Stratus Technologies, Inc. has launched an availability solutions practice targeted at manufacturing operations of life sciences companies. Named the Stratus CA (continuous availability) Framework(tm), it is a unified portfolio of comprehensive services and products that will reduce the complexity, cost and risk of deploying and maintaining operational continuity in highly regulated manufacturing environments. The practice addresses pharmaceutical producers' requirements for continuous processing and systems availability across the breadth of plant-level production information systems, throughout all phases of their operational lifecycles.
The Stratus CA Framework builds upon two decades of product and system-maintenance excellence in support of mission-critical applications, including operations in nine of the ten largest pharmaceutical companies in the world. Stratus' expanded focus on solutions brings its availability expertise to bear on the entire manufacturing IT infrastructure including servers, networking, security, storage, operating systems, middleware, etc. A combination of infrastructure "hardening" techniques, workflow flexibility, incident management, and automated monitoring, alerting and change control methodologies help assure production continuity, as well as CSV and Part 11 reporting integrity.
Stratus has completed operations-availability assessments at several plants run by top-tier pharmaceutical producers worldwide.
The Stratus CA Framework delivers a range of custom-designed solutions for individual life sciences manufacturers within these three solution areas:
- Infrastructure Integrity - Assuring that the appropriate environment components, configurations, and processes are in place for continuously available operations, even through disruption, disaster, or individual component end-of-life.
- Performance Assurance - Implementation of monitoring, alerting, incident, and problem resolution services and on-demand computing capabilities to assure operation of all components within identified constraints, with intelligence to support infrastructure growth and prevent anomalous conditions.
- Lifecycle Management - Structuring of integrated change-control and IT management processes, support services, and adjunct storage capabilities to maintain the environment (including applications) over its functional life and the on-going life of the information it produces.
Stratus is focusing its availability services on life sciences companies because of the industry's acute need at this time, as it begins to wrestle with migration to electronic batch record systems from manual processes, intensifying regulatory scrutiny, assuring product quality, and improving productivity and financial performance.
"The productivity and cost reduction benefits of computerising processes and record keeping are compelling, but the associated risk of fully integrating all production and regulatory compliance data must not be underestimated, as the industry is quickly learning," said David Femia, Stratus director of the Life Sciences Practice.
"Customers in the life sciences require solutions to large, complex issues in the production environment. Plant operators face intractable demands from management, regulatory bodies and shareholders, among others, that go far beyond what can be solved by a particular application suite running on a server, regardless of how reliable it is. The Stratus CA Framework addresses these needs through expert analysis, design for availability, provisioning, deployment, and on-going operations management and control."