Software Integration and Qualification of an MS SharePoint based knowledge management infrastructure for a large Pharmaceutical Manufacturing Facility. The system provides web based workflow, collaboration features and an electronic repository for electronic documents / files for various departments within the facility. This includes equipment/hardware/software manuals, validation documentation, CAD drawings, PLC programs, packaging documentation, batch records, stability reports, etc.. The solution incorporated ValiMation’s Application Implementation Methodology (AIM) for rapid deployment.
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A sterile manufacturing facility was looking for consulting help to assist their Information Systems (IS) department to support the validation / compliance department. The consulting assistance was needed for the following reasons...
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A particular sterile manufacturing company was using BPCS as an ERP system for over 10 years. However, the system was not validated and the company was using manual processes and manual documentation to meet many compliance needs. They were mandated to validate their ERP system by the EMEA....
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