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Pharmaceutical Quality Management Solution
Leading quality and compliance solutions for the pharmaceutical industry
Optimize Data Management and Integrity
Pharmaceutical companies generate and manage vast amounts of data across research, manufacturing, and quality functions. Dot Compliance centralizes this information within a validated, cloud-based system, ensuring accuracy, accessibility, and compliance. Automated workflows minimize human error by guiding users through each required step of a process. Role-based permissions and audit trails maintain strict control over who can access, edit, or approve records.
This approach supports compliance with regulatory bodies such as the FDA and EMA by maintaining complete data integrity throughout the product lifecycle. Real-time dashboards allow teams to track performance indicators, review trends, and make informed decisions faster. By connecting data across departments, Dot Compliance helps organizations establish a single source of truth that supports consistent, compliant operations.
End-to-End Quality Management
Dot Compliance delivers full lifecycle quality management, connecting every process from document control and training to CAPA, change management, and audits. The platform’s unified design helps teams standardize procedures, enforce accountability, and maintain control throughout manufacturing and supply chain operations. Automation reduces administrative tasks and shortens approval cycles, giving teams more time to focus on critical quality activities.
With centralized data and visibility across all quality events, pharmaceutical companies can manage deviations, corrective actions, and preventive measures in real time. This end-to-end control helps ensure faster product release timelines while maintaining compliance with GxP, ISO, and ICH standards. It also supports continuous improvement by making it easier to analyze outcomes, assess performance, and identify opportunities to strengthen quality practices.
Effective Documentation and Record-Keeping
Accurate, controlled documentation is essential for regulatory compliance and traceability in pharmaceutical manufacturing. Dot Compliance includes a document management module that ensures every record, from SOPs to batch records, is stored, reviewed, and approved within a compliant environment. Version control, access management, and electronic signatures meet the requirements of FDA 21 CFR Part 11 and EU GMP Annex 11.
By centralizing document management, all stakeholders work from the most current, approved versions, reducing the risk of using outdated or incorrect information. The system also simplifies preparation for audits and inspections by providing quick access to complete, validated records. This transparency strengthens collaboration across departments and ensures that all quality documentation remains accurate, consistent, and audit-ready.
Dot Compliance helps pharmaceutical companies move from manual, reactive quality management to an automated, connected model that supports continuous compliance and faster innovation. With one system managing all quality processes, pharmaceutical organizations can achieve better control, stronger data integrity, and greater operational efficiency across the entire product lifecycle.
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.
