Technology Projects

2006 - Ongoing: USA: Factorytalk's Manufacturing Execution System (MES) team support the implementation of a MES roll-out project for 5 Biotech API production facilities across North America and Porto Rico. Responsibilities include; Key user training, functional requirements development, solution design, system installation, configuration/parameterization, system testing and validation, and go-live support. The project scope covers all functionalities for Production Inventory Management, Manual Weighing/Dispensing, Quality Management and the integration to a regional ERP system. Later in 2007, Factorytalk support for all five sites to change-over the interface to a new ERP system (SAP) and support the extension of the solution to include Material Tracking through all production phases. For more information read on here.

2007 - 2008: Berkeley, USA: Factorytalk support the implementation of a full scope Manufacturing Execution System for a critical Biotech API facility to ensure complete system management across the areas of: Production Inventory Management, Master Batch Recording, Electronic Batch Recording, Manual Weighing/Dispensing, Material Tracking, Quality Management and integration to SAP ERP system and Distributed Control Systems (DCS). Responsibilities of the Factorytalk team includes; extensive key and end user training, User Requirements GAP analysis, solution design, system installation, configuration/parameterization, system testing and validation and go-live support. For more information read on here.

2007: Singapore: Factorytalk provide complete onsite support services for a Manufacturing Execution System to manage operations at a leading pharmaceutical stopper-enclosure production facility. The following areas are covered by the solution: Warehousing Control and Inventory Management, Weighing/Dispensing and Material Tracking and integration to the global SAP ERP system. For more information read on here.

2007 - Ongoing: Singapore: Factorytalk support the implementation of Manufacturing Execution System for an advanced Oral Sold Dosage production facility with functionality for Production Inventory Management, Master Batch Recording, Electronic Batch Recording, Manual and Automated Weighing/Dispensing, Material Tracking, Quality Management and integration to SAP ERP system and Shop Floor Control systems. Responsibilities include; system installation, configuration/parameterization, system testing and validation. All process equipments at the facility are completely integrated to the MES and data historian using OPC communications and Factorytalk continue the close support for the facility by providing both 24x7x365 first and second line technical support and ad-hoc MES services for this best in class facility. For more information read on here.

2008 - 2009: Vevey, Switzerland: Factorytalk's Manufacturing Execution System (MES) team provides complete onsite support services for a full scope MES implementation for a critical Biotech API production facility with the following functional scope: Production Inventory Management, Master Batch Recording, Electronic Batch Recording, Manual Weighing/Dispensing, Material Tracking, Quality Management and ontegration to Oracle ERP system, LIMS and Distributed Control Systems (DCS). Responsibilities of the Factorytalk team include; extensive key and end user training, system installation, configuration/parameterization, system testing and validation and go-live support. For more information read on here.

2009 - Ongoing: India and China: Factorytalk provide complete turnkey onsite services to support the first Manufacturing Execution System for the Pharmaceutical industry in India and China. The first Solid Dosage production facility at Bangalore, India was complete in 2009 with the functional scope of: Production Inventory Management, Manual Weighing/Dispensing and the integration to a regional SAP ERP system. Following the successful deployment the solution was rolled-out to a facility in Wuxi, China also supported completely by Factorytalk's MES team. Responsibilities include; extensive key and end user training, User Requirements GAP analysis, solution design, system installation, configuration/parameterization, system testing, complete validation support for the customer and go-live support. Factorytalk continue the close support for the facilities by providing 24x7x365 first and second line technical support for these regional manufacturing sites for a top 5 multinational pharma company. For more information read on here.

2009 - 2010: Boston, USA: Factorytalk's MES team support the implementation of a full scope Manufacturing Execution System implementation at a leading Biotech API production facility with the functional scope of Production Inventory Management, Master Batch Recording, Electronic Batch Recording, Manual Weighing/Dispensing, Material Tracking, Quality Management and the integration to MFG Pro ERP system and Distributed Control Systems (DCS). Responsibilities include; extensive key and end user training, User Requirements GAP analysis, solution design, system installation, configuration/parameterization, system testing and validation and go-live support. For more information read on here.

Compliance Projects

Insights into GAMP 5- A training delivered for the Chinese pharmaceutical industry

March 31^st, 2010: Shanghai, P.R. China:China is among the strongest growing pharmaceutical markets worldwide, yet Manufacturing Execution Systems (MES) are still unknown territory for many local manufacturers.. Read on here.

Spreadsheet validation - International inspections require higher standards, Inspectors may focus on spreadsheet tools

April - March, 2010: Bangkok, Thailand: Factorytalk were asked to help a local company expecting an International inspection (TGA). Our compliance consultants performed a validation assignment for spreadsheets programs used to calculate the potency of the final sterile vaccine.. Read on here.

Train The Trainer Program: ASEAN harmonization demands higher standards

December 2009 - June 2010: Bangkok, Thailand: The Thai Government as a member of the Association of South East Asian Nations (ASEAN) is committed to establishing the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) common GMP standard as part of the ASEAN harmonization efforts.. Read on here.