Clearing the skies in GxP compliance

In this era of digital transformation, cloud computing is proving to be a vital pillar.

An enabler of artificial intelligence and virtual and augmented reality technologies, it helps to ease the responsibilities of organisations with cost-effective pay-as-you-go solutions, computing scalability, advanced analytics and automation. Together, these give cloud infrastructure, which is based on a shared responsibility model, an edge over on-premises infrastructure. 

Little wonder then that pharmaceutical, medical devices and biotech companies are increasingly exploring digital solutions to improve and optimise various processes, such as collaborative research and real-time data analysis across the pharma value chain, and to accelerate profitability. GxP, an abbreviation for "good practice" regulations and guidelines in the life sciences industry, apply.

Read on for a phased approach to implementing GxP compliance in cloud infrastructure and colocation facilities. 

1. Regulatory changes

With organisations looking to implement next-generation technologies, including cloud, regulatory bodies are rolling out guidance to ensure compliance and data integrity. The US Food and Drug Administration (FDA), for instance, has published a new draft guidance that addresses existing barriers to technology adoption and encourages the use of automation tools and underlying IT solutions. 

2. Phased approach for cloud adoption

Onboarding cloud infrastructure requires a phased approach — from concept to operational stage — to ensure that all risks are considered, mitigation controls implemented and required evidence documented for a smooth and compliant movement to the cloud landscape. Download our full report for more details on each phase.

3. Compliance risks in cloud adoption

Life sciences organisations operating in GxP areas like research and development are still hesitant in embracing cloud technology. However, implementation of adequate controls and compliance checkpoints can mitigate data integrity and security risks and help them stay compliant.

4. Way forward

As cloud-based IT Infrastructure is gradually adopted across the life sciences value chain, it is essential that opportunities and threats associated with cloud implementation are mapped out and well-defined to open new avenues for implementing strategic and innovative solutions.


Get in touch

Connect with us

Related content