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
Systems & Technology Services: Major Pharmaceutical Manufacturer
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
Results Achieved