Quality management
Challenges
Quality is an increasing concern for the life sciences sector. Companies and research institutes are facing stricter European and global regulations which limit the advances of R&D whilst increasing costs. The main challenges are:
- Implementation of legislative requirements (certifications and norms; ISO 9000, EFQM)
- Managing complicated and complex processes in R&D (clinical trials, production sites, research process and security requirements)
- Aligning projects and priorities
- Performance evaluation
These changes create an increasingly competitive environment that requires Luxembourg’s life sciences industry to have a well-defined two- to three-year strategic plan and underlying roadmap in order to be able to adapt to the changes enforced by the regulators.
Quality is becoming a key differentiator and full compliance with the ISO 9000 and EFQM standards is increasingly important, as is the need for a well-considered and comprehensive performance management and monitoring strategy, and the need for integrating qualitative and quantitative indicators.
Deloitte service offering
We assist life sciences with a service offering that will support them in improving the quality of their services. This service offering spans from (cross-border) benchmarking, optimisation of functional and operational processes and procedures, governance, automation, performance management and dashboard definition to employee and customer surveys, ISO and EFQM audits and EFQM certifications:
- Benchmarking analysis on different aspects (client and personnel satisfaction, process efficiency and effectiveness)
- Development of strategies, implementation of roadmaps and assistance in implementation
- Design of employee and patient surveys, results analysis and development of recommendations/action plans
- Optimisation of resources, processes and costs, including analytical accounting, shared service centres, selective outsourcing, dashboards/business intelligence and activity-based costing
- Design and implementation of quality programmes covering the different dimensions of quality: effectiveness, efficiency, technical competence appropriateness, acceptability and safety
- Guidance with ensuring that the organisation meets the new legislative requirements (e.g. cost analysis) on elements such as IT systems, governance and skill sets
Material on this website is © 2013 Deloitte Global Services Limited, or a member firm of Deloitte Touche Tohmatsu Limited, or one of their affiliates. See Legal for copyright and other legal information.
Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee, and its network of member firms, each of which is a legally separate and independent entity. Please see www.deloitte.com/about for a detailed description of the legal structure of Deloitte Touche Tohmatsu Limited and its member firms.