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Senior Consultant
ABB Life Sciences
Advanced Computer Effective GAP analysis
Systems Validation as a Tool for compliance
17-18th Nov 2003 How to fit GAP analysis into
London,UK compliance initiatives
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The aim of the talk
Gap Gap
Communication Management
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Stages in the Gap Analysis process
Assessment
Provide information about the gap
Communication
Evaluate different solutions and decide between them
Carry out further investigation to arrive at a decision
Involve all relevant competencies in decision making
Estimate resources, timing and costs
Management
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Company procedures
Mandatory training requirements
gap gap
Industry best practice
(e.g.GAMP, IEEE, ASTM)
Assessment Techniques: The Checklist
Narrow scope
Multi-disciplinary input required
Discussion required
Goal is Assessment and Communication
How will you communicate the gap?
Share a written summary of findings
Give a presentation of findings
To the stakeholders
To management
Good practice suggests…
Include recommendations for gap management
Facilitate meetings with stakeholders to discuss options
Evaluate which options are best for the business
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Coaching
Deliverables
M01 Current Organogram exists, and 211.22 58.35 11.100a 1D CSV5 7.5.1
indicates independence of QA Function
Compliance
Requirement
No Reference Compliance Finding
[F01] M02 Department X has developed an excellent policy statement and supporting set of corporate
CSV Guidelines. In many ways these represent current best practice. For example:
· they are clear and easy to understand; they use a simple framework to cover a broad
range of application;
· they address all the major computer systems compliance aspects of current drug
development and manufacturing legislation;
· they have a strong core of 'risk management' reflecting both GAMP and the FDA's August
2002 announcement on the future of the GMPs.
[F02] M02 The Corporate CSV Policy and Guidelines have a fairly general definition of their scope of
application. In practice, the definition of a 'computerised system' is a little more vague, and it is
possible that inconsistencies in the application of CSV Policy across Department X may arise.
[F03] M07 During the 2001 redraft, the process for review, roll-out and staff training for the corporate CSV
Policy, Guidelines and Example SOPs was inconsistent across the three Department X sites,
resulting in inconsistent awareness of and commitment to these corporate practices.
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[F04] M01 While the Electronic Records and Electronic Signatures guideline provides a good overview of
the responsibilities required to comply with 21CFR11, the identified responsibilities are not
complete. For example:
Nobody identified as responsible for monitoring security breaches (Open systems)
Summary of Gaps across three sites
Management Gap 1
Compliance
Planning
Development
Lifecycle
Operational
Lifecycle
Technical
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Controls
Compliance
Gap 3
Planning
Development
Lifecycle
Operational
Lifecycle
Technical
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Controls
Compliance
Gap 3
Planning
Development
Lifecycle
Operational
Lifecycle
Technical
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Gap 4
Controls
Compliance
Gap 3
Planning
Development
Gap 5
Lifecycle
Operational
Lifecycle
Technical
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Gap 4
Controls
GAP Communication
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Recognise strengths
Present GAPS in spirit of
constructive criticism
GAP Analysis in the IT Environment
Dedicated Satellite to
Central IT Outsourced
Stand-alone Central IT
IT Support Services
Simple Complex
solutions
Quick
Overwhelmed by actions
Investigation of solutions
postponed No business assessment
21 CFR Part 11 Gap Analysis
slower
Immediate assignment of
actions
Immediate cost/benefit
evaluation
Good practice for Gap Management
Appoint person responsible for monitoring progress and
documenting closure of actions
Assign responsibility for finding a solution an appropriately qualified
person
Ensure all stakeholders are involved
Agree deadlines
Consider a mix of short term and long term solutions
Use risk assessment and cost benefit analysis to make decisions
Make sure you take timely steps to secure finance
Provision from current budget
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CAPEX spend
Special funding
Impractical corrective actions
Before an inspection
Assess gaps and formulate a plan for remediation
If requested present the plan during the inspection
Ensure actions are completed
Ensure time lines are met
If you receive a
FDA-483 Observation
Warning Letter
platform
Authorisation Change IT Team
of users control
Administration
of users
Revalidation
Application Software
Specialist configuration
My personal opinion
Please contact……
Dr. Jennifer Methfessel
ABB Ltd
Belasis Hall Technology Park
Billingham
Cleveland, TS23 4YS
UK
Tel: +44 (0)1642 372321
Fax: +44 (0)1642 372166
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