Effectively executed process validation is vital to execution of compliant and efficient manufacturing practices. Our Biomedicine team is committed to helping you understand the basis of design for the process and its connection to product quality and output. Biomedicine provides full life cycle process validation, from process design through control strategy development, qualification, and continued/ongoing process execution. The approach ties all aspects of start-up of a facility, Upstream Development, Downstream Manufacturing, and packaging and shipping.

Effectively executed equipment validation by executing installation qualification (IQ) Operation qualification (OQ) and performance qualification (PQ) for biopharma equipment. Our Biomedicine team is committed to helping you understand the basis of design for the equipment and its connection to product quality and with development specs. Equipment will be qualified and released based on the process development specs. Equipment will be calibrated to the needs of the process. Biomedicine provides full lifecycle equipment validation, equipment enrollment and equipment maintenance recommendations throughout its life cycle. The equipment lifecycle ties all aspects of start-up of a facility from commissioning to Downstream Manufacturing, and packaging and shipping qualification.

Generating and executing end to end validation on the following systems: Regulatory Asset Manager (BMRAM). Environmental Monitoring. Laboratory Information Management (LIMS). Manufacturing Execution System (MES). Software for the management of business process (SAP). Digital Quality Management system (Trackwise).

Validation Plan. Generate Protocols (Across all systems and equipment). Generate SOP, Work procedures, Forms, Templates, Documentations, etc. URS/FS/DS. Risk Assessments. Installation and Operational Qualifications. Performance Qualifications. Data Migration Plan and Testing. Data Management.