Computerized Systems Validation. Gai Anbar, CEO March 2013

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1 Computerized Systems Validation Gai Anbar, CEO March 2013

2 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

3 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.

4 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.

5 Why do we need validation?

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7 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

8 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 8

9 משרד הבריאות לפי תקן 135: ולידציה )=תיקוף( - הוכחה סיסטמתית מתועדת המבוססת על ניהול סיכונים ועומדת בדרישות GMP לגבי כך שתהליך מוגדר מוביל באופן הדיר לתוצאה הנדרשת.

10 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) 10

11 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 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. 11

12 Vendor vs. Customer (the lab) validation Customer Validation According to the intended use In a specific environment Vendor Testing & Qualification Instruments Software Generic functional testing 12

13 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 13

14 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 14

15 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 15

16 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 16

17 Life cycle approach Project initiation Vendor assessment & solution selection DRP Period Reviews Requirement s gathering (URS) Implementation Change Control Risk assessments should be performed in all the steps Continuous review and evaluation 17

18 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 18

19 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 Positive and Permissions, segregation of duties Negative tests Mandatory fields Verification of Workflows, statuses, e-signatures Verification of interfaces Supporting procedures User training 19

20 2 December 2015 The launch of this new IT system has resulted in operational disruptions and some incorrect product deliveries. 7 December 2015 arising from certain technical problems encountered following the launch of its new IT system in August 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.

21 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.

22 Thank You