Articles

There are many Laboratory Information Management System (LIMS) projects that have collapsed or failed to deliver the expected benefits. In addition many projects are significantly over budget with non-budgeted on-going costs e.g. IT consultants on site for many months after delivery of a system.

Furthermore projects of this nature end up with a changed specification from that originally described.

This paper lists some of the risks and introduces the Autoscribe approach and initiative aimed at reducing these risks.

ICH Q10 is a comprehensive model for a pharmaceutical quality system that can be implemented throughout different stages of a product lifecycle. The aim is to establish and maintain a state of quality control and to facilitate continual improvement. Implementing well defined, integrated processes that work within the culture of the organisation is paramount. Implementing an automated solution can greatly increase the chances of success.

When introducing a new Medical Device onto the market, a number of well-defined risk analysis and evaluation phases should be undertaken. Risk Management and the performance of Risk Assessment are crucial parts of the design, development and control process.

Risk Assessment is a valuable tool and a regulatory expectation that should be used throughout the whole of the product life cycle to ensure a safe and effective product.