Improving Pharmacy Quality Management with Q-Pulse

‘a manufacturing perspective’

Shakeel HerwitkerAssistant Director Of Pharmacy

UKCPA ITIG Seminar - 6 October 2010

• Quality Systems within Manufacturing– GMP Issues– Event Capture

• Inspection Process Management– External inspections

• Delivering on self inspection– Controlling Change

• Managing Assets

Identifying a need!

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.

What do we need to manage?

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

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.

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

• 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.

Setting it up.

Calibration Maintenance Safety

Asset Error External Audit Internal Audit Supplier Audit

Audits Product Quality Review

External Internal Customer Complaint

Supplier Complaint Complaints

Environmental Exceptions Documentation Exceptions Production Process Exceptions Dispatching, Supply & Sales Exceptions

Deviation Reports

Error Report Exceptions

Source

Facilities Equipment Clothing & Consumables Disinfectation/Sanitisation Solutions

Cleaning & Sanitisation

Post Production Issues Preparation/Manufacturing Issues Pre-production Issues

Deviation/Exception Reporting At release stage Clinical area during/after administration Clinical area prior to administration During labelling Final check prior to release Operator preparation check Other Pre-preparation check

Error Reporting

Facility Broth Transfer Validation Operators Monitoring

Process

Q-Pulse modules• Audit• CAPA

– Error/Deviation/non conformance Logging– Complaints/Compliment Management

• Document Control• Asset Management• People/Training• Analysis

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.

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

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.

‘Facilitates the delivery of a

Quality Management System!’