Implementing an effective Electronic CAPA Management System

Implementing an effective Electronic CAPA
Management System

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Gael Ltd – Leaders in Quality
Thought leaders in the world of Quality,
Compliance, Control and Audit
 Founded in 1992
 100+ employees
 +600 Healthcare & Life Science
Clients
 Strong Customer Service ethos
 Deloitte Fast 500 Growth company
(25%+ growth year on year)


Today’s objective
 Regulatory requirements for CAPA
 Elements of effective CAPA
systems
 How and why your CAPA
processes should integrate with
other compliance activities
 Benefits of implementing an
electronic CAPA management
system 'v' a manual one


The Reasons
 Help Achieve an Organisation’s
Objectives
 Address Uncertainty
 Support Correct Decision
Making
 Drive Performance
Improvement


The Challenges – Staff Buy In
Under used systems
 Not user friendly
 No obvious benefit to user
 Poor communication and feedback loop

Lack of awareness
 No consistency
 Must be top down approach led by
management
 Culture shift – feed the CAPA system


The Challenges - Visibility
All control points flow through CAPA system
 Deviations / NCRs
 Audit Findings
 Equipment monitoring
 Staff Training
 Change Control
 OOS
 Complaints
 Product recalls / returns
 Adverse events
 Management Review

Managing the ripple effect across all areas is
problematic and difficult to maintain


The Challenges - Regulatory
21 CFR 820.100 Corrective and Preventive Action
 'Establish a CAPA Procedure'
 'Analyse with statistical methodology sources of quality data to identify
sources of quality programmes'

ISO 13485 8.5.2 Corrective Action
 Organisation shall take action to eliminate the cause of nonconformities to
prevent recurrence
 The corrective action shall be appropriate to the level of the effects of the
non-conformance

ISO 13485 8.5.3 Preventive Action
 Organisation shall take action to eliminate the cause of nonconformities to
prevent occurrence
 The preventive action shall be appropriate to the effects of the non-
conformance

21 CFR Part 11 Guidelines
 Electronic Signatures
 Full Audit Trails
 Intruder Lock-out
 Strong Passwords

Electronic Systems Validation
 IQ / OQ / PQ


The Challenges - Regulatory
MHRA’s top 3 QMS related deficiencies
 Incomplete or tardy recording and investigation of complaints and
incidents
 No regular review of quality indicators
 Lack of quality improvement / CAPA processes

FDA Warning Letters 2012
 CAPA subsystem cited in 81 0f 89 FDA warding letters (91%)


Common Scenarios
Paper Based Systems
 Paper based reporting forms
 Information held in silos
 Manual intervention

Internally Developed Systems
 Minimal development and support
 Hybrid systems
 Departmentalised
 Lack of regulatory Control


Possible Solution
An effective solution should provide
 Accountability
 Analytical intelligence
 Encouragement to appropriate people
 Simple event capture
 Simple reporting
 Effective notification
 Reduction in risk

How does Q-Pulse do it?


Q-Pulse: Integrated Solution


Some of our customers …


Typical Standards
 ISO 9001
 ISO 13485
 FDA’s 21 CFR Part 820
 FDA’s 21 CFR Part 11
 EU GMP Annex 11
 CPA / CAP / CLIA
 AABB / BSQR


What our Customers are saying
“Putting Q-Pulse into place has changed the way we work considerably by
providing us with a very user-friendly system that will ensure we can
continue to meet our regulatory requirements and improve our services.
Having all the information stored centrally allows easier and more efficient
access for staff, management, and enables us to demonstrate our quality
control mechanisms to external regulators”

Dr Jennifer Cauchi, Quality Manager at BMDI Cord Blood Bank

“We primarily sought out Q-Pulse to manage document control, but then
we discovered its CA/PA, Asset and Training capabilities and were hooked.”

Andrew Havens, Quality Assurance Manager, University of Utah Cell Therapy Facility


What our Customers are saying

“Internal and external inspections are critical to our activities,
and the Q-Pulse Audit module helps us manage these activities
and link any subsequent actions to the CA/PA module. Q-Pulse
makes it easier to achieve compliance with our standards and
regulations, providing us with the tools to implement simpler
methods and processes to manage quality.”
Kevin Bruce, Quality Manager at Roslin Cells, Edinburgh

“Q-Pulse gives us a centralized way of managing our QMS
documents and records, including all of our SOPs, in line
with the record-keeping requirements of the FDA”
Marilyn Jeffers, Quality Assurance Manager, Blood Bank of Alaska


Summary
 Regulatory requirements for CAPA

 Elements of effective CAPA systems

 How and why your CAPA processes should
integrate with other compliance activities

 Benefits of implementing an electronic
CAPA management system 'v' a manual
one


4 Benefits of Adopting an Integrated
Approach to CA PA Management
 Gain company-wide commitment

 Ensure competency of appropriate staff

 Integrate root cause analysis into quality
systems

 Reinforce learning
 Download from
gaelquality.com now


Implementing an effective Electronic CAPA Management System

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