Biotechnology Quality Management Solution

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Join the Industry’s Leading Life Sciences Professionals Who Trust Dot Compliance

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.
“Dot Compliance has helped us be more efficient in our processes, while also maintaining a high level of compliance in a highly regulated industry.”
Adam Miller
Former Head of Quality

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.

Document Management
Document Management
Change Management
Change Management
Quality Event Management
Quality Event Management
Audit Management
Audit Management
Training Management
Training Management
CAPA Management
CAPA Management
Complaint Management
Complaint Management
Risk Management
Risk Management
Supplier Quality Management
Supplier Quality Management
Equipment Management
Equipment Management
Electronic Batch Management
Electronic Batch Management

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

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

Medical Device

  • 21 CFR Part 820
  • ISO 13485
  • ISO 14971
Pharma & Biotech

Pharma & Biotech

  • 21 CFR Part 210
  • 
21 CFR Part 211
  • 
cGMP, cGDP, GCP