Greater Cambridge Area
Limited company offering professional services to the Biotechnology, Pharmaceutical and Medical Device Industries.
- Update the Computerised Systems List - Generate a Periodic Review Schedule for CSV systems - Validate an upgrade to the ThermoFisher Scientific Chromeleon Data System to v7.3.2 - Validate an upgrade to LIMHQ to v5 - Raise / QA support, Deviations, NCRs, CAPAs, CAPA Actions, Change Control - Risk Management (FMEA, Impact Assessment) - Prepare Validation Plans and associated Validation Protocols - Protocol Execution - Supplier Audits - Oversight review validation of Q-Pulse eQMS
- Pharmagraph EMS. Validation of a network upgrade to remove a single point of system failure, - eMaint. Design Qualification of the Calibration Management system, - Supplier Audits, - Q-Pulse eQMS. Validation of a substantial update to the user permissions configuration, - Q-Pulse eQMS. Upgrade from v7.1.5.1 to v7.6.1, - Validation of label printer software, - MasterControl eQMS. Validation of annual updates x2, - STARLIMS. Periodic review and initiation of routine Backup & Restore testing, - SAGE WMS. Periodic Review, - Kneat Implementation. SME for Process Validation Life-Cycle phase, - Update of Periodic Review SOP and associated templates, - SME Cleaning Validation, mentorship of new validation team member, - SME supporting collaborator medical device Software Validation.
- BMS / EMS HVAC. Validated control systems replacing end of life modules, - PLC Control Systems. Validated upgrades to PLC controllers and supervisory control modules for GMP production processes including 4 tablet presses and a spheroidising operation, - Fixed bugs and simplified an overly complicated Macro driven Excel FMEA spreadsheet application.
- GAP analysis to determine validated status of GMP production lines and associated facilities, - Process Validation compliance Audits for multiple packing lines, - Recruitment of additional validation resources, - Generation of Validation Plan to close the validation gap, - Generation of FMEA Risk assessments for each production line to direct validation activities, - Oversight of validation of the Purified Water Generator to bring qualification up to best practice, - Leadership and team development to achieve validation objectives, - Updated validation procedures and templates.