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Biotechnology Quality Management Solution

Innovate faster with eQMS solutions for the biotech industry

Leading Quality and Compliance Solutions for the Biotechnology Industry

Supply Chain Traceability

Supply chain traceability is vital in biotechnology, where material quality impacts patient safety. Dot Compliance automates supplier qualification, performance tracking, and corrective actions, connecting all records in one eQMS for full visibility. When deviations occur, teams can investigate, document, and close CAPAs with complete traceability. This centralized oversight ensures suppliers meet standards, supports global compliance, and strengthens product integrity.

Regulatory Compliance

Biotech companies must comply with global regulations such as FDA, EMA, and GMP standards. Dot Compliance simplifies this with built-in tools that ensure data integrity, security, and traceability. Every action is recorded in an audit trail, and all documentation is managed in a validated, controlled environment with electronic signatures and access controls per 21 CFR Part 11 and Annex 11. Structured workflows standardize documentation and approvals, while dashboards give teams real-time visibility into compliance status and inspection readiness.

Product Safety and Efficacy

Product safety and efficacy are at the core of biotechnology operations. Dot Compliance helps teams record, investigate, and resolve quality events, deviations, and CAPAs through automated workflows that ensure accountability and documentation. The platform links related data—like training, SOPs, and change requests—for full visibility into root causes and resolutions. Real-time dashboards highlight trends and risks so teams can act before issues escalate. With automation, traceability, and AI insights in one system, biotech companies can maintain compliance, improve quality, and scale with confidence.

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.

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.