computerised systems in pharmaceuticals
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Date Insert onMaster Slide
Slide 1
Computerised Systems
Alfred HuntInspector
Wholesale Distribution Information Day, 28th September 2012
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Index
Slide 228th September 2012
What is a computerised system
Updates to EU GDPs
Expectations
Case studies
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What is a Computerised System
Slide 428th September 2012
GAMP 5
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Slide 5
Computerised Systems withinWholesaling
Systems which may impact on productquality
Provide safety or quality data
Impact operational reliability
Maintain regulated data
A few examples
Inventory Management Systems
Sales and Invoicing Systems Temperature Monitoring Systems
Document Management Systems
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Question
In the event of a recall how would you identify who yousupplied the affected product to?
a) By manually checking through all paper invoices
b) By manually checking a goods-out logbook
c) By manually checking through electronic records
d) By running a product search on an electronic inventory /invoicing system?
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Why New Requirements?
Patient safety
Product quality
Data integrity Where a computerised system replaces a
manual operation, there should be noresultant decrease in product quality orquality assurance
Did we build the right system & did webuild it correctly?
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Revised EU Guideline on GDP (Draft)
Section 3.19
Before a computerised system is brought into use, itshould be demonstrated through appropriatevalidation or verification studies, that the system is
capable of achieving the desired results accurately,consistently and reproducibly.
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Section 3.20Written detailed description
Diagrams
Kept up-to-date
Principles Objectives
Security Measures
System scope
Main features
How the system is used
How the system interacts with other systems
Revised EU Guideline on GDP (Draft)
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Section 3.21
Data should only be entered or amended by personsauthorised to do so
Revised EU Guideline on GDP (Draft)
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Slide 11
Section 3.22
Data should be secured by physical or electronicmeans and protected against accidental or un-authorised modifications. Stored data should be
checked periodically for accessibility. Data should beprotected by backing up at regular intervals. Back updata should be retained for a period stated in nationallegislation but at least 5 years at a separate andsecure location.
Revised EU Guideline on GDP (Draft)
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Section 3.23
Procedures to be followed if the system fails or breaksdown should be defined. This should include systemsfor the restoration of data.
Slide 12
Revised EU Guideline on GDP (Draft)
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Configurable
Non - Configurable
What to Do???
Slide 13
Risk of Failure / Defects
Standard Software
& Hardware
Custom Software
& Hardware
Greater complexity
Less user experience
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Level of Validation
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Life Cycle Approach
1. Concept(User Requirement Specification - URS)
2. Project(Functional Specification, Design Specification)
3. Operation
(Ongoing maintenance systems)4. Retirement
GAMP 5
Supplier InvolvementIs the system being validated the same as the proposedsystem?
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User Requirement Specification
Slide 15
A document that specifies the requirements for acomputerised system what it should do
Should be commensurate with level of risk,complexity and novelty of system
Should be detailed enough to allow for subsequent
verification of system requirements
May include operational requirements , functionalrequirements , data requirements, technicalrequirements, interface requirements, performancerequirements, security requirements, maintenance
requirements, retirement requirements For commercially available systems - may be part
of purchasing document
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Software Validation
Slide 16
Category Validation Approach
1
Infrastructure Software
Record version (include service pack).
Verify Correct Installation
3
Non - Configured
URS
Record version and verify installation
Risk based tests against requirements
Procedures put in place for maintaining compliance
Consider auditing supplier for critical and complex applications
4
Configured
As above, plus
Life cycle approach
Supplier questionnaireAdequate QMS
Risk based tests against requirements in a test environmentRisk 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 M 4
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Hardware Validation
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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Load Reviews
Ensuring that your system can cope with alleventualities
Minimum level through to greater than expectedload
Repeat if new area / site added
Growth modelling
Number of users number of transactions memory capabilities
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Suppliers
Provide / Install / Configure / Integrate / Validate /Maintain / Modify / Retain
Suitability?
Competence?
Technical Agreements
Audit
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Case Study 1
A wholesaler uses an off-the-shelf software packagefor inventory management and accounting purposes.The system was installed on a standard networked ITsystem. All wholesaling transactions are processedusing the system and it is used as their primarymethod of traceability.
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Step 1
Determine category of system
Software Category 3 (Non-configurable system)
Hardware Category 1
Step 2
Determine approach to be taken (may include)
Functionality versus URS
Record version of software/hardware, verify correct installation
Allowable users
Verify data entry capability (product, code, quantity, location)
Verify processes (orders, picking, FEFO, returns)Verify data is retrievable and accurate
Run systems side-by-side if upgrading
Training, Procedures etc
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Case Study 1
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Case Study 2
A wholesaler installs a temperature monitoringsystem into their warehouse. The system consists ofwireless probes which send a signal to a relay boxwhich in turn sends a signal to a receiving unit linkedto a PC. The data is uploaded via broadband to thesystem suppliers hosting site. In order to access the
data the wholesaler must log in to the supplierswebsite.
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Step 1
Determine category of system
Software - Category 4 (Configurable system)
Hardware Category 2
Step 2
Determine approach to be taken (may include)
URS / Functional Specification (may be combined)
Operation and performance of system versus URS & FS
SLA with supplier, consider audit
Record version of software, hardware details
Verify operation of system under load conditions
User access levels
Ensure data storage is secureVerify data is retrievable and accurate
Verify hardware is compatible and functioning (commission andcalibrate)
Run systems side-by-side if upgrading
Training, Procedures etc
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Case Study 2
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Other Requirements
User procedures
Training
Software package documentation
Hardware package documentation Passwords
Routinely change (Different cases,numbers, characters)
Not to be shared!
Usernames specific for person & not
ambiguous
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Change Management
Changes to a part of the system pose arisk due to interdependencies
Does the process owner know if suppliermakes a change? (SLA)
Version controlled Record, assess, approve and document
changes
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Retention
5 years (Depending on products!) Regulatory duty
Preserve content and meaning
Back-ups (archiving / long term retention) validation of data and media integrity(number of uses etc)
Restoration (time, routine verification)
Separate and secure location
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Ongoing Maintenance
Ongoing monitoring of systemsperformance
Error Logs
Operator training
Change control
Maintenance of user manuals / SOPs
Updates to system
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Recovery after failure
Restoring system to correct state Log file of transaction records
Incomplete transactions
Protocols and procedures for testing
Manual data entry
Outage investigation
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Retrospective Validation
Legacy systems / Reclassification Focus attention on those computerised
systems with most impact on patientsafety, product quality, and data integrity
Risk assessments History of use
Maintenance
Error logs
Validation plan / Gap assessment
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Risk Management
Useful for retrospective validation Assess risks Apply controls
Linked to the protection of the patient
Level of effort, formality, documentationshould be commensurate with the level ofrisk
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Databases
Databases and repositories should also bevalidated
Database integrity size?
Compatibility with other systems
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Commercial Spreadsheet Applications
Highly configurable
Difficult to validate
Audit trails
Changes
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Outsourced Services
E.g. Temperature monitoring Security of data
Control of data / ownership
Access
Service Level Agreements
Disclaimers
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Considerations
Patient safety is priority Audit trail
Ease of validation
Electronic signatures
Support from supplier
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Further Guidance!
Slide 35
PIC/S Good Practice for Computerised Systems in
regulated GXP Environments www.picscheme.org
Eudralex Volume 4 GMP Guide Annex 11:Computerised Systems
GAMP 5 - Good Automated Manufacturing Practice
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Thank you
alfred.hunt@imb.ie
compliance@imb.iewww.imb.ie
01-6764971
mailto:alfred.hunt@imb.iemailto:compliance@imb.iehttp://www.imb.ie/http://www.imb.ie/mailto:compliance@imb.iemailto:alfred.hunt@imb.iemailto:alfred.hunt@imb.iemailto:alfred.hunt@imb.ie
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