 Acute care biopharma manufacturing
RoviSys was selected to provide the data collection and electronic batch reporting system for a new state-of-the-art facility for an acute care biopharmaceutical company. The electronic batch records were developed using OSIsoft RtReports providing 21 CFR 11 compliant reports with all data collection through a PI historian. This was one of the first deployments of these technologies.
Subject matter expert for major pharmaceutical manufacturer
RoviSys provided world-wide subject matter expertise for a major pharmaceutical manufacturer and led the deployment team for a system to collect process and batch data for multi-variant analysis bringing data from the disparate systems in one user interface. RoviSys developed the system architecture, strategy and implementation plan for a roll out to all bulk manufacturing sites throughout the world.
Product tracking for skin care products manufacturer
RoviSys provided a product tracking system for a large producer of hygiene and skin care products. Scope included development of a user requirements specification as well as an evaluation of available technologies fit for use. Since best-in-class technologies were deployed for the functions required and legacy business system needs were present, RoviSys also provided the complete integration for a turnkey tracking system combining order information and real-time manufacturing information.
Asset optimization for wound management
RoviSys implemented a turnkey asset optimization solution for a major acute wound management manufacturer. The system monitored all plant manufacturing assets to report on utilization. All asset events were captured and reason codes were assigned automatically or through operator interaction to identify key problems through Pareto Analysis.
Exception reporting for nutrition
RoviSys was selected to provide an integrated solution to receive process order information and key process variables with quality parameters to monitor for exception during the manufacturing of nutritional products for a state-of-the-art paperless facility. The system identifies abnormal operating conditions with respect to quality attributes and provides exceptions to the batch record real-time.
Global operational management system
RoviSys was selected for the implementation a global operational management solution for a major food manufacturer. The system monitors a number of production statistics from each of the manufacturing sites to ensure that products are manufactured as planned. Actual versus plan information is updated four times per hour providing a real-time view into operations. The system also combines sources of loss, including downtime, performance efficiency and rate of quality, with cost information from SAP to provide management with a real-time view of cost associated with manufacturing losses. The system solution uses existing Allen-Bradley controls, OSIsoft PI, SAP R/3 and SAP .NET connector and Microsoft technologies including SQL Server, ASP.NET and VB.NET.
Compliance software testing and validation
RoviSys was selected to provide the functional testing and validation for the deployment of DMI Compliance Suite 2005 for a mammalian cell culture-based biopharmaceuticals manufacturer. Scope included project management, project plan and quality plan for the testing and validation phase of the project, training on all DMI modules, functional test protocol development and execution, deviation tracking and resolution, IQ and OQ protocol development and execution, development of validation summary packages and traceability from user requirements to qualification tests.
Enterprise change management
RoviSys has been selected on several projects to evaluate, configure and implement automated change management systems for pharmaceutical manufacturers. The systems implemented track and coordinate all plant floor control changes. The systems provide version control, audit trails, security, scheduling and reporting. GE Fanuc Proficy Change Management, MDT Software, and RSMACC were deployed for these applications.
Asset measurement and product genealogy for cosmetic manufacturer
RoviSys designed and implemented a turnkey system to measure production against plan, track downtime, assign reason codes and mark consumer products via UV code for tracking and genealogy. The system interfaced to an Oracle business system for schedule information and leveraged Allen-Bradley PLCs for plant floor information and control. Bar code labels were generated for cases and pallets based on UV codes on containers. The UV codes were generated to allow for identification by bottle case, and pallet after product was shipped, enabling genealogy tracking from warehouse to retail shelf. The system also tracked production against plan in real-time while capturing downtime instances automatically with downtime reason required via bar code. |
