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Biotechnology Quality Management Solution
Leading Quality and Compliance Solutions for the Biotechnology Industry
Dot Compliance delivers an end-to-end eQMS that helps biotech organizations maintain quality and compliance across operations. It integrates core quality processes, including document control, CAPA management, supplier quality, and training, into one system. This structure ensures that every document, task, and approval is recorded, traceable, and compliant with global regulations.
Automation within Dot Compliance replaces repetitive manual tasks, allowing teams to manage more work with fewer errors. Real-time dashboards provide visibility into performance metrics, quality events, and audit readiness. The system also includes built-in AI capabilities that help identify trends and recurring issues so that teams can address them early. These insights support continuous improvement and ensure that quality remains consistent across departments and product lines.
Dot Compliance is designed to grow with biotechnology organizations. Companies can start with foundational modules and expand as operations evolve, reducing implementation time and validation effort. This modular structure supports flexibility without compromising compliance or control, giving biotech teams the ability to scale quickly and maintain operational efficiency.
Supply Chain Traceability
Maintaining supply chain traceability is critical in biotechnology, where material consistency and product safety directly impact patient outcomes. Dot Compliance helps biotech companies manage supplier quality by automating qualification, tracking performance, and documenting audits and corrective actions. All supplier data and related records are connected within the eQMS, creating a single source of truth for materials, vendors, and quality events.
When deviations occur, the system enables teams to record the issue, investigate the cause, and complete CAPAs with full traceability. This visibility ensures that every material and supplier meets defined standards. By centralizing supplier oversight, Dot Compliance supports compliance with global regulations and simplifies the preparation for inspections or audits. The result is a transparent supply chain that supports both operational reliability and product integrity.
Regulatory Compliance
Biotechnology companies must demonstrate compliance with multiple global regulations, including FDA, EMA, and GMP standards. Dot Compliance supports this requirement with built-in tools that maintain data integrity, security, and traceability. Every action is captured in a complete audit trail, and all documentation is stored in a validated, controlled environment. The system enforces electronic signatures, access controls, and change tracking in line with 21 CFR Part 11 and Annex 11.
Through structured workflows, organizations can standardize documentation, approvals, and reviews. This ensures that all processes follow regulatory expectations without manual oversight. The system’s dashboards and reports provide clear visibility into compliance status, helping quality leaders identify gaps and prepare for inspections. Dot Compliance reduces the administrative burden of compliance and helps biotech teams maintain consistent, verifiable control across all activities.
Product Safety and Efficacy
Product safety and efficacy are central to every biotechnology operation. Dot Compliance provides tools to record, investigate, and resolve quality events, deviations, and CAPAs in a timely and structured way. Automated workflows guide each step, ensuring accountability and complete documentation. The platform connects related data such as training records, SOPs, and change requests, giving teams a complete view of the event’s root cause and resolution.
With real-time dashboards and analytics, quality teams can identify patterns, monitor performance, and take preventive actions before issues escalate. These insights help organizations maintain consistent production quality and ensure every product batch meets required specifications. By providing full traceability and reliable data, Dot Compliance supports regulatory submissions, inspections, and internal audits with confidence.
Dot Compliance enables biotechnology companies to strengthen their quality culture and maintain control as they scale. The system combines automation, traceability, and AI insights to support safe, compliant, and efficient innovation. With one connected platform, biotech organizations can manage all aspects of quality, from development through manufacturing, with accuracy, speed, and confidence.
How Dot Compliance Helps
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.
