An integrated platform for the development and management of statistical software at Roche Diagnostics

Roche delivers products and services for the prevention, diagnosis and therapy of diseases to scientists, doctors, patients, hospitals and laboratories throughout the world, and is the market-leader in the field of In-vitro Diagnostics.

The Heidelberg-based software company, HMS Analytical Software GmbH, together with the manufacturer of medical devices, Roche Diagnostics GmbH, have jointly developed an innovative server platform within the medical industry that not only meets the demands of production processes of larger medical technology manufacturers, but also fulfills the requirements for validated systems as set by the regulatory authorities.

Colibri: All requirements under one roof

The platform “Colibri“ (Code Libraries) manages statistical software for the development and production of medical devices. It is the first platform of its kind that brings the central requirements of the pharmaceutical and medical technology industries under one roof, that is, the administration of the already validated statistical software (SAS Institute) necessary for the tests, the management of large amounts of data and, moreover, the usage as a building block for applications that support the production. Within this building block, a number of fully programmed statistical functions, which can be used for applications with varying requirements, are placed at disposal.

The rationale behind the development of Colibri was the continuous increase in the volume of data, as well as the requirements of the Food and Drug Administration (FDA) pertaining to the validity and traceability of all IT processes. The development of Colibri demanded professional project management – at times up to 30 specialists from both companies, Roche diagnostics GmbH and HMS Analytical Software, were involved.

Flexible and Extendable

Colibri is so flexible, that it allows the main tasks to be performed parallel to each other: support for the production (for example, the computation of codes for test strips and calculations for other test carriers), tests and validation of new functions and further development of the system (for example, the programming of additional statistical algorithms) as well as the administration of statistical software (Versions, access privileges). Currently, the platform consists principally of 40 packages, each of which consists of a collection of functions for a particular theme. Depending on the theme, a package can comprise up to 20 diverse functions. The functions are accessible in so called Workspaces in neatly arranged Web interfaces.

Even by ever increasing demands on the volume of data, validation and administration, Colibri can be used and adapted time and again. The same applies for the applications: the software functions can be adapted and extended for the production of widely diverse device types. Moreover, Colibri offers a number of administrative functions (access privileges, versions), that simplify and partly alleviate administrators of these tasks. In the long term, this platform should make all processes and data across the individual development and production divisions consistent and comparable.