validación de sistemas de gestión de negocios 2.0. ndesistemasdegesti... ·...

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1Validación de Sistemas de Gestión de Negocios (ERP)

Validación de Sistemas de Gestión de Negocios (ERP)

Validación de Sistemas de Gestión de Negocios (ERP)


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World’s changes

The Pharmaceutical Industry has adapted its business model in response to growing industry constraints and the decline of the primary-care focused blockbuster therapy.

Principal Key Success Factors in this “scenario” are:

Maintaining Quality

Optimising Process

Cost Management

Reducing Time to Market

Optimising Supply Chain

Latino America Consultores, with its experience, is one of the most Qualified Partners in South America to achieve that goal, according to cGMP requirements, with a special focus on Pharmaceutical Business Evolution.


International Support

Momentum Life Science™

Support in R&D

Engineering, Design & Construction Support

Qualification, Validation & Management

Technology Transfer

IT in Compliance

Business Development & Alliance

Regulatory Affairs

Quality in Outsourcing & Auditing

Training

Business Process Re-engineering

Feasibility Studies

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Product Knowledge

Product & Process Support Supports for Formulation, Pilot Phases, Scale Up and Industrialization Process Qualification Technology Transfer Support

Regulatory Affairs & Compliance International Regulatory Support Supports in Preparation Dossiers Supports in Preparation of Technical File for Medical Devices Preparation and Implementation of Variation Procedures

Engineering

Project: URS, Feasibility, Preliminary Budgeting, Conceptual Design, Basic Design, Detailed Design, Design Qualification

Verification: Equipment & Plant Qualification Support, Utilities Qualification Support, Analytical Methods & Equipment Qualification, Information & Data Management System Validation

Compliance, Innovation & Data ManagementERP, LIMS, DCS, SCADA, WMS, EDMS have to be in Compliance.

Feasibility Study & Software & Supplier Selection

Solution Providing & System Integration Support

Computer System Validation (GAMP 5.0), 21 CFR 11 Compliance

GxP Risk Assessment & Remediation Plan Management

Support for IT Infrastructure Management & Enhancement, Networks Qualification

Legacy System Assessment & Full Plant Remediation Support


ERP ValidationMain ERP Structure

Basic Strategy

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ERP: Example

Generic Architecture


Diferencias

Estructura Modular Módulos Independientes vinculados por un

Mecanismo de Transacciones Cada Modulo puede tener una interface Altamente Configurable Customizable usando lenguaje ABAP Implementación por Expertos Documentación estándar de implementación

(ASAP/Blueprint) Corporate Validation Support

Diseño en base a Funcionalidades Posee un sistema de interface particular utilizando

SQL (SQL Database Transaction) Altamente Configurable Customizable utilizando un ambiente Microsoft Implementación por Analistas y Expertos MS/SQL Paquete opcional de compliance (Process Industries) Configurable por un Menú Estándar Compatibilidad con Office Nativa (Data Import/Export)

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Principle

For both Systems a Process Mapping & RiskAssessment activity is mandatory;

For SAP it’s mainly dedicated to identify theConfigured Transaction and the CustomizedFunction (if present)

For AX it’s mainly dedicated to identify minimalconfiguration detail and customization

Approach


Full Assessment – Metodology

DELIVERABLES

Prj.Planning&

Inventory

1

SystemsList

GMP&

Risk Assessment

2

Activity

Assessment21 CFR Part 11

3

GapAnalysis

4

Planning

5

Risk Assessment

Report

SystemAssessment

Report

GapAnalysisReport

ActionPlan

RemediationPlan

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ERP ValidationSAP

Validation Approach


=

Unsolvable Situation

“Después de haber eliminado lo imposible, lo que queda, por improbableque sea, debe ser la verdad”

Arthur Conan Doyle - Sherlock Holmes, 1890

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Typical Situation

Complex Configuration, apparently without enough documented evidence (not totally accurate)

Huge number of transaction, with a long history

Insufficient level of test during project release phase

NO Change Control Management in place (usually insufficient and NOT documented)

Few Resources could be dedicated to perform validation

The project is TOTALLY left to external consultants

RESULTS:

1. Project Duration: from 6 month to over than one year

2. Negative impact on the structure

3. The company has no control of the project and does not develop a real understanding of the processes


¿Cómo podemos mejorar esto?

¿ ¿ Mission Impossible??

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SystemsSystem Level

Impact Assessment

Funcional Level

Impact Assessment

syst

ems Direct

Indirect

No Impact func

iona

litie

s

Critical

Non Critical

Risk Based Approach


Risk Assessment Document (RA Datasheet, RA Report, Collected Lists & Documents)

Validation Plan (Scope , Objectives, Roles & Responsibility, Activities & Deliverables, Criteria, ManagementIssues, etc)

Traceability Matrix (Links & dependences between RAR – Mitigation/Corrective Actions – FRS v/s Testing ,SDS v/s Testing, Findings v/s SOP, etc)

Functional Requirements Specification (Main Document, User’s Process Flow, Blue Print, SAPManuals, Configuration Documents, Customization Documents, SAP’s Projects Documents, SAP Guides, Listof Transactions, Process SOP, System’s Working Instruction and Application Manuals)

System Design Specification (System general architecture, Specific Connection /System Mapping scheme,Technical document of the equipment, general connection scheme, SOP for system management &maintenance, document for SAP standard installation reports, )list of installed components, SAP environment’sgeneral documents and History, basic IT Dept. Working instruction & rules, Development Environments rulesand document), etc

Document for Testing (Test Plan, SAP Unit Test, SAP Module & Integration test, SAP?s Installation TestSummary, Installation Qualification, Operational Qualification, Performances Qualification)

Summary Report (Activity Detailed Report, List of Deviation, Open Issues, Action/Validation Plan for futuresteps Upgrade)

Document Hierarchy

Optimising Existing Project Document, Integrating what is missing up to the sufficient level to describe CRITICAL SYSTEM FUNCTIONS and to test them

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FRS FunctionalRequirements

Description

SAP Name

Transaction

Process Block Diagram / Flow Chart

CodeVersion

StatusTechnical Doc.

CodeStatus

Version

Operational Qualification

OCASA Code

Status

Version Date

Validation Master Plan

Approach, Scope, Responsibility, Deliverable, Criteria, Remediation Steps

Draft Scheduling

Risk Assessment

RAR-XXStatus

Version Date

SDS System Design

Description TypeScope

Installation Qualification

OCASA Code

Scope

Descr.Conditions

IQ Report Results Comments TO DO

Action Plan RAR-XX CA XX CC

Traceability Matrix

RAR-XXX-YYY

Detailed Scheduling

CAXXX

OWNER

Working Instruction

CodeStatus

Version

Procedural Remediation

SOP DescriptionOwner

Technical Remediation

Description Obj. Note

Change CodeStatus

Version

Status

Transaction

Code

Version

LinkTypeDesc.

ManualCode

Version

LinkTypeDesc.

OwnerLink

Link

Technical Doc.

CodeStatus

Version

Expec. Result

Result

OQ Report Results Comments TO DO

Document Hierarchy


Project Start

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Nombre actividad Duration Start Finish Predecessors

Preparacion Documentos de Validacion

15 d Mon 23/07/12 Fri 10/08/12

Preparacion FRS e SDS Start Up 1d Mon 23/07/12 Mon 23/07/12 10

Desarrollo FRS 10 d Tue 24/07/12 Mon 06/08/12 12

Desarrollo SDS 10 d Tue 17/07/12 Mon 30/07/12

Revision FRS e SDS 4 d Mon 30/07/12 Fri 03/08/12

Risk Assessment P11 y AnalisisSOP

2 d Wed 01/08/12 Fri 03/08/12

Project Monitoring


Nombre actividad Duration Start Finish Predecessors

Etapa de Testing 19 d Mon 13/08/12 Thu 06/09/12

Desarrollo IQ 3 d Mon 13/08/12 Thu 16/08/12 16

Desarrollo OQ 5 d Mon 13/08/12 Mon 20/08/12 15

Ejecucion IQ 3 d Thu 16/08/12 Tue 21/08/12

Ejecucion OQ 10 d Tue 21/08/12 Mon 03/09/12 20

Preparacion PQ 2 d Thu 30/08/12 Mon 03/09/12 21

Cierre de las Actividades 2 d Mon 03/09/12 Wed 05/09/12

Interim Validation Report 2 d Mon 03/09/12 Wed 05/09/12 22

Project Monitoring

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Project Highlight

Significant ITEM DATA Users 600SAP Modules Fi-Co, TR, SD, MM, LOManaged Environment DEV, QA, PRODSites Managed 7 (actual + future)Total Transaction Active 138Total Transaction Customised 14Totale Critical Transaction (Impact GMP)

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Document Prepared 25Consultant Team 2 Full Time

3 Part timeCustomer’s Team 4 Full time (70% time equivalent)

Key Users ONLY for RevisionProject Duration 3 months


ERP ValidationAX

Validation Approach

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System Configuration


System Architecture

Dynamics R. 8 (2009)

CUSTOM APPLICATION

Especialización Industria

Desarrollos Terceros

Desarrollos Propios

Configuración Corporativa Fundamentos

(Best Practices)

AX PHARMA

El esquema representa la Estructura Lógica de un ERP Corporativo.

MS Axapta® 2009, Especialización Industria, y Paquetes de desarrollos de terceros representan la Capa de Software instalado dentro de la suite comercial de Microsoft®.

Desarrollos Propios y Configuración son configuraciones específicas de un Cliente realizadas dentro del entorno MS® para cubrir las Mejores Prácticas disponibles.

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Identify the Process Model (Process Flows / Process Mapping)

Use the existing Information

Involving the Key Users and the IT

Applying the Risk Analysis to identify the “Real Impact” and the Real Criticality, and to put in place additional controls &/or corrective actions

Verify the applicability of controls and corrective actions depending on the structure, internal capabilities and impact on business processes

How to Proceed


• What kind of Process are executed?• What kind of Scope?• Consistency?• GMP Impact?

HOW

• The Process is done in this way?• It’s critical?• I need to control here?• Are there additional control?

WHY

• FIX TO DO IT BETTER• Short Term Improvement /

Procedures• Minimize impact

FIX

• Identify Test • Execute test• Consolidate, Report , identify Open

Issue

Validate/ Control

• Set Change Control Procedures• Set PQ Long Term• Close Open Issues• Change Management

IMPROVE

Business Process Management

D Design

M Model

E Execute

M Monitor

O Optimize

BPM Methodology Applied to the Project

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Using Risk Based Approach

METODOLOGÍA DEL ANÁLISIS DE RIESGO La metodología del Análisis se aplica de acuerdo

con los siguientes pasos:

1. Mapeo de Procesos (GxP)2. Identificación de Funciones Criticas3. Identificación del Escenario de riesgo4. Evaluación de probabilidad5. Evaluación de severidad del impacto6. Asignación de clasificación al riesgo7. Evaluación de la probabilidad de detección8. Asignación de prioridad al riesgo

El riesgo está basado en la identificación de un “Evento o Escenario de Riesgo”. Para cada amenaza al sistema, se identifica un posible evento de riesgo, relacionado con una operación-no correcta y/o una potencial corrupción o incumplimiento GxP de los datos que se manejan. Los posibles eventos relacionados a un mal funcionamiento del sistema se listan en el Risk Assessment Report.A cada riesgo se asocia una acción correctiva que va a impactar en la validación del sistema.


RA - Risk Assessment

VP Validation

PLAN

TM Traceability

Matrix

FRS Functional Requirements Specifications

SDS System Design

Specifications

IQInstallation

Qualification

OQOperational Qualification

RA Datasheet RA Report

(RAR – CA) Collected Lists &

Documents

RA Results Scope , Objectives Roles &

Responsibility Activities &

Deliverables Criteria Management

Issues Draft Scheduling

RAR CA Type Description Owner Status Reporting/TO

DO PLAN

FRS ref . & IQ CODE Scope &

Description Test Conditions Expect. Results Collected Result Report

Main Document User’s Process Flow, & Blue

Print Manuals Implementation Project

Documents Configuration Docs Customization Docs User’s SOP, Application

Manuals

PQPerformances Qualification

Process Item / Process Flow Id. Process

Description Scope of Test &


System general architecture Equipment Technical

Datasheet System’s SOP Standard installation reports System Installed components System environment’s IT Working instruction & rules

System Risk Based Assessment& Remediation Planning/Controls System Description System Testing

DOC Hierarchy

SDS ref. & IQ CODE Scope &


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Stage & Gate & Responsibility Matrix

KickOff

Assessment Mapping &

Plan

Dynamics ValidationG0 G1

Interface Validation G7

G-1 Dynamics Validation

Final Interim Validation Report

G2

Mes 0

Time Line

Mes 6


Project HighlightSignificant ITEM DATA Users 200AX Functions Production, Warehouse, Quality Control,

Maintenance, Quality Assurance, Dispensing, ecc.

Managed Environment DEV, PRESites Managed (2 + Corporate Standard)Total Funcionalities Active + 400Total Funcionalities Customised + 25Total Critical Funcionalities(Impact GMP)

+150

Document Prepared 14Consultant Team 2 Full Time

2 Part timeCustomer’s Team 10 Part time Key Users (50% time

equivalent)

Full time IT Project Manager (70% time equivalent

Project Duration Phase I 3 months

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Computer System ValidationGeneral Considerations


Lesson Learnt

Using Risk Based Approach to Identify Critical Business Processes and preliminary evaluating Business & GMP Impact the for all Critical key Process Steps has produced a significant impact (validation effort focused and reduced by around 40%)

Using the deep Knowledge of the customer’s IT Team, according type and contents of technical document allows to work in parallel, sharing and improving on both sides system’s knowledge and project controls

The Consultant Team support Protocol Preparation very well supported by the Internal QA, Tech Team and Key Users, working in parallel using best knowledge on both sides to make the activity faster, time effective and more complete.

User team develop and prepare SOP and working instructions to support Validation and testing;

During the Project an AUDIT has been supported;

The Consultant Team act as a Tutor / Supervisor, while the Customer’s Team obtain System and Project Ownership

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Comply International Rules show Innovation,Knowledge & affordability, and it’s a PowerfulBusiness Item

Design an Qualifying Process, Systems & Plant incompliance with FDA or EMA requirements,means that the Product, once ready to export, arecompatible with the most restrictive internationalrules;

A structure prepared to manage qualified processmeans reduction of Technology Transfer Time ,both IN & OUT;

An Integrated QMS, supported by QualifiedProcesses & Systems, reduce Inspection Risksand Inspection Preparation Time;

Qualified Processes means reduction ofRegistration Time

A Full Compliant Plant increase Group Trust andGroup Visibility

Benefit of Compliance


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Muchas Gracias por su Atención

Leandro Mbarakleandro.mbarak@latconsultores.com.arwww.latconsultores.com.ar

Gilberto Rossigilberto.rossi@latconsultores.com.arwww.latconsultores.com.ar