ALARIS Medical Systems - Intelligent Infusion Systems

Situation

As ALARIS develops increasingly powerful intelligent infusion systems for their hospital clients, the documentation requirements for these systems has changed. In addition to the clinical and biomedical technician audiences they previously addressed, the new systems require the involvement of the hospital IT department to implement the LAN and Wireless networking they require.

FDA Approved Documentation

The suite of documents we developed addresses all of the internal and external audiences. Each document is tailored to the audience in terms of experience and subject matter, and all of the documents emphasize clear procedures and generous illustration to make them as usable as possible. The FDA approval required for these docuemnts places an additional burden on proofing and review to make sure that each procedure is accurate and replicable.

Implementation Planning

Two Implementation Plans were developed - one for New Installations, and one for Upgrades. Field and Technical Support staff were involved in the entire development process, which was Flowchart and Checklist based.

Knowledge Management

In focused meetings with stakeholders from Marketing, Support, and Field Service, we developed a series of process maps to define the requirements for implementing the new software, and the accountable groups within the company or its customers for each required action. We also defined the training, documentation, and other tools necessary for them to complete their new tasks.