Although we have broad integrated IT applications and vendor experience across the life sciences research and manufacturing supply chain, the repeatable methodologies we employ in our consulting and project management services are largely application independent.
We promote an integrated approach to road mapping the IT landscape, where best-in-class Configurable Off The Shelf (COTS) applications are seamlessly integrated to provide a continuous manufacturing supply chain, a framework for Manufacturing & Business Intelligence, a Regulatory Compliance safeguard, and ultimately an enabler for Operational Excellence.
We are experienced practitioners of GAMP (Good Automated Manufacturing Practice forum, published by the ISPE) and related industry good practice guidelines. Our repeatable project processes have evolved with changes in industry guidelines, from the first general GAMP guide (v3, 1998) to the current GAMP (v5, 2008), a Risk-Based Approach to Compliant GxP Computerised Systems. Our processes also reflect the significant overlap between GAMP and other relevant guidances including ICH Q9 (International Conference on Harmonisation, Quality Risk Management) and PIC/S PL-011 (Pharmaceutical Inspection Co-op Scheme, inspectors guide for good practice in computerised systems). Our alignment with industry good practice helps us to confidently deliver GxP projects that support compliance to regulatory requirements including (but not limited to) FDA 21 CFR Part 11 final ruling for electronic records & signatures, and Eudralex Volume 4 Annex 11 for Computerised Systems (see also our AFFILIATIONS page).
- MES = Manufacturing Execution System
- EBRS = Electronic Batch Record System
- LIMS = Labratory Information Management System
- ELN = Electronic Laboratory Notebook
- CDS = Chromatography Data System (or Network Data System)
- SCADA = Supervisory Control And Data Acquisition
- DCS = Distributed Control System
- EAM = Enterprise Asset Management
- CMS = Calibration Management System
- FMS = Facilities Management System
- ECMS = Electronic Content Management System
- EDMS = Electronic Document Management System
- EQMS = Electronic Quality Management System
- HCM = Human Capital Management (System)
- LMS = Learning Management System
- L&D = Learning & Development (System)
- PPS = Production Planning System
- Talent Mgt = Talent Management (System)
- WMS = Warehouse Management System
- MRP = Material Requirements Planning
- ERP = Enterprise Resource Planning
- Bench = lab bench-top equipment proprietary software & firmware