Computer System Validation Basics

1 1925 West Field Court, Suite 125, Lake Forest, IL 60045 Validation Center | +1(847) System Validation BasicsBy Praxis Life SciencesReproduction or re transmission in any form or by any means, electronic or mechanicalwithout prior written permission from Praxis is prohibited. 2015 Praxis Life Sciences. All rights Center Life Sciences | West Field Court, Suite 125, Lake Forest, IL 60045 | +1 (847) 295 71601 Computer System Validation Basics Copyright 2015 by Praxis Life Sciences. All rights reserved. No part of these materials may be reproduced or transmitted in any form without the written permission of PraxisYour Praxis FacilitatorValidation Center 2015 Praxis Life Sciences 2 Debra Bartel, MBA, CQA, PMP Principal, Praxis Life Sciences 25+ years experience specializing in software quality assurance, Validation and regulatory compliance, Information Systems project management, and process design.

2 Prior to joining Praxis, held management positions in the pharmaceutical industry in both Quality Assurance and Information Systems organizations Active member of American Society for Quality (ASQ), Northeastern Illinois Section, Software DivisionReproduction or re transmission in any form or by any means, electronic or mechanicalwithout prior written permission from Praxis is prohibited. 2015 Praxis Life Sciences. All rights Center Life Sciences | West Field Court, Suite 125, Lake Forest, IL 60045 | +1 (847) 295 71602 How We HelpValidation Center 2015 Praxis Life Sciences 3 Follow us!

3 Target AudienceValidation Center 2015 Praxis Life Sciences 4 Pharmaceutical & Biologics Medical Device Clinical Studies Blood ProductsIndustries Operating in the US Selling to the US MarketRegions IT Personnel and Managers Quality Personnel and Managers Auditors and Audit ManagersPersonnelReproduction or re transmission in any form or by any means, electronic or mechanicalwithout prior written permission from Praxis is prohibited. 2015 Praxis Life Sciences. All rights Center Life Sciences | West Field Court, Suite 125, Lake Forest, IL 60045 | +1 (847) 295 71603 Webinar OutlineValidation Center 2015 Praxis Life Sciences 5 CSV Regulatory Requirements1 CSV Purpose & Benefits2 CSV Methodology3 CSV Scope4 CSV Failure Consequences5 CSV Program Implementation6 CSV Regulatory RequirementsPart 1 Validation Center 6 Reproduction or re transmission in any form or by any means, electronic or mechanicalwithout prior written permission from Praxis is prohibited.

4 2015 Praxis Life Sciences. All rights Center Life Sciences | West Field Court, Suite 125, Lake Forest, IL 60045 | +1 (847) 295 71604 CSV Regulatory RequirementsValidation Center 7 Computer System Validation is require for companies that ..ActivitiesDesignDevelopConduct clinical trialsManufacturePackageLabelStoreDistri buteInstallServiceProductsPharmaceutical sBiologicalsMedical DevicesBlood and Blood ComponentsHuman Cell and Tissue Products 2015 Praxis Life Sciences USAV alidation Center 8 2015 Praxis Life Sciences FDA 21 CFR 11 Electronic Record; Electronic SignaturesSubpart B Electronic Records, Sec.

5 Controls for closed procedures and controls shall include the following: (a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered CFR 820 Quality System RegulationSubpart C Design Controls, Sec. (g) Design Validation shall include software Validation and risk analysis, where appropriateSubpart G Production and Process Controls, Sec. (i) When computers or automated data processing systems are used as part of production or the quality System , the manufacturer shall validate Computer software for its intended use according to an established protocol.

6 All software changes shall be validated before approval and issuance. These Validation activities and results shall be Regulatory RequirementsReproduction or re transmission in any form or by any means, electronic or mechanicalwithout prior written permission from Praxis is prohibited. 2015 Praxis Life Sciences. All rights Center Life Sciences | West Field Court, Suite 125, Lake Forest, IL 60045 | +1 (847) 295 71605 USAV alidation Center 9 2015 Praxis Life Sciences FDA 21 CFR 211 Current Good Manufacturing Practice for Finished PharmaceuticalsSubpart D Equipment, Sec. (b)Input to and output from the Computer or related System of formulas or other records or datashall be checked for accuracy.

7 21 CFR 1271 Human Cells, Tissues, and Cellular and Tissue Based Products Subpart D Current Good Tissue Practice, Sec. (d)You must validate the performance of Computer software for the intended use, and the performance of any changes to that software for the intended use, if you rely upon the software to comply with core CGTP requirements and if the software either is custom software or is commercially available software that has been customized or programmed (including software programmed to perform a user defined calculation or table) to perform a function related to core CGTP requirements. CSV Regulatory RequirementsEuropean UnionValidation Center 10 2015 Praxis Life Sciences EC COUNCIL DIRECTIVE 93/42/EECANNEX IESSENTIAL For devices which incorporate software or which are medical software in themselves, the software must be validatedaccording to the state of the art taking into account the principles of development lifecycle, riskmanagement, Validation and verification.

8 Austria Belgium Bulgaria Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Poland Portugal Romania Slovakia Slovenia Spain Sweden United KingdomEudraLex Volume 4 Good Manufacturing Practice, Medicinal Products for Human and Veterinary UseAnnex 11 Computerised SystemsThe application should be validated; IT infrastructure should be qualified. CSV Regulatory RequirementsReproduction or re transmission in any form or by any means, electronic or mechanicalwithout prior written permission from Praxis is prohibited.

9 2015 Praxis Life Sciences. All rights Center Life Sciences | West Field Court, Suite 125, Lake Forest, IL 60045 | +1 (847) 295 71606 BrazilValidation Center 11 2015 Praxis Life Sciences Brazilian ANVS Good Practices of Medicament ManufacturingTITLE VIII GOOD PHYTOTHERAPIC MEDICAMENTS MANUFACTURE PRACTICES, CHAPTER IV Validation , Art. 18. Any aspect of operation, including significant changes in the facilities, location, Computer systems, equipment or processes that can affect product quality, directly or indirectly, must be qualified and / or VII, Computer INFORMATION SYSTEMS, Art. 573. Validationshall be considered part of the Computer System s life cycle, which includes the planning, specification, scheduling, test, documentation, operation, monitoring, maintenance and change Regulatory RequirementsJapanValidation Center 12 2015 Praxis Life Sciences Japan s Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi drugsThe purpose of this guideline is.

10 To ensure proper enforcement of the Standards for Quality Assurance for Drugs, Quasi drugs, Cosmetics and Medical Devices .. and the Standards for Manufacturing Control and Quality Control for Drugs and Quasi drugs .. by ..specifyingthe necessary matters during development of computerized systems, the Validation items to verify such systems, .. in order to ensure such systems function as Regulatory RequirementsReproduction or re transmission in any form or by any means, electronic or mechanicalwithout prior written permission from Praxis is prohibited. 2015 Praxis Life Sciences. All rights Center Life Sciences | West Field Court, Suite 125, Lake Forest, IL 60045 | +1 (847) 295 71607 ICHV alidation Center 13 2015 Praxis Life Sciences ICH Q7A, Good Manufacturing Practice for Active Pharmaceutical IngredientsGMP related computerized systems should be validated.