La presentazione è in caricamento. Aspetta per favore

La presentazione è in caricamento. Aspetta per favore

Dr. D. Marcozzi Head of Clinical and CSV QA dept. of SIGMA-TAU Milano, 31 marzo, 2005 Qual è il Processo della Computer System Validation? Riunione Gruppo.

Presentazioni simili


Presentazione sul tema: "Dr. D. Marcozzi Head of Clinical and CSV QA dept. of SIGMA-TAU Milano, 31 marzo, 2005 Qual è il Processo della Computer System Validation? Riunione Gruppo."— Transcript della presentazione:

1 Dr. D. Marcozzi Head of Clinical and CSV QA dept. of SIGMA-TAU Milano, 31 marzo, 2005 Qual è il Processo della Computer System Validation? Riunione Gruppo GCP

2 Parleremo di: FORNITORI CONVALIDA Nuova visione delle CONVALIDE Analisi e Gestione del RISCHIO

3 Cosè la CONVALIDA? Si si …un bel vestito….

4 Cosè la CONVALIDA?

5 Mi dicono che avrei fatto una CONVALIDA??

6 Cosè la CONVALIDA? O meglio………….

7 Che cosè la Computerized System Validation (CSV)

8 Primo: cosè un Computerized System? Personnel Software Documentation Instrument Hardware Documentation Control System Operating Environment Procedures Infrastructure

9 Validation is…. Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes

10 Current Validation is the entire procedure of gathering documented evidence that a computer-related process or a system performs according to its intended function reliably and consistently throughout its life.

11 Documented Process/system Pre-Determined Quality Attributes Entire Procedure Reliably and consistently Life Le parole CHIAVE

12 The life cycle concept of Computer Validation Validation is a PROCESS, not an event Validation activities span the entire System Life Cycle: Planning Requirements Analysis Design Implementation Testing Acceptance On going Retirement

13 Requirements System Selection Specify & Design Build Supplier Testing User Qualification Operation Maintenance Documentation Planning and Implementation A Life cycle approach

14 URS FSOQ DS PQ IQ System Build Planning and Implementation A Life cycle approach

15 Planning Specifications Test Planning (IQ,OQ,PQ) Review Validation Plan URS, FS, DS (required) Doc. come testare il sistema Validation Report TestingTest e risultati Planning and Implementation A Life cycle approach

16 Validation activity and life cycle PROJECT ACTIVITY USER REQUIREMENTS FUNCTIONAL SPEC. HW E SW DES. SPEC. SW MODULE DES. SPEC. MECH. & ELECTRIC SPEC. HW MANUF. & ASSEMBLY CODE SW MODULES EQUIP. MANUF. & ASSEMBLY HW TESTING SW MOD.& INTEGR. TESTING EQUIP TESTING HW, SW, EQUIP. INSTALL. HW ACCEPTANCE TESTING SYSTEM ACCEPTANCE TEST. MAINTENANCE CHANGE CONTROL LIFE CYCLE PHASE PLANNING & SPECIFICATION DESIGN CONSTRUCTION TESTING INSTALLATION ACCEPTANCE TESTING OPERATION VALIDATION ACTIVITY VALIDATION PLAN SUPPLIER AUDITS SPEC. REVIEW DESIGN REVIEW COSTRUCTION & CODE REVIEW MONITOR SUPPLIER IQ OQ PQ VALIDATION REPORT ONGOING OPERATION

17 Validation Scope and Effort should be commensurate with impact and value of data, process, results... size and complexity of the system and how critical it is in your routine and non-routine operations

18 Tanto più un sistema è critico e complesso tanto maggiore sarà lo sforzo di convalida…quindi…

19 Sistemi Standard Sistemi Customizzati Sistemi Be-spoke

20 Basic Approach to Validation Validation is a process, not an event Planning activity should be performed as a Team Keep the validation process under control

21 Le finalità….da GCP Qualora si avvalga di sistemi elettronici di elaborazione dei dati e/o sistemi di inserimento a distanza per la gestione dei dati relativi alla sperimentazione, lo Sponsor…. Garantire e documentare che il sistema elettronico per lelaborazione dei dati sia conforme ai requisiti di completezza, precisione, affidabilità stabiliti dallo Sponsor e che questi siano conformi alle caratteristiche prefissate (cioè Validazione)

22 Le finalità Validating Data Validating the System handling the Data

23 Nel 1999… lFDA Pubblica una nuova Guidance for Industry Computerized System Used in Clinical Trials Per essere accettabili, i dati debbono soddisfare certi elementi fondamentali di qualità se raccolti e registrati elettronicamente o su carta I dati debbono essere: ttribuibili (Source & Recorder are Known) eggibili (Human readable) ontemporanei (Recorded when observed) riginali (Honest data/not fraud) ccurati (Correct, repeatable results) A L C O A

24 ALCOA

25 Ed ora… gli attori… CLIENTE FORNITORE

26 CLIENTE FORNITORE

27 USER IT QA CLIENTE

28 COMMERCIALE e…… FORNITORE

29 QA According to specific rules or guidelines defined for each environment

30 Il peso del QA…. IT QA

31 Il peso del QA…. Qualità della documentazione Requisiti Regolatori Requisiti di Processo Requisiti Tecnici Pianificazione e Testing Qualifica dei fornitori QA IT

32 Il QA… ovunque nella CSV Valutazione Fornitori Risk Assessment Definizione Requisiti Utente Definizione delle politiche di convalida Piani e test di convalida Revisione ed Approvazione dei documenti di convalida

33 Approvazione dei cambiamenti Revisione ed Approvazione delle SOPs di convalida e CSV generali Audit periodici Punto di riferimento normative CSV

34 E le SOPs? Training Vendor Evaluation Gestione Documentazione di Convalida Change Control Configuration Management Problem Reporting Security Back-up Restore Archiving Clinical Data Maintenance Disaster Recovery/Business Continuity Periodic Review QA

35 COMMERCIALE e…… FORNITORE

36 PQURS FS OQ DSIQ System Build Planning and Implementation A Life cycle approach

37 Evaluation should preferably be derived from a reliable audit of the software developer (supplier), performed by the end users organization or a trusted and competent third part.

38 Da GMP….....Validation should be considered as part of the complete life cycle of a computer system. This cycle includes the stages of planning, specification, programming, testing, commissioning, documentation, operation, monitoring and modifying… (by supplier!). The software is a critical component of a computerized system. The user of such software should take all reasonable steps to ensure that it has been produced in accordance with a System of Quality Assurance.

39 CS Validation Documents Client responsibility Supplier responsibility Planning GAMP Specifications Testing Validation Summary On-Going Test Plan Design Spec. Functional Spec. Quality and Project Plan Factory/Site Acceptance Test Master Index Validation Report. Report IQR, OQR, PQR Audit Report Validation Plans Validation Master Plan User Requirement Specifications SOPs Protocolli DQ, IQ, OQ, PQ SOPsUser Manuals

40 Why do we have to audit the Suppliers? The primary purpose of an audit is to assess the controls, procedures, and practices which are in place for the development and maintenance of a product The primary purpose of an audit is to assess the controls, procedures, and practices which are in place for the development and maintenance of a product Is a form of review that provides confidence concerning the validity and accuracy of a product or process now and in the future Is a form of review that provides confidence concerning the validity and accuracy of a product or process now and in the future Audits should be viewed as a learning experience and should be conducted as a cooperative effort Audits should be viewed as a learning experience and should be conducted as a cooperative effort

41 SW Supplier Evaluation To ensure that the supplier produces a quality product, and to obtain information to plan computer validation activities Tools Collection of available information Request for Information (questionnaire) Audit Follow up Intent

42 COSTS RISKS EVALUATION THROUGH REFERENCES EVALUATION THROUGH EXPERIENCES REQUEST FOR INFORMATION 3RD PARTY AUDIT SPECIFIC FIRM AUDIT Supplier Evaluation Tools

43 Supplier Qualification model Information from other companies or from market Request for Information (RFI) Telephone Audit Site Audit SYSTEM RISK CATEGORY EVALUATION COST

44 Check…Independence of SW Validation Validation activities should be conducted using the basic quality assurance precept of independence of review. Self-validation is extremely difficult; an independent review is always better.

45 Computer system validation should be performed by persons other than those responsible for building the system. Check…Independence of SW Validation

46 Validation: Client Responsibility ! Validation: Client Responsibility ! Manufacturer has flexibility in choosing how to apply the validation principles, but retains ultimate responsibility for demonstrating that the software has been validated. Normative Guidelines PLANNING

47 Client Responsibility ! Client with regulatory responsibility needs to assess the adequacy of the software developers activities and determine what additional efforts are needed to establish that the software is validated.

48 ...but Validation Responsibility is always on the Clients side Supplier selection (and supplier) is important

49 Validated Packages dont exist!! Supplier may provide a Validation Package, showing that the standard version of the product has been validated in Factory Client has to perform an on-Site Validation

50

51 Quindi…. La validazione è una nostra responsabilità Si deve Validare nel nostro ambiente Non è una responsabilità del Fornitore del sistema I sistemi forniti (anche quelli più standard) sono validabili, da validare e non già validati

52 Quanto più il fornitore è affidabile…di QUALITA Tanto meno sforzo di convalida dovremo pianificare Dopo e sempre Validare!!! Prima Verificare!!!

53 Ora parliamo di RISK MANAGEMENT…. RISK ANALYSIS….. Solo un accenno…. prendiamo spunto dalla realtà!

54

55

56 Da FDA…. Pharmaceutical CGMPs for the 21 st century A Risk-Based Approach Final Report september 2004 In August 2002, FDA announced a significant new initiative, Pharmaceutical Current Manufacturing Practices (CGMPs) for the 21 st Century, to enhance and modernize the regulation of pharmaceutical manufacturing and product quality for veterinary and human drugs…. Objective: Encourage implementation of risk-based approaches that focus both industry and Agency attention on critical areas

57 Da FDA…. 21 CFR Part 11 Guidance… Whit the issuance in 2003 of the guidance for industry part11, Electronic Records, Electronic Signature- Scope and Application, many barriers to scientific and technological advances were removed, and the use of risk-based approaches to managing computer systems is encouraged.

58 Risk Analysis / Computer Validation Protect against the risks to patient safety Maximize the business benefits Help to determine the extent of validation Give a rationale to justify Validation approach in case of Inspection Concentrate the validation effort

59 A Good Start Perform Assessment Dove siamo? Dove vogliamo andare? Da cosa cominciamo?

60 Risk Analysis: the Value The more you know about your computer system Test The more you focus the validation Better you will use your resources…. and money!

61 Nuovo approccio alle Convalide….

62 Nel 1990 G AM P… Good Automated Manufacturing Practice Scopo della linea-guida è quello di assistere le aziende farmaceutiche, biotecnologiche, medical devices nellimplementazione di sistemi automatizati validati e compliant con i requisiti normativi Nasce nellambiente GMP

63 …nuove GAMP… 2001 Le nuove GAMP coprono tutti i requirements GMP, GCP, GLP e GDP Si potrebbero chiamare GA M-C-L-D P Più attenzione al Processo!

64 Nuovo approccio alle Convalide….

65 Da…Performance ProcessA….. QUALIFICATION !

66 FINE….. Grazie per la PAZIENZA!!


Scaricare ppt "Dr. D. Marcozzi Head of Clinical and CSV QA dept. of SIGMA-TAU Milano, 31 marzo, 2005 Qual è il Processo della Computer System Validation? Riunione Gruppo."

Presentazioni simili


Annunci Google