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Biotechnology Quality Management Solution

Innovate faster with eQMS solutions for the biotech industry
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Leading quality and compliance solutions for the biotechnology industry

Supply chain traceability

Maintaining a transparent and traceable supply chain is essential for product integrity in the biotech industry. Effective traceability reduces supply chain disruptions, ensuring smoother operations and compliance.

Regulatory compliance

Biotech companies must adhere to strict regulatory requirements, including FDA, ISO, and GMP standards. Meeting these requirements safeguards patient safety, prevents fines and reputational damage, and supports smooth operations across clinical trials, product approvals, and post-market surveillance.

Product safety and efficacy

Biotech companies must innovate rapidly while maintaining product safety and efficacy. This demands rigorous testing, reliable quality control, and ongoing monitoring to ensure each product batch meets the highest standards.

 

How Dot Compliance Helps

Supply Chain Management
Due to supply chain challenges, biotech companies must prioritize transparency and visibility across the supply chain. Dot Compliance’s AI-powered eQMS enables the biotech industry to trace products across the supply chain, proactively identify disruptions and identify vulnerabilities.
Integrated Quality Management and Compliance
Dot Compliance helps biotech companies navigate complexities through integrated quality management solutions that meet compliance and automate critical processes. Our eQMS streamlines biotech quality and compliance processes and is customized based on your unique requirements. The solution is fully validated and pre-configured to meet compliance.
AI-Powered Insights
The power of AI is unmatchable. With Dot Compliance’s AI-powered eQMS solution, your organization can analyze vast amounts of data to detect patterns and trends that may result in quality issues or deviations. With this insight, you can proactively address these events to prevent occurrence and ensure the safety and efficacy of your product.

The eQMS that keeps you one step ahead 

Dot Compliance is the industry’s first AI-powered eQMS, built to get you up and running fast – and to give you the insights to drive quality efficiently.

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Smart solutions for life sciences companies at every stage 

Meet the eQMS that evolves with you, from setting a foundation with core processes to the industry’s most sophisticated AI quality and compliance intelligence.

eQMS Xpress

Establish your eQMS foundation with a comprehensive set of ready-to-use core quality processes.

Compliance Xpand

Grow with additional modules to support cross-functional processes as your business evolves.

Enterprise Xact

Customize and configure your eQMS to meet your unique quality and compliance requirements.

AI Xpert

Analyze enterprise data across any source to proactively flag quality and compliance risks.