Bristol-Myers Squibb's Paula Mastrangelo, associate director of clinical supply operations, offers the following tips on selecting an electronic solution for batch execution and disposition:
• Develop a solid project framework with a team of global members made up of professionals from quality assurance, technical experts, and project leaders for technical and business sides.
• Develop user requirements and project scope documents, and a project plan.
• Develop an approach with prototypes to be evaluated from all sites to allow feedback.
• Identify resource requirements, risks, and finalized budgets.
Lessons learned to improve the next program
• Maintain communication throughout the project with all involved.
• Don't underestimate time and resource requirements for system and user acceptance testing, relations with vendors, and hands-on training.
• Spend sufficient time and resources upfront.
Benefits of a successful plan:
• Reduces execution and documentation errors.
• Allows review of batch record entries immediately.
• Reduces cycle time by not passing paper records.
• Permits more efficient use of labor and equipment.
• Offers more standardized guidelines.
Mastrangelo presented these findings at the recent ISPE (Intl. Society for Pharmaceutical Engineering) conference in October 2004.
