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Pharmaceutical Quality Management Solution

Enable faster, safer innovation with the leading AI-powered eQMS for pharma

Leading quality and compliance solutions for the pharmaceutical industry

Optimize Data Management and Integrity

Pharmaceutical companies handle large volumes of data across research, manufacturing, and quality operations. Dot Compliance centralizes this data in a validated, cloud-based system to ensure accuracy and compliance. Automated workflows reduce errors by guiding users through each process, while role-based permissions and audit trails maintain control and traceability. Real-time dashboards provide visibility into key metrics and trends, helping teams make faster, data-driven decisions. With a single source of truth, organizations can operate more efficiently and maintain continuous regulatory compliance.

End-to-End Quality Management

Dot Compliance connects all quality processes—from document control and training to CAPA, change management, and audits—within one unified platform. Its integrated design standardizes procedures, enforces accountability, and maintains control across manufacturing and supply chain operations. Automation reduces manual effort and shortens approval cycles, allowing teams to focus on key quality activities. With centralized visibility, pharmaceutical companies can manage issues in real time, meet GxP, ISO, and ICH requirements, and continuously improve overall quality performance.

Effective Documentation and Record-Keeping

Accurate, controlled documentation is critical for compliance and traceability in pharmaceutical manufacturing. Dot Compliance’s document management module ensures all records—from SOPs to batch records—are securely stored, reviewed, and approved in a compliant environment. Version control, access management, and electronic signatures meet FDA 21 CFR Part 11 and EU GMP Annex 11 requirements. Centralized document control keeps everyone working from the latest approved versions, reduces audit prep time, and improves collaboration. By connecting all quality processes in one system, pharmaceutical companies gain stronger data integrity, continuous compliance, and greater operational efficiency.

How Dot Compliance Helps

AI-Powered Quality Solution

Dottie AI by Dot Compliance scans vast amounts of text across your organization to identify correlations and trends and to provide you with timely AI insights. This enables pharmaceutical organizations to make data-driven decisions that help accelerate the drug development cycle while meeting regulatory compliance.

A Digital Approach to Quality Management

Dot Compliance’s pre-configured, ready-to-deploy eQMS software streamlines complex processes by automating tasks that are prone to human error and enabling a proactive approach to quality management. This ensures quality in every step of the drug development process, so you can get your products to patients quickly and safely.

Better Document Management

Dot Compliance’s document management system enables pharmaceutical organizations to effectively manage the entire life cycle of all documents. This solution controls access to each document to prevent unintended alterations and to protect data integrity. This means organizations can be confident that their data is of the utmost quality and only accessible to those who need it.

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.