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Computerized Systems Validation
Gai Anbar, CEOMarch 2013
About Comply
Comply provides consulting services in the area of Computerized Systems Validation and IT QA
as well as development and implementation of
Generica Quality Management System, Skyline Scientific & Process Data Management
Supporting Life Science companies to meet the highest quality and operational standards
Software Solutions by Comply
• Generica Quality Management: change management, controlled documents, employee training, audits, deviations and CAPA tracking.
• Skyline: Scientific Data Management, R&D, QC and manufacturing data management and analysis.
• Mobideo Guide: Mobile workflows and validated data capture.
Value proposition
One of the most prominent differentiators between providers in the Life
Science industry is quality.
This industry is highly regulated and is regularly audited, making compliance a major risk for all operations. The industry, in turn, expects its vendors to demonstrate the same and many times higher, level of compliance.
Comply brings extensive, proven, Life-Science compliance expertise. Reducing risks. Giving our customers an edge over their competitors.
Why do we need validation ?
Vetmarket: Scope & Methodology
• Audit and Gap Analysis
• Risk analysis
• Define policies and procedures
• Complete engineering & technical files
• Infrastructure validation
• Shipping validation
• Computerized systems validation
• GDP preparation
The purpose of Validation
FDA: General Principles of Validation:
Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specification and quality attributes
General Principles of Software Validation; Final Guidance for Industry and FDA Staff (2002)
confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled
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משרד הבריאות
הוכחה סיסטמתית מתועדת -( תיקוף)=ולידציה : 135לפי תקן •כך לגבי GMPהמבוססת על ניהול סיכונים ועומדת בדרישות
.שתהליך מוגדר מוביל באופן הדיר לתוצאה הנדרשת
Regulations
• FDA 21 CFR PART 11: Electronic records; Electronic signatures (1997)
• FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff (2002)
• FDA Guidance for Industry: Part 11, Electronic Records: Electronic Signatures – Scope and Application (2003)
• FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations (2008)
• EC (including Israel): Volume 4 Annex 11: Computerized Systems (2011)
• ISPE GAMP5: A Risked based approach to Compliant GxP Computerized Systems (2008)
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Europe & UK
• UK’s MHRA in December 2013 gave notice to regulated users to begin conducting data integrity audits of their own systems and those of their suppliers from the beginning of 2014.
• The UK has also gone further by writing to the major suppliers of chromatography data system software requesting copies of the application and documentation to that the MHRA can understand how they operate and how falsification could occur.
• In March 2015, MHRA issued an updated Data Integrity Guidance containing an expansion of the expectations of data integrity governance together with a list of 19 definitions and expectations for each one.
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Vendor vs. Customer (the lab) validation
• According to the intended use
• In a specific environment
Customer Validation
• Instruments
• Software
• Generic functional testing
Vendor Testing &
Qualification
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Annex 11 – Principle
• Applies to all forms of computerized systems used as part of a GMP regulated activities
• The application should be validated; IT infrastructure should be qualified
• Where a computerized system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance.
• There should be no increase in the overall risk of the process
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Part 11: key requirements
Validation: “Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.”
Obtain records: Ability to view records for inspection
Security: Access, password, authorizations, logical and physical
Record retention : Backup & restore, DR procedures.
Audit trail: What data changed, time stamp, identity of action performer.
Training: Qualification evidence
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Part 11: electronic signatures
• An electronic signature is built from• Identification
• Authentication
• Electronic signature: • Unique and not re-used
• Contain information: name of signer, date and time, meaning (Reviewer, Approver etc.)
• Linked to their respective electronic record
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Key Principles in CS Validation
1) Life cycle approach• Implementation including validation
• Operation and change management
• Retirement
2) Risk based• Risk management throughout the life cycle
• Focuses the validation effort
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Life cycle approach
Project initiation
Requirements gathering
(URS)
Vendor assessment &
solution selection
Implementation
DRP
Change Control
Period Reviews
Continuous reviewand evaluation
Risk assessments should be performed in all the steps
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Data integrity
Data integrity is the assurance that data records are
accurate, complete, intact and maintained within
their original context, including their relationship to
other data records
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Validation and Data Integrity
• Part 11 / Annex 11 requirements
• Logical tests: dates, data length, verification of entered data
• User management: • No “general” user. • Password complexity, renewal
• Permissions, segregation of duties
• Mandatory fields
• Verification of Workflows, statuses, e-signatures
• Verification of interfaces
• Supporting procedures
• User training
Positive and
Negative tests
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The launch of this new IT system has resulted in operational
disruptions and some incorrect product deliveries.
2 December 2015
7 December 2015
arising from certain technical problems encountered following the launch of its
new IT system in August 2015. Production is expected to resume when the
Stallergenes’ IT system issues have been resolved and all observations made by
the ANSM have been satisfactorily addressed.
1 February 2016
“We are pleased with the resumption of ORALAIR®, ACTAIR® and
ALYOSTAL® Venom production. These products will be available again to our
patients as soon as possible and in a sequential manner,” said Fereydoun Firouz,
Chairman and Chief Executive Officer of Stallergenes Greer.
Stallergenes Greer continues to work with the ANSM to promptly resume
distribution of its Named Patient Products (NPP), including STALORAL®,
PHOSTAL®, and ALUSTAL®.
