Compliance - Case Studies

ERP Application Validation

Our personnel worked on both the technical and client side of an effort to validate the BPCS ERP software. Some as employees and some as contractors, we provided critical project management and technical developers to remedy and implement a validated version of BPCS as a by-product of the Y2K upgrade effort. The project required the coordination of multiple sites that were geographically separated but electronically linked. Innovatum personnel were heavily involved in:

• Software assessment and selection
• Code correction
• Project management
• Project 'marketing' and communication
• Validation program development
• Test documentation
• Test training
• Test coordination
• Implementation activities
• Validation closeout tasks

ROPICS Barcode Solution

The ROPICS barcode data collection system was developed and implemented as a tool for real-time data collection into a validated ERP system. Building on a validated system, this new functionality was required to be validated as well. This software which is used to communicate transactional data into the backbone ERP package needed to be designed, built, tested, and implemented in a way that would satisfy the requirements of systems validation in order to be approved for use. For example, security needed to be implemented such that users were able to access the system for their particular business processes and nothing more. Additionally, the portable computers' security needed to behave in the same manner as a desktop with such features as automatic sign off.

The quality program included a validation plan IQ/OQ/PQ protocols, and complete IQ/OQ/PQ documented testing process. Tasks such as personnel training needed to be formalized and documented. Procedures were created and or revised, and all users trained prior to roll out. The implementation plan required 24 x 7 coverage.

ROPICS Weigh

ROPICS Weigh is a manufacturing execution system (MES) designed for real-time batch record data collection in a pharmaceutical environment. This system was built implemented, and is supported by Innovatum personnel. This system takes into consideration the need for bill of material (BOM) accuracy and prior written approval of the BOM by Quality, using electronic signatures and electronic records (21 CFR Part 11). The shop order release process needed to consider the status of the BOM to protect against the use of an inaccurate recipe. It is necessary to review and approve raw material lot data electronically so that weighing calculations could be managed by the system.

Here again, the combined technical, business, and industry knowledge of Innovatum personnel was critical to the project's success. Today Bristol-Myers Squibb uses ROPICS and ROPICS Weigh in order to streamline and automate their manufacturing activities.