Bringing Safe and Cost Effective Products to Market

Transcription

1 Industry Solutions Life Sciences Engineering, Project Collaboration, Document Control and Facilities Management Solutions across the Life Sciences Value Chain Industry Solutions

2 Life sciences companies who have a grasp on their value chain and are able to coordinate activities across the value chain will be able to unlock a competitive and strategic advantage. Deloitte Consulting Integrated Document Management along the Life Sciences Industry Value Chain, 2011 Bringing Safe and Cost Effective Products to Market Life Sciences companies face a wide variety of challenges. These include growing regulatory requirements in both manufacturing operations and clinical trial processes and the importance of documenting Good Manufacturing Practices (GMP). There is also the need for increased collaboration at different stages of the drug development lifecycle and pressures to shorten time to market. Few industries also face such rigorous monitoring of documentation. In the US, for example, the Food and Drug Administration s (FDA) 21 CFR Part 11 regulations require Life Sciences companies to implement specific audit trails, electronic signatures, strict access control and storage for all documentation. The adherence to GMP has also become a mandatory aspect of pharmaceutical manufacturing in many parts of the world. The World Health Organization (WHO) has a version of GMP used by pharmaceutical regulators in over 100 countries and the US FDA and European Union have similar GMP requirements. Against this backdrop, there is a need for Life Sciences companies to coordinate activities across the value chain and bring safe drugs and medical devices to market as quickly and as cost effectively as possible. Companies must be able to manage multiple stakeholders, multiple documents and increasingly complex projects while delivering accurate documentation that demonstrates correct manufacturing practices and product integrity. Get it right, and companies can look forward to sustained success. Get it wrong, and the regulator and significant commercial penalties await. industry & document control experience McLaren Software Coordinating the Life Sciences Value Chain Whether relating to Research and Development, patents, clinical trials, major capital projects, manufacturing or distribution, McLaren Software is ideally suited to meeting the needs of the Life Sciences sectors. McLaren Software s industry leading engineering, project collaboration, document control and facilities management solutions are helping Life Sciences companies meet regulatory requirements, optimize manufacturing and healthcare facilities, and bring safe drugs, medical devices and healthcare to market on time and on budget. McLaren Software s solutions: Support the design, construction and operations and maintenance of major capital projects in the life sciences and healthcare sectors throughout the project lifecycle. Ensure that all Life Sciences companies meet regulatory requirements, such as 21 CFR Part 11, through documentary evidence and transparent audit trails. Support Life Sciences companies in complying with and providing evidence of GMP guidelines to regulators throughout the manufacturing process. Help Life Sciences companies develop specific Standard Operating Procedures (SOPs) for document management and support the distribution of these throughout organizations. Support healthcare providers in their healthcare facilities management activities covering all building design and building services activities. Whatever the challenge or requirements, McLaren Software is meeting the increasingly complex demands of the Life Sciences sector today. The value chain is a chain of activities that a firm operating in a specific industry performs in order to deliver something valuable. Michael Porter Competitive Advantage: Creating and Sustaining Superior Performance

3 An End-to-End Solution 50,000 Documents Managed and Over US$1 Million Saved A leading Cancer Research Center used McLaren software to manage its documents, drawings and associated change control for over 100 buildings at its R&D campus. All buildings and 50,000 documents and drawings needed to be reviewed and validated according to FDA requirements. McLaren solutions managed all documentation, including base plans (reference files), loop diagrams and drawings. Over $1 million was saved annually on re-survey costs and compliance was achieved with FDA regulations. Helping a Biomedicines Company Coordinate Its Manufacturing Process A leading manufacturing biomedicines company used McLaren to manage its engineering documents, drawings and change control processes within its manufacturing facilities. Business processes were harmonized across sites and watermarks incorporated to minimize the risk of outdated documents. The result has been a significant reduction in open work orders and the risk of non-compliance, an improved ability to respond to audit requests, automatic audit trail generation and reduced data entry errors. McLaren - Delivering Healthcare Projects on Time and On Budget Life Sciences is one of the fastest growing sectors. Biotherapeutic, biopharmaceutical, biomedicines, healthcare and pharmaceutical companies look to McLaren Software solutions to help manage plants, facilities, manufacturing supply chains and engineering projects. Central to this is the concept of lifecycle asset management. McLaren s engineering, project collaboration, document control and facilities management solutions will coordinate all stages of the Life Sciences value chain. At the design, procurement and construction phase of a healthcare facility, for example, McLaren solutions accelerate project execution, reduce re-work and help deliver projects on time and on budget. Bringing new and innovative drugs to market requires agile engineering departments that can build, re-configure and refurbish plants prior to launching production of a new medical device or product. Again, McLaren s document control solutions can provide up to date and real-time documentation in advance of live operations. At the handover, commission and start-up phases, McLaren solutions ensure the seamless exchanging, reviewing and updating of engineering and project information, the adherence to GMP practices, the establishment of effective Standard Operating Procedures (SOPs) and the reducing of time to market. At the production and manufacturing stages, McLaren solutions minimize operating costs, reduce risk and lost production, and ensure all regulatory and safety requirements are met in the pursuit of bringing safe drugs and medical devices to market. The construction of a Birmingham hospital in the UK. The development of a Children s Hospital Development in Dublin, Ireland. A new Medical Technological Centre in Marseilles, France. Decommission / Restoration Operate Asset Planning Concept / Pre-FEED Engineering Select EPC FEED Detailed Design EPC Contractors Procure Turnaround Operations Maintain Custody Transfer / Handover Commission & Start-up A&E Firms Construct A Complete Solution across the Asset Lifecycle

4 McLaren Software Solutions Whatever the challenge in today s Life Sciences sector, McLaren Software s solutions, consultancy and partnership capabilities have the answer. It is important to have audit trails, or other physical, logical, or procedural security measures in place to ensure trustworthiness and reliability of the records. 21 CFR Part 11 Procedures, US Food and Drug Administration Modular Solutions across the Asset Lifecycle McLaren s engineering, document management and control solutions support all Life Sciences lifecycle phases. Its modular applications software suite covers drawings, audit trails, reporting, transmittals, handover, and operations and maintenance. A Comprehensive Audit Trail across Manufacturing McLaren s solutions ensure complete visibility and a comprehensive audit trail across the manufacturing supply chain, addressing the key questions of - who did what, when and why? With features such as personal dashboards, automated document numbering, automatic file name recognition, and document delivery scheduling, all procedures can be documented, changes validated, and accurate, real-time records generated to demonstrate adherence to GMP requirements. Meeting Regulatory Documentation Requirements McLaren s software solutions are customized to meet 21 CFR Part 11 and other regulations and to safeguard document integrity. McLaren s enterprise scale engineering document management, control and project collaboration solutions come with strict user authentication, security access, record retention and revision processes, allowing regulators to view the traceability of changes and all auditing records. Harnessing the Benefits of the Cloud McLaren solutions are ideally suited to Life Sciences companies looking to collaborate securely and seamlessly with suppliers, contractors, regulators and other external parties in the cloud. McLaren also provides a privately hosted option that leverages the cloud but integrates with internal interdepartmental processes. Delivering Healthcare Projects on Time and on Budget McLaren Software has an unrivalled track record in supporting large-scale health construction projects, delivering direct cost savings and improved operational efficiencies throughout the construction process. The standardization of document control processes provides project teams and managers with a consistent and realtime view of their healthcare portfolio and cloud-based collaboration ensures a seamless interaction with external suppliers. Tracking Data and Documents The tracking of data in the Life Sciences sector is every bit as important as the tracking of documents. McLaren delivers a complete engineering workflow that supports the control of data throughout project handover as well as ensuring data integrity at all asset lifecycle stages. Managing Healthcare Facilities McLaren provides document control solutions throughout the lifecycle of a healthcare facility - covering everything from building design (refurbishment and structural engineering) through to building services, such as utilities, mechanical and electrical and energy conservation. Engineering drawings, such as floor plans, topography, revision orders and photos, are continually updated and documentation seamlessly transferred across countries, language barriers and project teams. Full Consultancy Expertise Through business process reviews, recommendations, detailed solutions designs and work breakdown structures, McLaren Software s consultancy expertise will ensure all Life Sciences projects are delivered to the highest standards. McLaren also provides Information Management outsourcing services to perform business process using McLaren technology, people and processes. McLaren Software solutions deliver: Consistent and auditable business processes. Increased scalability, reduced costs. Built-in flexibility and configuration. Accessible and secure solutions. Full integration. Configurable templates and work breakdown structures. Predefined and configurable reporting. 300,000 users 15,000 capital projects 50 countries Partnership with Technology Leaders (EMC, IBM, Microsoft, Oracle) Partnering With the Best McLaren Software is only as successful as its technology partners. It s through these partnerships that customer investments and roadmap and product compatibility are guaranteed. Current McLaren technology partners include Autodesk, EMC, IBM, Microsoft and Oracle.

5 McLaren Software, part of the Idox Group, is a leading provider of engineering document control and project collaboration solutions supporting all lifecycle phases of operational assets, buildings and facilities. Our customers are leading companies in asset intensive industries including Oil & Gas, life sciences, process manufacturing, construction industries and the built environment. Founded in 1995 McLaren helps owner operators, EPC contractors, construction companies and facility operators execute safe, efficient, compliant projects and operations in all five continents. McLaren solutions are available On-Premise or as SaaS or Privately hosted solutions supported by the McLaren OnAir cloud infrastructure with data centers in the USA, UK and UAE. For more information us at info@mclarensoftware.com or visit our website McLaren Software Houston, USA (Head Office) Regional Offices in: Richmond Avenue Suite 825 Houston, Texas USA Tel Fax London, UK (Idox Head Office) Tel Paris, France Tel Perth, Australia Tel Frankfurt, Germany Tel Pune, India Tel Glasgow, UK Tel San Francisco, USA Tel Idox plc. Ideas, solutions, suggestions, hints and procedures from this document are the intellectual property of Idox plc and thus protected by copyright. They may not be reproduced, transmitted to third parties or used in any form for commercial purposes without the express permission of Idox group. McLaren Technology Partners