Market Solutions: Life Sciences
Increase Productivity & Reduce Waste: Integrated Quality Management, Six Sigma & Process Control
Design, development and manufacturing in a risk-based, quality-assured environment are prerequisites of regulatory approval in Life Sciences such as Pharmaceutical, Biotech, Medical Device & Blood Services. With the penalties for non-compliance ever increasing, and given the competitive nature of the global business environment, it becomes essential to reduce cost of compliance and associated resource expenditure, such as due to duplication of effort, audit preparation, and audit follow-up.The Life Sciences market is now embracing a systematic risk-based approach to regulatory compliance, thereby increasing regulators’ confidence and addressing potential product risks. Q-Pulse is a fully integrated compliance management solution that covers key regulatory functions such as Auditing, Document Control and CA/PA Management. Quality improvement and waste reduction opportunities, identified via audits, feedback from customers or process personnel, and results of process control strategies are promptly identified, prompting Corrective Actions jointly managed by key stakeholder groups. Action items from CAPA, audits and strategic business initiatives are tasked and tracked for optimal efficiency and feedback as Six Sigma process improvement projects. Approvals are seamlessly communicated as necessary throughout the stakeholder groups.