“Dot Compliance has helped us be more efficient in our processes, while also maintaining a high level of compliance in a highly regulated industry.”
Pharmaceutical Quality Management Solution
Enable faster, safer innovation with the leading AI-powered eQMS for pharma
Join the Industry’s Leading Life Sciences Professionals Who Trust Dot Compliance
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 ready-to-deploy QMS software that delivers speed and smarts
Used by life sciences organizations around the world, Dot Compliance empowers teams to manage quality with confidence, maintain continuous compliance, and keep every process inspection ready.
FAQs
Do I need Salesforce to use Dot Compliance?
No. Dot Compliance runs on the Salesforce platform, but you don’t need a separate Salesforce license. Everything you need is included.
Is Dot Compliance validated?
Yes. All of our solutions come with full validation packages and meet global regulatory standards, including 21 CFR Part 11 and EU Annex 11.
Can I start small and scale later?
Absolutely. Our modular platform lets you start with what you need today and add more over time as your organization grows.
What support is available after go-live?
Absolutely. Our modular platform lets you start with what you need today and add more over time as your organization grows.
How does Dot Compliance support life sciences companies?
Dot Compliance provides a comprehensive eQMS tailored to life sciences. It covers everything from document control and CAPA management to training and regulatory compliance and much more.
How does Dot Compliance ensure fast implementation?
Dot Compliance offers pre-configured, ready-to-deploy solutions that allow for rapid deployment, enabling life sciences companies to get up and running quickly without extensive customization.
Can Dot Compliance integrate with existing systems?
Yes, Dot Compliance integrates easily with ERP systems and other critical tools through its native Salesforce platform, providing seamless connectivity.
Global compliance, baked in
Quality & Compliance Standards
- ISO/IEC 42001 (AI Management Systems)
- ISO 9001 (Quality Management Systems)
- ISO/IEC 27001 (Information Security Management Systems)
- GAMP 5 (Good Automated Manufacturing Practice for GxP Systems)
- ISO/IEC 27017 (Cloud Security)
Medical Device
- 21 CFR Part 820
- ISO 13485
- ISO 14971
Pharma & Biotech
- 21 CFR Part 210
- 21 CFR Part 211
- cGMP, cGDP, GCP