PROJECTS
ABSTRACT 1: BUSINESS PROCESS UPGRADE
Summary:
Analyzed and developed user requirements to select an MRP package for a Pilot Manufacturing facility for a major pharmaceutical company. Developed system functional requirements from written user requirements augmented by interviews with management, key users and client Information Management personnel. Surveyed available appropriate software packages, interviewed vendor representatives, coordinated vendor demonstration and wrote recommendation based on business (process, cost and cost of operation) and technical (integration into existing environment, vendor technical support) factors, and conformance with applicable corporate standards.
Detail
Engaged to select and implement a manufacturing resource planning (MRP) system for a Pilot Manufacturing facility at Bristol-Myers Squibb (BMS), and meet an accelerated time schedule imposed by Y2K considerations. AA involvement included the following:
Determine Requirements
Analyzed operations and developed user requirements. Elicited system requirements from existing user documentation, interviews with key users, management and Information Management (IM) personnel.
Vendor Evaluation and Selection
Surveyed available appropriate software packages, interviewed vendor representatives, coordinated vendor demonstrations and developed system recommendation.
Recommendation
Recommendation was based on business (process, cost and cost of operation) and technical (integration into existing environment, vendor technical support) factors and conformance with applicable corporate standards.
Implementation
System was installed and customized by a team of vendor consultants, BMS users and AA. AA wrote retirement plan for the system being replaced and migrated data from it to the new system.
Validation
AA was responsible for validation. Wrote Validation Plan, IQ/OQ/PQ protocols, participated in validation testing and wrote reports.
ABSTRACT 2: MANUFACTURING OPERATIONS SUPPORT
Summary
Acted as outsourcing contractor responsible for support of MRP, Purchasing, Inventory Control and Material Accounting application systems for an OTC division of a major Pharmaceutical company manufacturing operation.
Detail
Artech Associates was the outsourcing contractor responsible for support of MRP, Purchasing, Inventory Control and Material Accounting application systems for a Bristol-Myers Squibb (BMS) Products division manufacturing operation. Support team consisted of two systems analysts and one engagement manager. Responsibilities included day-to-day support; monthly communications meetings between plant management, users and BMS Information Management.
ABSTRACT 3: OPERATIONS ANALYSIS
AA was engaged to perform a study of existing information systems and processes for a Pharmaceutical manufacturing facility in Morrisville, NC. Modeled current processes by analyzing the use of existing legacy systems and interviews with key users and plant management. Interviewed plant management to determine objectives for plant operation support systems. Presented object model of systems and processes to the plant manager, Information Management group responsible for plant information systems, and other members of plant management team.
The study was commissioned to explore improving processes through closer integration of stand-alone operations support computer systems. The processes and associated systems studied included Forecasting, Finite-Capacity Scheduling, Laboratory Information Management System (LIMS), MRP, Material Control and Accounting, Purchasing and a plant floor bar- code interface Inventory Management system.
ABSTRACT 4: Y2K ANALYSIS
AA was engaged prepare Y2K solution plans for portfolio of manufacturing operations, accounting and laboratory information systems. Analysis included studying date sensitivities, system interfaces and operating system Y2K readiness. Presented plans and cost estimates to plant management, BMS Information Management and corporate Y2K project team. The studies were basis for decision to replace the systems rather than remediate them.
ABSTRACT 5: PROJECT MANAGEMENT
AA led a team in specifying, selecting and implementing a Finite Capacity Scheduling system for a pharmaceutical manufacturing operation. Elicited requirements from plant management and scheduling staff. Authored functional requirements and system specification documents. Issued Request for Proposals to selected vendors, evaluated proposals and participated with client in system selection process. Customized workstation functionality and X-Windows user interface, integrated with Unix server into existing Novell PC LAN environment and mainframe systems. The system was integrated into plant operation workflow and interfaced with mainframe legacy systems. Trained schedulers and manufacturing users in system operation and administration.
ABSTRACT 6: VALIDATION
AA managed and coordinated Installation Qualification and Operational Qualification validation efforts, developed protocols and performed the Performance Qualification, and published the complete validation document set for a LIMS in a large pharmaceutical manufacturing facility. Data migration from other systems and from print documents was managed and validated by AA. The validation approach was used as a template for other implementations in this major pharmaceutical company.
In addition, AA was a key participant in all phases of this LIMS implementation project for a large pharmaceutical manufacturing facility, including the following:
- Requirements Definition and Management: AA participated in defining system requirements. Requirements were elicited in interviews and meetings with key personnel, analyzed for completeness and compatibility with other requirements, and compiled into a Requirements Specification document. AA was a participant in this project phase.
- Vendor and System Selection: AA participated in the process of surveying potential vendors and systems and in the final system selection.
- Implementation: AA participated in system implementation, customizing and otherwise adapting the system to integrate with other corporate data systems, support the plant operations, and modifying SOP's to incorporate the system and increased level of automation into the workflow.
ABSTRACT 7: VALIDATION OF SAP BOLT-ON SYSTEMS
AA has participated in validation efforts for SAP bolt-on systems including LIMS and various material management subsystems incorporating barcode technology and interfacing with weighing and other systems. In most of these engagements AA wrote validation plans, developed protocols and performed the qualification testing with client witnesses. These projects were sometimes completed entirely by AA personnel, sometimes by teams comprised of AA and client personnel.
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