Case Study: Validation Process Efficiency and Cost Reduction Improvements

Transcription

1 Published on IVT Network ( Case Study: Validation Process Efficiency and Cost Reduction Improvements Implementing an efficient, cost effective and innovative Validation Lifecycle Management Systems (VLMS) program at a mid-size Pharmaceutical company. Transforming the validation process from an inefficient paper based to an electronic Validation Lifecycle Management System (VMLS). Page 1 of 7

2 Contents Case Study: Validation Process Efficiency and Cost Reduction Improvements... 1 Executive Summary:... 3 About the Company:... 3 Background:... 4 Solution Assessment and Selection:... 5 Implementation:... 5 Results - Benefits Realized:... 6 Recommendations:... 7 Conclusion:... 7 About the Authors:... 7 Page 2 of 7

3 Executive Summary: A leading and innovative Pharmaceutical company, responded to the business and compliance needs to consistently manage the development, routing, review, and approval of validation lifecycle documents across the organization. The company identified the following drivers for the implementation of a VLMS system: Compliance issues Documentation errors Delays Eliminate paper in the validation lifecycle process Storage space for all the paper documents generated during a validation lifecycle process Traceability, managing and accessing validation documents generated during a validation lifecycle After going live in 2013, they have experienced significant efficiency, cost reduction and compliance improvements in their ability to: manage their validation activities, address compliance challenges, reduce cost, cycle times and increase productivity. This case study describes the implementation and the benefits of implementing an electronic paperless Validation Lifecycle Management System. About the Company: The company was founded in late 1990 s and is a pioneer and leader in offering innovative therapies that transform patients lives. The company have over 350 employees with approximately 100 ValGenesis users. Page 3 of 7

4 Background: Validation regulatory requirements have been in place for the Pharmaceutical industry for more over 30 years. However, complying with validation requirements can be very challenging when the process is paper-based due to the inability to manage, track and execute validation activities consistently. The company prior to 2013 established a paper based validation process for most validation types (process, cleaning, equipment, facilities). However, prior to 2013 the company identified the need for moving away from paper and implementing an electronic VLMS system. The company is a technology oriented focused throughout all its operations. The company leadership identified the opportunity to implement an efficient validation lifecycle process and in the process moving away from the inefficiencies and compliance risk found in traditional paperbased validation processes. The following goals were defined by the company: Develop and implement a lean, compliance, cost efficient electronic validation process Eliminate the inefficiencies found in the traditional paper based validation process Implement a system that enables electronic execution Reduce and eliminate Good Documentation Practices errors Eliminate the risk losing validation documentation and records Implement an efficient validation document review and approval process Implement a system that enables efficient dynamic traceability matrix Implement an electronic validation system that enables an integrated repository of validation document and records Implement an electronic system that enables the ability to provide real time validation status for all systems Page 4 of 7

5 Solution Assessment and Selection: The company vendor selection process required the evaluation of three VLMS systems against their requirements using a Request For Proposal (RFP) process. After the completion of the RFP process and related evaluation of the leading VLMS system in the market, the ValGenesis application was selected. This decision was based on the selection criteria scoring: Ability to meet requirements Usability Ability to expand system usage based on business needs Ability to support help desk tickets according to business needs Accessibility of the support team to support company needs Based on the criteria s above the company identified that ValGenesis met the requirements for a VLMS system. Implementation: To enable a successful implementation the company secured senior management support. Stakeholder inclusion was enabled from project initiation, during implementation and close-out. ValGenesis VLMS was installed and validated within two months. The company validation process was configured on the ValGenesis VLMS platform and Performance Qualification completed within the two-month timeframe. In summary, the entire validation process was implemented in ValGenesis optimized in an efficient cost effective paperless validation process. The company communicated that vendor support throughout the implementation was excellent and was a key factor for the project meeting its aggressive schedule. Page 5 of 7

6 Results - Benefits Realized: The electronic VLMS system, went live in The company achieved the following benefits as a result of the ValGenesis implementation: Paperless solution for their validation processes Reduction in compliance issues or investigation due to the control during the execution Improvement of the validation management life cycle by delivering of projects on-time or less time within budget Enables virtual collaboration, visibility, accountability, time savings through simultaneous review and approval of validation documents Enables notifications and task alerts routed through Electronic workflows supported by automatic audit trails and electronic signatures Improvement of the project resources time utilization The main benefit of implementing ValGenesis was increased compliance, cost and cycle time reductions. Page 6 of 7

7 Recommendations: The successful implementation of an electronic VLMS system was highly influenced by the following factors: 1. Senior management support 2. Robust organizational change management 3. Vision and common organizational goals 4. Robust communication plan Conclusion: The company VLMS implementation have made significant improvements in their validation process by enabling compliance with regulatory requirements, consistency across the entire organization, efficiency improvements and cost reduction. About the Authors: Ivan Soto is the Director Client Engagement and Product Strategy, he is responsible for managing the product lifecycle, strategy and overall client experience. Ivan Soto has been in the industry for over 20 years, and held several technical and management positions at different Pharmaceuticals companies in the areas of Validation, IT Compliance, Quality Control and Quality Assurance. In his previous roles under his leadership, his team successfully implemented a lean validation program. Page 7 of 7