| Various Life Sciences Companies | Project Managemen/ Training | Training on Enterprise & Plant Computerised Systems Compliance for regulated Life Sciences companies. Focus of training is GAMP5 best practices & Project Management, Computer Systems Validation, and the relevant international regulations (e.g. GxP’s, ICHQ9/10, FDA 21.CFR.11, EU Annex 11). |
| Pharmaceutical Multi Plant Facility | Strategic Planning | Strategic planning (requirements consolidation, solution research and formal system appraisal, ROI based business justification, & budgetary planning) for a Manufacturing Warehouse Management System (WMS) incorporating integration to production & materials planning, manufacturing & packaging, shipping, QA & QC operations, and integrated to MES & ERP. |
Large Pharmaceutical Co. (finished solid oral dosage) | Strategic Planning & Project Management | Budgetary planning, ROI based justification, Programme planning, and full Project Management for EBRS introduction to address 4 individual plants covering bulk granule, capsule, intermediate, finished tablets, and multiple packaging lines. The EBRS is integrated to MES components, plant equipment, ERP, and LIMS for manufacturing continuity. See also our CASE STUDIES for more detail. |
Large Pharmaceutical Co. (finished solid oral dosage) | Strategic Planning, System Selection & Project Management | Planning and selection for a multi-plant Electronic Document Management System application. Included business analysis, requirements definition, tender management, solution appraisal (encompassing multiple EDMS/ECMS market leading solutions), ROI justification, and contract negotiation. Provided Project Management steering services for project execution. |
| Active Pharmaceutical Ingredient (API) Plant | Project Management | Project Management steering for a full Electronic Quality Management System implementation for Deviations and CAPA (Corrective Actions & Preventative Actions). |
Large Pharmaceutical Co. (finished solid oral dosage & API) | Project Management | Project Management (planning and execution) for an integrated Laboratory Informatics application in a multi-plant environment. Included core LIMS and ELN introduction & centralised CDS functionality, LIMS-CDS integration, instrument integration, LIMS-plant integration, Stability, Reagents Management, & automated Certificates of Analysis. |
| Irish based Pharmaceutical Co. | Strategic Planning & Project Management | Strategic Planning and Project Management steering for a full new EQMS application, including Deviations, Investigation, CAPA, and Effectiveness checking. |
| Irish based Pharmaceutical Co. | Strategic Planning | Front End Study for capacity planning solutions to address Plant to QC critical planning business challenges. Objective was to determine planning application market maturity with respect to company requirements and develop a commercial shortlist to facilitate decision support for business problem resolution. |
Large Biopharmaceutical Co. (Fill/Finish & Solid Oral Dosage) | Project Management | Project road mapping and risk review for Laboratory Information Management and Equipment Integration, within the constraints of a corporate rollout template. |
| Irish based Pharmaceutical Co. (finished product) | System Selection | Definition and Management of the selection process for a multi-plant Laboratory Informatics application across multiple LIMS market leading vendor solutions. Included requirements definition, tender management, cost analysis, and contract negotiation. |
| Irish Management Training Company | Strategic Planning | Executive training content focussed on clarifying the role of bioinformatics in Drug Discovery with the objective of simplifying technical complexities for senior management audiences. |
| Irish based Pharmaceutical Co. | Strategic Planning | Completion of an integrated informatics strategic road map to specify computerised applications and their inter-dependencies across QA, Laboratory, Plant, and Enterprise with a view to addressing ongoing business challenges. |
| Two large European based Bio/pharmaceutical Companies | Strategic Planning | Consulting re. integration of laboratory informatics applications (Laboratory Information Management Systems and Chromatography Data Systems) to form seamless laboratory information flows from automated scientific and quality data collection to information management and reporting. |