With the increasing acceptance of virtualization, cloud computing and requirements for optimizing IT, Life Science companies are looking more closely at a managed services model for Computer System Validation (CSV) and compliance. The Life Sciences industry has the same drivers as other industries to continually assess the effectiveness of processes and to lower associated costs, however, historically in the compliance and quality arena, Life Science companies have been reticent in adopting a managed services model. It’s always a question of how to justify this model to the regulatory agencies when they come calling. Quality or regulatory groups, tasked with assessing the impact and risks associated with making changes to how these activities are performed, have little interest in changing what has worked for them in the past. The expected benefits just weren’t sufficient to escape the continual regulatory challenges.  However, the increasing adoption of cloud environments is bringing discussions around compliance methodologies back on the table providing opportunities to re-think how compliance is managed.

Global Labor Arbitrage

Over the last decade or so, Life Science companies have embraced moving traditional IT services to lower cost IT centers throughout the world. Regulatory concerns have limited movement of compliance and quality related services. The companies that have successfully moved compliance and quality services to these areas have certainly realized significant lowering of labor costs on a full time equivalent (FTE) basis. However, this has been a mixed bag sometimes increasing rework, communications issues, management, and overall project delays.

Compliance Risk Management

Companies have also adopted risk based approaches to compliance to better focus efforts in certain areas. These efforts have helped organizations get past some of the traditional challenges of validating all systems in the same way, with the same set of deliverables and processes, and high overhead. Companies that haven’t adopted a risk based approach require much higher levels of effort to complete projects and manage programs compliantly. What has not worked well in the move to risk based processes is the inability to translate or implement procedures in an effective way that truly reduces risk. The business needs to be engaged and involved in the risk assessment process and the availability of resources that are able to objectively assess risks in a consistent manner and formulate adequate and appropriate mitigation steps remains a challenge.

What does the future hold?

Ultimately, Life Sciences companies should be looking towards proactively managing risk and compliance while looking for efficiencies; managed service programs can support that. Managed services models where there is a heavy focus on quality and risk management while introducing more “factory-like” processes and service level agreements will offer life science companies an opportunity to get efficiency and cost gains while still minimizing regulatory exposure.

Learn how Life Science companies are adapting to some of the unique challenges and benefits of contracting these services in subsequent posts.

USDM is transforming traditional managed services approach through our strategic Compliance as a Service offering

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About the Author

Mike Canale 85x105Michael Canale is the Vice President of Compliance Wellness at USDM Life Sciences. Michael has more than 20 years of experience providing strategic information management and regulatory compliance consulting services within the Life Sciences industry, including the implementation of quality and compliance programs, policies, and guidance in the areas of Computer System Validation, Auditing, Risk Management, and 21 CFR Part 11 compliance.

About USDM Life Sciences

USDM Life Sciences is a global life science and healthcare services company, providing strategy and compliant technology solutions to regulated industries. If you work in Life Sciences or Healthcare, partnering with USDM Life Sciences makes it easy to accelerate innovation and maximize productivity. USDM Life Sciences only focuses on regulated industries and has built trusted partnerships with the most innovative technology companies in the world, and boast a staff of industry leading experts in the areas of technology and compliance.

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