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Computer System
Validation:- HPRA
Expectations
Wholesale Distribution Conference
11th November 2014
Alfred Hunt, Inspector
What is validation
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“Action of proving that any procedure, process,equipment, material, activity or system actually leadsto the expected results”
1. Did we pick the correct software/hardware?
2. Was it installed correctly?
3. Do we have a working system?
4. Is the system still working?
5. Is it compliant with GDP/Regulations?
6. Is it fit for the intended use?
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•Background to CSV
•Basic GDP requirements relating to CS
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PIC/S – Good Practices for Computerised Systems in Regulated ‘GxP’ Environments (PI 011)
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Category Validation Approach
1
Infrastructure Software
Record version (include service pack).
Verify Correct Installation
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Non – Configured
User Requirements Specification
Record version (and configuration of environment) and verify
installation
Risk based tests against requirements
Procedures put in place for maintaining compliance
Consider auditing supplier for critical and complex applications
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Configured
As above, plus…
Life cycle approach (FS/DS)
Supplier questionnaire – Adequate QMS
Risk based tests against requirements in a test environment
Risk based tests against requirements within the business process
5
Custom
As above, plus…
Full life cycle documentation
Design and source code review GAMP 5 Appendix M4
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A document which specifies the
system requirements
A document which defines the
system to meet the user’s needs
described in the URS
A document provides a detailed
technical expansion of the FS
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Hardware Validation
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• Hardware Category 1 - Standard Hardware
– Installation and connection
– Record model, version number, serial number
– Change Control
• Hardware Category 2 - Custom Built Hardware
– As above plus..
– Design Specification and Acceptance Testing
– Verification of compatibility of interconnected hardware
– Supplier audit
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Validation Plan
• User Requirement Specification
• Functional & Configuration Specification (separate or together)
• Testing
• SOPs / Manuals / Drawings / Vendor Documentation
• Change Control
• Revalidation?
• System withdrawal, data migration
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– Life Cycle
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Warehouse Management System
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A warehouse management system (WMS)
controls the movement and storage of
materials within a warehouse and processes
the associated transactions, including
shipping, receiving, put-away and picking.
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Validation Plan
• User Requirement Specification
• Functional & Configuration Specification (separate or together)
• Testing
• SOPs / Manuals / Drawings / Vendor Documentation
• Change Control
• Revalidation?
• System withdrawal, data migration
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– Life Cycle
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Identify:
1. What the system does – understand it. Involve
the supplier, map it
2. How the system works (Hardware & Software)?
3. What are the critical pieces of equipment?
4. How is data maintained, secured, retrieved?
5. What are the future expectations, challenges?
6. What controls are in place to ensure compliance?
7. SOPs, manuals, drawings
8. Maintenance, calibration, training
First Steps
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1. Describe the entire system (Use vendor info)
Server, workstations, RF scanners, forklift terminals, printers, back-up & archival storage...
2. What are the system requirements
Manage stock & record transactions...
3. Testing of requirements, functions, configuration
• Define the tests which you will perform
• Perform tests
4. Report
• Results of validation exercise
• Deviations & resolution
• Further actions
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Testing Stage - Protocol
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Some key (GDP) actions of WMS
• Traceability of product (supplied / received)
• Batch number tracking
• Picking correct product
• FEFO
• Quarantine
• Approved customers for category
• Alarms / error messages
• Returns
• Archiving
• Authorised users (and number of)
• Audit trail (key actions)
• Data Transfer between systems
• Recovery following power failure
• Recovery following system failure
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Non-exhaustive list
Know your own system /requirements
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Action FEFO
(First Expired First Out)
Risk Expired / short dated product dispatched
Control WMS configured to pick all stock based on FEFO
Test 1) Ensure FEFO is assigned in configuration options
2) In test environment enter various expiry dates and
verify picked as per FEFO
3) Enter a returned product back into inventory &
ensure picked by FEFO
Expected
Result
All pick lists assign products based on FEFO
Actual Result 1)&2) – FEFO
3) Not FEFO [Reference Deviation #1]
Initial/ Date AH 11/11/14
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Dev’n
No.
Description Action Result
1 Returned products ,
once placed back
into inventory are
not picked based
on FEFO but on
FIFO basis
Contact system supplier
& request returned
products to be
assigned on FEFO basis
Supplier has verified
that configuration for
returned products has
altered so that picked
(returned) products are
based on FEFO as per
non-returned products
11th November 2014
HPRA Expectations
• CS are maintained in compliance with 3.3.1 of GDP
Guidelines
• Know both your requirements and GDP
requirements and verify that they have been met
• Validation documentation available for review for
entire system (incl. data storage and retrieval)
• Systems revalidated where required (changes to
system or processes)
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