Intercim - Operational Excellence for All

Pertinence Suite delivers a complete package (scale up, manufacturing), ready-to-execute process that integrates out-of-the-box current information systems, will help to ensure a successful product launch.

When starting phase II, Process Engineering Teams in charge of process development for a particularly complex bio-chemical entity are faced to many critical process attributes to understand. Located in different sites, the challenge of process specialists and manufacturing resources is to maintain a consistent process understanding and transfer it to manufacturing but also ensure high and steady quality during product launch.

Designed for process specialists, Intercim Process Planning allows Development teams to begin the design process much earlier and with greater flexibility. At any time, experiments or small batches from different sites may be requested with complete confidence that the system is utilizing the most current design. While experiments are conducted, chemists or small scale manufacturing teams can read all instructions and record necessary process data via the web. To ease the analysis effort, process information is recorded electronically and centralized in a single database.

Upon experiment completion, Process Rules Discovery uses historical facts and prior knowledge to analyze process behavior, formalize design space, propose process improvements or control strategy. The entire team constantly shares real time process knowledge through the Pertinence Suite web portal.

A recent product launch is quickly becoming a worldwide success and production capacity is quickly running short. Historical process performance issues are known on older drugs (variable cycle times and yields) due to a production transfer upstream or undetected minor changes and reliable due to an heterogeneous information system that takes unexpected time and effort to fix quality issues. Then, to find capacity, it is important to know how to optimize the current production process and how to put operations under tighter control.

For Manufacturing Operations and IT Team, Intercim's Pertinence Suite provides instant visibility into the entire operation. Centralized batch information in the Velocity Core server data warehouse provides the right users with the right data. Batch information can be collected from equipment, MES, LIMS or SAP without any change on the shop floor and, consistent with regulatory compliance best practices, stored in the core database. The Process Execution module eliminates paper on the shop floor, dispatches electronic work instructions, collects shop floor information and synchronizes the manufacturing process. This modular and scalable approach allows customers to progressively standardize manufacturing systems and procedures and reduce information system TCO.

Based on a structured information system, Operations Advisor Dashboard delivers real-time visibility on the shop floor, informs users where production issues are and offers fact based recommendations. Electronic batch records are saved into the Performance Tracker data store module, reducing time and effort needed to conduct annual product reviews or other audits.

Quality-related production issues have recently appeared in dozens of legacy products. Deviations are more frequent and difficult to handle, creating unacceptable delays. Assuming it is due to a production transfer upstream or undetected minor change (raw materials, operation condition), the challenge is to optimize deviation management and help manufacturing understand the root causes for deviations and fix them.

Pertinence Suite's Emergent Process Management module streamlines the long and tedious process of managing and documenting deviations. Using EPM, deviations are tracked more easily and closed more rapidly. When a deviation is detected, EPM enables manufacturing or QC users to create an "emergent process document" that will generate and dispatch all necessary actions such as additional tests, decisions or comments. For each task, relevant information is collected from an easy-to-use web interface, tracked in the core database and compiled into deviation reports. Key stakeholders like QC, QA, manufacturing management and process specialists will have better visibility on existing issues, develop their understanding of the process and find opportunities to improve process control.

Batch records are saved into Performance Tracker data store module, reducing time and effort required to conduct annual product reviews or any other audit. For example, each product manufactured in the last 12 months can be immediately available in a "12-month product review" to comply with government or industry regulations.