PAS X. Competence. Implementation. Support. Services Overview. PAS-X Services. Global Service Centres

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1 PAS-X

2 PAS-X PAS-X Overview Global Service Centres Following the global approach Werum provides 24/7 global services and support backboned by the Service Centres in Parsippany, USA; Lueneburg, Germany; and Singapore. Service Portfolio Our commitment to high-quality products needs to be underpinned by an equally good spectrum of services and support. Our services are carried out by technical specialists who direct all their expertise and experience towards satisfying the customer. You can rely on our services throughout the entire lifecycle of your MES solution. Competence PAS X CONSULTING PROJECT MANAGEMENT VALIDATION SYSTEM INTEGRATION TRAINING Implementation Support SERVICE DESK LIFECYCLE MANAGEMENT 1

3 PAS-X PAS-X Consulting Our experienced team of specialists offers a broad range of consulting services to ensure effective and secure management of your project. Make use of our expertise for your project: - Analysis of system architecture and business processes - Preparation of User Requirements Specifications, GAP documents and Functional Specifications based on standards - Integration of shop floor systems by means of standard interfaces - Proposals for increased efficiency - Modeling of processes in the field of MBR creation - Validation consulting based on a master plan - Distribution of functions between MES and ERP system as well as integration of the two systems - based on existing standards Project Management Our project managers see themselves as your partners. This philosophy is a key factor in implementing complex projects successfully, on time and within budget. Werum s project managers are experienced members of staff with outstanding technical competence: - Overall project management of GMP projects - GAP analyses, pilot systems, specifications - Implementation of user requirements based on Werum s product packages - Vertical and horizontal integration - Testing, commissioning and go-live - Validation - Lifecycle management 2

4 PAS-X PAS-X System Integration Werum offers comprehensive services to enable a smooth integration of the PAS-X MES product. We assume overall responsibility for the introduction of the MES system - starting with the design phase via the technical coordination of the project, including coordination with third-party suppliers, all the way through start-up procedures for the operational system. PAS-X provides predefined standard interfaces, which fully integrate PAS-X with all existing standard systems available on the market. If there are additional integration needs, we will cover your requirements by expanding our solution or developing a new customized solution. We make sure that we stay within the time limits, quality requirements and price agreements defined. 3

5 PAS-X PAS-X Validation Support Validation is a crucial element in introducing a computerized system for use in a regulated environment: - Review of the customer s QM system in terms of computer system validation requirements - Identification of the required documents and agreement on methods to be used for writing them - Preparation of a validation plan - IT risk analysis and description of computerized business processes - Test specification and implementation: - Use of tools to provide complete transparency of traceability - IQ based on the installation plan and system manual - OQ based on the business process description and risk analysis - PQ based on the User Requirements Specification SDLC Approach based on GAMP5 Planning Reporting Traceability Specification Verification Development 4

6 PAS-X PAS-X Training PAS-X Training Courses To train and qualify your staff according to your specific needs we offer standard PAS-X training courses, which will lead to three successive qualification levels building up on each other: COMPACT (Bronze) The COMPACT training course provides an overview of the basic concepts and essential functions of PAS-X. This course is designed as an entry point to PAS-X and as a means to get to know its fields of application. The COMPACT course is intended for decision makers and key users. BASIC (Silver) The BASIC training course provides an overview of the underlying business processes as well as of the regulatory and organizational framework within which a manufacturing execution system can be used. Based on the virtual model of a plant these business processes are mapped to and represented in PAS-X. And guided work at the system helps participants to gain in-depth knowledge. The BASIC course is intended for key users, MBR modelers and production supervisors. PRO (Gold) The PRO training course provides detailed information about PAS-X - with a particularly close focus on its subsequent application-specific use. In this course, examples and exercises from the following alternative fields are used: - Chemical API production - Biopharmaceutical production - Pharmaceutical production (liquids and solids) - Fill & Finish - Packaging It is also possible to incorporate customer-specific examples in the course to make training exercises as realistic as possible and to achieve a higher degree of detail. With this approach, the training passes gradually over into a workshop that is individually tailored for the customer. The PRO course is intended for key users, MBR modelers, production and QA supervisors. 5

7 PAS-X PAS-X Training FOCUS The FOCUS training course provides special knowledge on specific subjects that are not an integral part of the actual business process. This includes subjects such as: - Planning - Reports - Evaluations - System administration The FOCUS courses are intended for schedulers, controllers and IT support personnel. 6

8 PAS-X PAS-X Training Training Partnership with EnteGreat EnteGreat, located in Birmingham (Alabama), is Werum s PAS-X Training partner for North America. EnteGreat personnel certified as PAS-X trainers delivers standard PAS-X BASIC training courses at EnteGreat locations. Please find comprehensive information on EnteGreat s PAS-X TRAINING services, a detailed training agenda and course dates on the EnteGreat PAS-X TRAINING website. Coaching and Support We would be pleased to provide training and workshops also locally at your site. On request, we can assist you with coaches who will support, develop, and coach your team for any length of time. Further individual services may be mutually agreed on at any time. All our trainers and coaches are experienced professionals with expert technical knowledge gained through practical project work and product development tasks. We welcome any questions or comments you may have regarding training, coaching or support. 7

9 PAS-X PAS-X PAS-X Service Desk The PAS-X Service Desk is the central point of contact for all support and service inquiries of our PAS-X customers, and on request it can provide 24/7 round the clock service 365 days a year. The Service Desk operates according to ITIL standards and combines maximum solution competence with short response and solution times. It receives and documents inquiries in a trouble ticket system and monitors and tracks them through to resolution. Benefits of the PAS-X Service Desk The PAS-X Service Desk offers the following scope of services: - 24/7 support (depending on the maintenance agreement concluded by the customer) - Remote analyses via secure connections (SSL, VPN, etc.) as requested by the customer - Single Point of Contact o Central point of contact for all support and service inquiries through all communication channels 8

10 PAS-X PAS-X PAS-X Service Desk - PAS-X o Incident management including - 1st Level Support - 2nd Level Support - Oracle o Incident management including - 1st level support - 2nd level support o Support the integration of Oracle MetaLink o Support in the field of backup and recovery o Assistance with the provision of patches - Escalation management o Range of response- and solution-time options (depending on the terms and conditions of the maintenance agreement concluded by the customer; e.g. 1h response time and 4h solution time) - Use of the Trouble Ticket System Quality Standards for PAS-X Workflows, organizational structures and tools of the Service Desk are based on the defacto standard ITIL. All Service Desk staff members follow standard operating procedures (SOPs). Trouble Ticket System The Service Desk uses a Trouble Ticket System. This system records all support and service inquiries, whether they be received via phone call, electronic mail or fax. This ensures that all customer inquiries will be promptly responded to. The Trouble Ticket System significantly increases the transparency of the support workflows, which means that our customers can get at any time detailed information about the current state of their inquiries. Highly Qualified Staff The PAS-X Service Desk is manned by experienced and well-qualified staff. In close consultation with our customers, Service Desk staff become at a very early stage involved in the preparations of the go-live phase. This ensures a smooth and seamless transition of the project to the maintenance stage. 9

11 PAS-X PAS-X Lifecycle Management We support every stage of your MES solution along its entire lifecycle. We manage the lifecycle of each software solution effectively via version management procedures and an established system that administers Software Change Requests (SCRs). This lifecycle management meets the special requirements that exist in a validated environment requiring a high system availability. We use our software tool ProQuMaS (Project Quality Management System) in our projects to support the software development lifecycle US.1 10