By: Sandra K. Rodriguez, Research Associate
14th Werum PAS-X User Group Meeting
It’s hard to image that attending a MES User Group Meeting would make you walk away with the impression that successful MES implementations are not simply about the best technology, but that was the case at Werum’s User Group Meeting (UGM) in Morrisville, NJ on May 12-13, 2016. Rudiger Schlierenkampf, CEO, Werum IT Solution and Benjamin Pieritz, Senior Vice President Operations, Werum IT Solutions, kicked off the meeting by providing a company update and announcing 15 years of success throughout North America.
Clients and prospects gathered to share best practices, success stories and the challenge of automating a historically paper-driven process. Overall, the hot button topics were business process harmonization and cultural change management. While great technology is required, it is not sufficient to ensure a favorable outcome.
TECHNOLOGY IS NOT SUFFICIENT TO ENSURE MES SUCCESS
Software companies are beginning to understand that their products are only as good as the requirements they are built to meet. Input from the user community is critical not only to maintain market share, but to ensure the product is future proof. As life science companies move from point solutions to platforms and streamline their IT operations and consolidate enterprise systems, Werum is working on ensuring the adoptability of their solutions to this new IT landscape.
As our European counterparts are focused on Industrie 4.0, Werum is preparing its customers for Pharma 4.0. This new product /strategy focuses on five areas:
- Regulatory – Global Compliance Requirements and E-Inspections, Quality Metrics
- Performance – Quality Metrics, OEE, KPIs
- Integration – Operator and Equipment Manuals
- Automatic Data Capture – PLC, HMI, DCS, SCADA
- Compliance – Data Integrity, Regulatory Compliance, Knowledge Management
Yet, customer conversations rarely revolved around storage, hardware or device issues. At the core of MES is recipe management which includes materials management, weigh and dispense, process monitoring, quality management and review by exception. Companies who have not implemented an MES are completing these tasks using manual, paper-driven processes. Implementing a system that automates this process is the easy part. Managing the change as an outcome is actually the pain point. As a result, senior management at Pharma and Biotech companies are beginning to pay attention to this new reality.
Compliance is not Sufficient to Ensure Quality Products
Gert Moelgaard, formerly with NNE Pharma, discussed the significant challenges the pharmaceutical industry has been undergoing over the last decade. The presentation took the audience back in time to look at what has happened over the past 10 years in both industry and FDA and what can be expected in the future – especially regarding data and the future of regulatory compliance. This was followed by a presentation by Daniel Matlis, President of Axendia who explained why quality and compliance are not the same and provided an overview of FDA’s Quality Metrics Initiative which shifts the focus from compliance to quality. He also discussed the key role MES plays in supporting Quality Metrics.
Rob Gamber, Sr. Manager – Platform Architecture at Amgen, discussed the company’s journey to the Digital Plant and revealed how it can exist and thrive in a FDA regulated environment. Dr. Marco Klingele, from Losan Pharma, provided the CMO’s point of view with an introduction of electronic batch recording (EBR) in order to eliminate the ever-increasing challenges associated with paper-based documentation. By replacing multiple point solutions into the PAS-X platform and integrating with its ERP, Losan consolidated out-of-the-box functionality. As a result, they will be able to support manufacturing, warehouse management, electronic batch records and track and trace requirements with a single platform.
A panel discussion titled “Lessons Learned from Success: Getting the Most from Your MES” reaffirmed that successfully implementing MES is not just an IT project; rather, it must be led by the business. The message from the previous days’ customer roundtable rang loud and clear:
- Stakeholders need to understand the impact of the project on the business and proactively address change management
- Consider the impact on people when shifting from paper work to knowledge work
- Management sponsorship is critical as is the need for influencers on the shop floor to advocate for the project
- After go-live, continue to work with business champions and focus on continued process improvements and on- going training
With over 100 customers and partners in attendance, the rubber did indeed meet the road in Newark, NJ at Pole Position Raceway, where participants experienced speed, safety and compliance. To showcase its ease of use, Werum also used the PAS-X product in real-time both at the hotel during a coffee break and at the raceway where attendees were able to order drinks via the PAS-X mobile user interface on a tablet.
While using the latest technology and complying with regulatory requirements is a baseline, getting the most from MES requires: managing change, culture and people.
The opinions and analysis expressed in this article reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this document is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This document is not intended to endorse any company or product and should not be attributed as such.
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