Business Systems Validation / ERP Project Assurance

SAP compliance: Delivering the benefits

Business projects assurance

ABB Engineering Services - Life Sciences has an enviable track record of working with our key clients, helping them manage the implementation of complex SAP systems. We work closely with our clients to achieve early success and payback from their IT investments. Our SAP validation approach and project accelerators have been proven on many SAP implementations. These accelerators and our ERP project leadership experience have contributed significantly to effective project execution. Our approach centres on an holistic analysis of how the system will be used and interfaced to the entire operation with a direct alignment with the business aims of the project.

What does business project assurance involve?

Our assurance programme involves the effective management of three business critical issues, these are: Business assurance The objective of business assurance is to ensure project deliverables are integrated into an integrated business validation and compliance process. The key drivers for this are minimisation of business interruption and compliance to external business audit requirements, both GxP and SOX.

Project management assurance Project management assurance aims to manage project risk and ensure the project delivers on time, in full and in line within a planned budget. The integration of project practices with other partners is a key part of our process to ensure the whole project team is performing at the highest level.

Technical and regulatory assurance Technical and regulatory assurance seeks to develop a controlled development of an SAP system design. The system must be reliable and fit for purpose in line with the project objectives and regulatory requirements. Key drivers are management of project deliverables to technical standards, achieving and maintaining the GxP licence to operate, and financial regulatory compliance (Sarbanes Oxley). Our practices follow a structured method to achieving technical and regulatory assurance, improving the reliability and availability of business critical systems. Regulatory compliance protects your corporate image, shareholder value and your manufacturing license.

Our project approach has been shown to deliver ERP implementations to higher quality with fewer resources than other similar projects

Business Systems Validation

How is this delivered?
The SAP assurance programme consists of a set of techniques used to manage an ERP project. The aim is to drive out action plans to ensure seamless integration of new technology, operating practices and procedures into the organisation. The techniques include: + Business Blueprint + Business process mapping, data flows and transactional analysis across applications + Integrated project execution and validation methodologies + Standard Operating Procedure analysis and modification + Business process testing and validation + Quality Management Systems - design and management + People and culture change management + Job design, training needs analysis and training delivery (Business process and GMP training) + IT project management + Business systems: SAP project phases:
+ + + + + + Project Definition: project assessment process, validation planning, risk assessment GxP and project Business Blueprint: to capture and specify master data, security, technical and module functional requirements Realisation: Testing and design specifications to include transaction, workflows, data migration and configuration Final Preparation: Project team and end user training. Data harmonisation and migration activities Release & Use Cutover - planning and cutover activities, validation reports & release management Go Live and Support: Cutover report and performance monitoring

ABBs validation and project accelerators coupled with system specific technical SAP knowledge (including Warehouse Management, Laboratory Information Management, IT Infrastructure, Process Control systems) and system management experience enable ABB to tailor its ERP Project Assurance Programme to meet the requirements of a wide range of technologies and clients. Our consultants are experienced in applying standard ERP implementation methodologies with the greatest impact to SAP projects. + Post cutover
+ Principles of post cutover validation + Cutover report + Performance monitoring + Overview of ABB ERP Validation Lifecycle + Following the ABB Gate Model + Project assessment process + Governance principles for ERP projects + Validation planning + Master validation plan + Module validation plan + Quality plan + Risk assessment + Module & transactional code GxP evaluation + Transaction code evaluation + Project risk assessment

+ Training + Introducing training + Project team training + End-user training + Data harmonisation & migration + Release & Use Cutover + Introduction to cutover & release of systems to operational use + Cutover planning + Module validation reports + Cutover simulation (plans) + Cutover activities + Release notice

Pr

Live & Support Go al Preparation Fin Realisation s Bluep ines rin us B ect Defini ti j o
on

ERP / BSV

+ Design + Transaction design specifications + Software design specifications + Interface specifications + Workflow specifications + Data migration specifications + Reports & forms specifications + Authorisation specifications + Configuration specifications

+ Testing + Installation Qualification (IQ) & reporting + Operational Qualification (OQ) & reporting + Performance Qualification (PQ) & reporting + Cutover Qualification (CQ) & reporting + Unit test specifications (OQ) + Transaction tests (BPPs) + Enhancements test specifications + Interface tests + Workflow tests + Data migration (Conversions) tests + Reports & forms tests + Authorisation tests

+ Specifying / requirements capture + Introduction to requirements capture + User requirements + Module functional requirements + System landscape requirements + Master data requirements + Technical requirements + Security (Authorisation requirements)

Our experience covers the full range of pharmaceutical business processes, represented by the core SAP modules and focus areas for regulatory compliance.
Sales Distribution Finance Controlling

Human Resource

Materials Management

Warehouse Management

ABB has an extensive SAP capability, with up to the minute experience of the current SAP applications. With access to ABBs internal competence, ABB Engineering Services can provide direct experience of implementing and operating SAP systems to support your projects and IS support departments. Our risk based approach to criticality assessments and associated validation strategy ensures a cost effective approach to ERP system compliance. We focus effort and resources on critical areas resulting to reduce validation costs for the project. With an integrated approach to organisational change, project management and validation ABB can deliver the greatest business benefit in terms of business operation, project outcome and audit exposure. ABB has a wide range of expertise and experience in delivering business ready technical solutions in the pharmaceutical sector.

ABB Limited Daresbury Park Business Centre Daresbury Warrington Cheshire WA4 4BT United Kingdom Tel: +44 (0)1642 372077 Fax: +44 (0)1642 372111 E-mail: lifesciences@gb.abb.com www.abb.com/lifesciences

FLY559a/04/08

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Production Planning

GxP SOX

Quality Management