NavStream came to the rescue of occasional users, including management, and provided them with a tool to rapidly access valuable buried deep in hard to use ERP systems such as SAP and LIMS.  Furthermore NavStream consolidates information on the fly from the various databases to provide the user with a simple and consolidated view that reflects the process instead of having to login to the various systems and build up a mental picture from the various data sources.

Hovione also uses NavStream to provide theirs customers with secure access to analytical and manufacturing data relating to their production batches.

Configuration Management

Hovione uses ChangeStream to manage all cGMP Change Requests.  ChangeStream is an valudable tool that manages the complete lifecycle of change and includes a thread discussion system that allows users, including accross the various sites,  to discuss important items that may be influenced by the Change Request being requested.

Through the use of electonic signatures the complete lifecycle can be managed online allow change request to be expidated in a fraction of the time than with the previous system.

DocStream, ChangeStream and NavStream have been validated at Hovione according to GAMP 4 and the final validation report found the solutions to be in compliance with the requirements set forth by the FDA's 21 CFR part 11.

All three Hovione sites are regularly inspected by the US Food and Drug's Administration.