Improving Pharmacy Quality Management with Q-Pulse ‘a manufacturing perspective’

1. Improving Pharmacy Quality Management with Q-Pulse ‘a manufacturing perspective’ Shakeel Herwitker Assistant Director Of Pharmacy UKCPA ITIG Seminar - 6 October 2010

2. Identifying a need! • Quality Systems within Manufacturing • GMP Issues • Event Capture • Inspection Process Management • External inspections • Delivering on self inspection • Controlling Change • Managing Assets

3. Q-Pulse Q-Pulse is a fully integrated Quality Management Solution to help Pharmacy Departments not only achieve and maintain regulatory compliance, but also help to effectively manage, centralise and streamline all Quality processes and procedures.

4. What do we need to manage?

5. Why implement a QMS? • Enables more effective management of all areas of Quality - Historic, Present & Future. • Improves the organisation of compliance activities including, Document Control, Audit and CA/PA. • Allows clear visibility of individuals’ responsibility of all Quality Management activities

6. Why Q-Pulse? • Offers all elements required to meet regulatory requirements. • Document Control, Audit Management, CA/PA & other modules. • Pre & Post Sales Customer Service and Support Desk. • Average 50% saving on time after deploying Q-Pulse for Quality Management. • User Friendly.

7. Why Q-Pulse? • All features in a single central Solution • Empowers users to take ownership and have visibility of their Actions and Requirements • Translates “Bigger Picture” to User Level • Easier and Streamlined Management Reporting • Departmental to Trust Levels • A future proofed Solution built on your Long Term Goals • Flexibility to cope with changes in regulation

8. Setting it up. • Out of box costs! • Licenses – primary & secondary • IT infrastructure requirements. Server location and space. • Multiple site issues. • Internet access & controls. • Set up costs. Arrives empty! • Training & Implementation Costs.

12. Q-Pulse modules • Audit • CAPA • Error/Deviation/non conformance Logging • Complaints/Compliment Management • Document Control • Asset Management • People/Training • Analysis

16. Document Module Key Benefits • Document review process including change requests etc. • Only documents which are approved by authorised personnel are released. Numbering sequence & draft management. • Master list is readily available. • Review dates can be set according to accreditation requirements and email alerts sent out. • A list of persons required to read the document and “proof” that they have read the document. • Pervious versions are readily available if need be without the need for hard copies.

17. CAPA/Audit Module Key Benefits • Record of all audits including • Investigation • Remedial Action • Corrective Action • Root Cause Analysis • Preventive Action • Follow-up • Email Alerts to those responsible/escalation • Wizards for ease of recording audits and templates • Analysis of CAPA’s/Criticality assessments

19. Q-Pulse benefits • Helps manage the regulatory requirements of MHRA. • Achieve more effective control of your Pharmacy documents. • Identifies areas for improvement through analysis of audit findings. • Improves productivity and effectively manages all quality processes and procedures to ensure regulatory compliance. • Supports continuous improvement through Incident Management.

20. ‘Facilitates the delivery of a Quality Management System!’