As a life sciences manufacturer, there’s mounting pressure to integrate artificial intelligence (AI) across the product lifecycle and capitalize on the opportunities this technology presents to the industry. Organizations face the complex challenge of balancing innovation with regulatory compliance.
Safe and effective adoption of AI can require rigorous evaluation. You must be confident that AI capabilities that are (1) built in-house by your company or (2) are built by a vendor you are partnering with uphold the highest standards of compliance, product safety, data integrity, and patient protection.
Adding to that is the complexity of regulations and guidelines. Guidance and protocols continue to evolve globally, causing uncertainty among life sciences professionals around standards and compliant AI adoption.
In this evolving regulatory environment, uncertainty can cause hesitation and a “wait and see” approach for AI adoption. However, with the right trusted partner, you can confidently accelerate your adoption of AI, and benefit sooner from the time savings, improved efficiencies, and other advantages that come with strategic usage of AI in your processes. Life sciences manufacturers’ operational needs and compliance requirements are at the core of MasterControl’s approach to AI development. As guidance from global regulatory bodies evolves, we also continue to evolve to ensure we build secure AI tools that help you save time and work more efficiently, without sacrificing compliance.
By focusing on the five key areas we’ve identified below you can ensure the AI you are evaluating to integrate into your quality and manufacturing processes meets regulatory requirements. At MasterControl, we understand the effort and time/resource investment required to thoroughly evaluate AI for regulatory compliance. That’s why we’ve done the work for you with the AI tools we build and release. MasterControl ensures we are addressing these five areas with our AI development so that life sciences manufacturers can easily and confidently adopt our compliant AI into their processes.
SeerPharma's strategic partner MasterControl can help you with a publication addressing 5 critical requirements for AI compliance in life sciences:
- Data Integrity and Electronic Records
- Assessing Fit for Use
- Transparency and Explainability
- Risk Management
- Data Privacy and Security
*About MasterControl
MasterControl Solutions Inc. is a leading provider of cloud-based quality, manufacturing, and asset management software for life sciences and other regulated industries. For three decades, our mission has been the same as that of our customers – to bring life-changing products to more people sooner. MasterControl helps organizations digitize, automate, and connect quality, manufacturing, and asset management processes and has a proven track record of improving product quality, reducing costs, and accelerating time to market. Over 1,100 companies worldwide use MasterControl to streamline operations, maintain compliance, manage critical assets and equipment, easily analyze and interpret large amounts of data, and visualize business insights in real time.
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