When: 10/18/10 - 10/21/10

SMRP (Society of Maintenance & Reliability Professionals) is an independent, not-for-profit, professional society formed by practitioners, for practitioners. SMRP is dedicated to instilling excellence in M&R in all types of manufacturing and service organizations, and in promoting M&R excellence worldwide.

GenesisSolutions will be a sponsoring exhibitor and presenting on “Launching Maintenance Communities of Practice for Reliability Excellence” at this conference.

Please visit us in the exhibit hall at booth #212 and ask for details on our Hospitality Event Tuesday, October 19th at the Miller Time Pub at the Hilton Milwaukee City Center.

When: 08/08/10 - 08/10/10

The Mountain West Maximo Users Group was formed by Maximo users in the Utah and Rocky Mountain region.  We believe we are the only user group that is actually run by users, not vendors, of the software.  We remember what it was like to walk down the aisles at MRO World/Pulse and wonder who should we talk to and who could really help us.  We have spent the last five years learning from the school of hard knocks and attending MRO World/Pulse and various user group meetings to build a network of users and vendors who really know how to help you.  Although we feel like we know how to move around in the Maximo community, we also look forward to meeting new and old users to share successes as well the horror stories.  That is what a user group is all about. 

GenesisSolutions is a sponsor of this conference.

When: 06/07/10 - 06/09/10

ISPE (International Society for Pharmaceutical Engineering) develops innovative professionals globally to achieve technical and operational excellence in the pharmaceutical industry. ISPE’s core purpose is to lead global change and innovation in pharmaceutical technology and processes.

GenesisSolutions is exhibiting at this conference and will be presenting on Maintenance Master Planning at 2:30pm on Tuesday, June 8, 2010.

When: 2/22/10 - 2/25/10

ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association dedicated to educating and advancing pharmaceutical manufacturing professionals and their industry. Founded in 1980, today ISPE serves 25,000 members in 90 countries.

GenesisSolutions will be exhibiting in booth #76 and presenting on Thursday, February 25th (Mr. Mike Greenholtz - Discussing Wyeth Pharmaceutical’s Maintenance Excellence Program).

As part of this effort, GenesisSolutions implemented an advanced RCM program for the injectable vaccine production unit of the Carolina, Puerto Rico plant. Increased month dosage production rates from 3.2M to over 5.0M in 9-months time. In addition, the plant achieved this productivity increase while moving production from three lines to two and achieved associated maintenance and spare parts savings. This is a capacity constrained production unit for a life saving vaccine for infants with a worldwide annual demand of over 60 million dosages.

During the same implementation phase, GenesisSolutions also implemented the same RCM program for the packaging department of the Guayama, Puerto Rico plant resulting in a $240M product throughput increase in the first 4-months of operation. A key part of both programs was the Genesis Reliability Analysis for critical equipment. This approach was based on a Failure Modes and Effects Analysis leading to improved reliability from more proactive and less reactive maintenance, a planning and scheduling partnership between maintenance and operations, better spare parts support and a stronger calibration program.

At both the Carolina and Guayama plants Genesis developed a maintenance planning and scheduling program that includes workflow processes to accomplish annual planning and shutdown planning. An SOP was written, a Planning and Scheduling department created, training conducted for all plant key stakeholders (operations, maintenance and support personnel), in-depth training conducted for plant planner/schedulers and metrics created to track reliability and functional performance. The program was launched using a pilot approach and then deployed plant-wide.

A major pharmaceutical manufacturer needed to upgrade their existing EAM package to a more current release and deploy across 20+ major manufacturing sites.  The main drivers for upgrading to the newer release included upgrading the Oracle infrastructure, limitations with vendor support, and Japanese language support.

Genesis was brought in because of their extensive depth of knowledge with pharmaceutical-related EAMS implementations as well as their ability to staff the project with resources that were very seasoned with diverse skill sets, which allowed the company greater resource efficiencies during the implementation.

Genesis Role

Genesis provided a Principal Consultant as Project Management leadership for the Upgraded Development team, as well as two Principal Consultants for application development, three Consultants for Validation testing, two Principal Consultants to develop tools to shorten deployment time, and two Principal Consultants to manage / execute the deployment of the product upgrade.

Actions Taken

The customer requested the following skills / roles:

• Project Management
• Interface Design and Support
• Validation Testing Management
• Validation Documentation
• Database and Schema Management
• Data Migration Design and Execution
• Product Upgrade SQL Script Development and Execution
• Environment Update Design and Execution
• Application Training for Upgrade and New Sites
• Production Application Support

Results Achieved

Upgraded EAM product was designed and validated on time and within budget.

Upgrade was rolled out to 34 sites, using 2-day weekend outages throughout the year.

Eight sites were taken live on the upgraded version.

A major pharmaceutical manufacturer needed to create an interface to send GMP equipment information from their EAM Maximo system to their ERP SAP system. The primary reasons for creating this interface involved the implementation of key regulatory systems in SAP (CAPA - Corrective Action Preventive Action) that would provide the necessary controls to monitor, track, and approve GMP equipment investigative documentation.Genesis was brought in because of their extensive knowledge of unique pharmaceutical CMMS needs and because of their excellent track record working with companies of similar design.

Genesis Role

Genesis provided a Principal consultant and a System Architect to design, develop, and validate a custom interface from Maximo to SAP using Web Services. The Genesis professionals complemented a team provided by the customer to assist with the validation efforts of the project.

Actions Taken

The customer required that the interface solution be designed using Web Services which was the method available to SAP for communicating with other systems. In addition, the customer was using an older version of Maximo without the Maximo Enterprise Adapter (MEA) components that provide the necessary tools to write interfaces to other systems such as SAP. As a result, the Genesis team was left with the challenge to design a custom solution merging old and new technologies to satisfy the following requirements:

• Validate and transfer specific GMP equipment information out of a Maximo system that was based in older technology
• Store the data in custom interface tables simulating queue processing methodology
• Apply the latest Web Services technology to move the data from Maximo to SAP
• Provide all necessary message processing capabilities to record errors produced because of failure to validate data in Maximo or SAP

Results Achieved

The custom interface was successfully designed, developed, and validated a month before the customer started using the SAP CAPA solution.The solution provided a seamless interface between two systems without changing any of the existing business process in the Maximo side. This added benefit provided considerable savings in time and money.The solution provided increased data integrity to the SAP CAPA system eliminating the need for double entry of the same data in two different systems.Reduced the risk of system non-compliance due to GMP data entered incorrectly in SAP CAPA.

The customer desired to upgrade their Maximo application and replace their legacy calibration systems to enable them to achieve a lower total cost of ownership. The customer also desired a mobile solution to manage their calibration work.

Genesis Role

Genesis provided a project manager experienced in implementing enterprise maintenance applications in the pharmaceutical industry. The project manager was responsible for planning the project timeline and resources. The project team was comprised of both customer resources and Genesis personnel.

Actions Taken

Within 15 months from the time the project plan was built, the team went live with the Maximo application for maintenance and calibration at the first site. Over 20 sites followed over the course of the next 16 months.

Results

Customer was able to save several million dollars annually due to the consolidation of systems and implementation of paperless work orders throughout their calibration and maintenance organizations

Due to FDA regulatory requirements, a major pharmaceutical corporation needed to replace a legacy CMMS application. The primary requirement was that the replacement system must meet FDA 21CFR Part 11 electronic records requirements and serve as the primary Enterprise Asset Management system for all northeastern facilities and manufacturing sites. Secondary goals included harmonizing business processes and procedures throughout the organization. Genesis was selected as the implementation vendor because of its expertise concerning the development and deployment of validated maintenance management systems within the pharmaceutical industry.

Genesis Role

Genesis served in many roles throughout the implementation of the new application. Genesis initiated the project by providing a full site assessment of the current legacy system and provided a gap analysis that must be overcome in order to meet regulatory requirements. Genesis provided resources to manage and complete all aspects of the implementation including product evaluation and selection, business process reengineering, project planning, system design, system development, and deployment. In addition, Genesis managed and performed a data collection, verification, and cleansing effort that included inventory, equipment, spare parts lists, and enhancing preventive maintenance procedures over the major customer campuses.

Actions Taken

• The project was divided into multiple phases that were deployed over multiple years. The primary roles and actions of the project were as follows:
• Evaluate and redefine business processes that are consistent and effective throughout the organization.
• Develop requirements that the selected computer system and business practices must achieve.
• Select the appropriate application to meet the user requirements.
• Document the functionality that supports the user requirements.
• Design and construct the application to meet specifications.
• Test and verify the functionality of the configured application.
• Develop and execute all system validation documentation necessary for a regulated system.
• Physically evaluate and capture specification data for all assets and inventory throughout the deployment sites.
• Perform data standardization for all data for migration into the application.
• Evaluate and improve PM procedures based on industry best-practices and manufacturer recommendations.
• Migrate data into the application.
• Develop system interfaces to multiple secondary applications.
• Develop training material specific to the customer’s business processes and application configuration.
• Provide training to over 700 application users.
• Commission and release application for use.
• Decommission legacy applications.
• Provide system and user support during system release and post deployment.
• Develop computer based training and certification to train resources on business practices, application usage, and eliminate classroom training.

Results Achieved

• Business Processes harmonized
• Fully Validated Computer System meeting all regulatory requirements is in place
• Improved data quality and effectiveness
• Eliminated many manual paper based processes
• Developed business key performance indicators and targets
• Self directed application training
• Successfully retired legacy application

Through an exhausting interviewing process, we partnered with GenesisSolutions.  The implementation team at Genesis invested the time to understand our business processes. They designed a consolidated workflow and implemented the best software solution to meet our needs.  The working relationship with Genesis was truly built on a foundation of trust, formed through superior performance consistency.  The various teams of technical and process specialists successfully helped us through all phases of our business re-engineering, software solution selection, and implementation.  The project was a success and I believe it was due to the outstanding teamwork of the Genesis project teams. We continue to benefit from the years of a cooperative business relationship built on the foundation of trust.”

— Sheila B., Systems Administrator, large pharmaceutical company