“We are living in an era of ‘dumb’ content,” says consultant Nagesh Nama, President of ValiMation, Inc., and who spoke at DIA 2010 in Washington, DC. [Note: Nama's talk preceded that by Novartis' Jim McElroy, featured in yesterday's post on "The Paperless Validation
Lifecycle."].
Problem Definition
A large pharmaceutical conglomerate was establishing a brand new, state of the art sterile manufacturing plant. The facility design had to comply with the requirements of the United States Food and Drug Administration (FDA), the Japanese Ministry of Health and Welfare (JMHW) and the European Agency for the Evaluation of Medical Products (EMEA). However, the effort had the following major stumbling blocks....
Read MoreProblem Definition
A GLP laboratory within a large research establishment comprised of several laboratory systems that are used in GLP studies. This project involved development of a master plan and the compliance infrastructure for the entire GLP organization. It also involved development and implementation of life cycle deliverables for several laboratory systems. The validation effort had the following major stumbling blocks.....
Read MoreProblem Definition
A company, with several facilities across multiple continents, was looking to qualify their network infrastructure. The qualification effort was underway for over six months prior to ValiMation’s involvement, and the project going nowhere fast. The qualification effort had the following stumbling blocks....
Read MoreSoftware 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.
Read MoreProblem Definition
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...
Read MoreProblem Definition
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....
Read More