Delivered a complete turnkey PLC batching system for pharmaceutical compounding. The project was comprised of system design and operation sequencing, documentation of equipment design including all drawings, supervision of equipment installation, PLC/HMI configuation and programming, initial testing, and full system deployment.
Developed a custom InTouch – Wonderware HMI application with 50 graphic screens and intergrated the application as part of a plant-wide water injection system. The application performed alarming (of what?), datalogging (of what?) and FDA reporting (of what?). Design and deployment of a new system architecture with multiple servers and an Ethernet connection to the existing TI/Siemens, PLC’s via OPC enabled the integration.
Designed and implemented a system for tracking, recording, and archiving all aspects of the (What Product?) manufacturing process as required by the FDA. Using VB/C#, ASP.NET, and PL/SQL stored procedures, the system tracked batch/lot status, operator inspections, inventory and raw materials usage, rework, and supervisor approvals. The system was compliant with 21 CFR-Part 11 requirements for data encryption, traceability, and electronic signatures.
Designed and developed a system for collecting, organizing and reporting the real-time product locations, process parameters, product genealogy, and inspection & test history of portable vessels used to manufacture and store vaccines. Controlware generated the functional requirements, technical specification, and managed a five person development team utilizing J2EE, Struts, and Hibernate. The data warehouse was build using Oracle in conjunction with Microsoft Analysis and Reporting Services to support ad hoc quries and FDA reporting requirements to verify product integrity.
Designed, developed, and deployed a process management system for a pharmaceutical packaging plant serving 10 users. The system collected, recorded, analyzed and reported on process metrics such as cycle times, equipment downtimes, product quality, and batch release criteria. The application was built on SQLServer using a federated data model utilizing data from SAP, and manufacturing, quality control and laboratory management systems. System services extracted and cleansed data. Analysis services were used to build cubes. Business logic was implemented in .Net (VB/C#), with Business Objects as the graphics front-end.
Defined the requirements, designed, developed, deployed and achieved FDA validation for an automated inspection system for(What type of product?). The system visually inspected product for potential defects, ensured proper weight, and automatically rejected bad product and packaged good product which was labeled and bar-coded. Programming was performed using HMI software and C#.
The system formed a component of Legal Discovery System that scanned and converted printed documents to PDF’s and stored them in a searchable repository where they were indexed for later use. The repository was comprised of individual disparate data stores (Legato, Visisimo, Sharepoint, and shared files). Microsoft WCF (Windows Communication Foundation) was used as a backend framework services to return search queries.
Built a data warehouse created from a federated data model from the databases of non-integrated information systems supporting actuarial, financial, and operational departments which were not previously integrated. The system was constructed with Microsoft’s BI Suite (SIS, SSAS, and Excel). Employing the Kimball methodology, ad hoc reporting was provided by Microsoft Analysis and Reporting Services with customized MDX queries and KPI’s.
Designed, developed, and deployed a secure Commercial Data Exchange enabling the trading of audited billing and accounting data the client’s systems of those of its trading partners. Electronic Bill Pesentment provided invoices in PDF and XML formats enabling trading partners to view, archive, and perform metadata exchanges within their own systems. The system promoted greater collaboration and cooperation between trading partners, reducing errors and processing time while improving cash flow. The facility was built in three-months using Microsoft’s Sharepoint Server with search capability, Windows Communication Foundation, Business Data Catalog, Windows Workflow Foundation, Linq to Sharepoint query services, customized Sharepoint Document Libraries with custom audit trails packaged as features, and single sign-on capability.