“Dot Compliance has helped us be more efficient in our processes, while also maintaining a high level of compliance in a highly regulated industry.”
Electronic Batch Record (EBR)
Gain full visibility to easily manage your manufacturing processes
Join the Industry’s Leading Life Sciences Professionals Who Trust Dot Compliance
Streamline batch record management
Life sciences organizations are reaping the benefits of electronic batch records to improve efficiency, ensure accuracy, and streamline operations.
Integrate with Other Systems
Electronic batch records seamlessly connect with systems like eQMS, LIMS, and ERP to create a unified digital environment. This integration eliminates data silos, streamlines workflows, and improves coordination across production, quality, and supply chain operations. By connecting critical systems, teams gain real-time visibility and control over every stage of manufacturing.
Gain Effortless Scalability
Electronic systems adapt easily to growing production volumes and evolving process complexity. Dot Compliance supports scalability by enabling organizations to add new products, sites, or workflows without disrupting existing operations. This flexibility helps companies stay agile and maintain efficiency as they expand.
Reduce Risk of Errors
Automated data entry and recordkeeping significantly reduce human error and ensure accuracy across all production records. Built-in validation rules verify inputs at every step, maintaining data integrity and regulatory compliance. With consistent, error-free documentation, teams can trust their records and accelerate batch release.
Why Dot Compliance Electonic Batch Record Solution
Dot Compliance’s electronic batch record (EBR) solution enables organizations to monitor, manage, track, document, and report on quality processes to ensure the production of manufactured products that are compliant with global standards and regulations. This means organizations can eliminate paper trails and human error and harmonize manufacturing processes.
Features and Benefits
Gain visibility by integrating the eQMS with MES
Seamlessly integrate between eQMS and MES to deliver full visibility into EBR to easily manage manufacturing processes.
Meet compliance with regulatory agencies and standards
Ensure compliance with regulatory agencies like the FDA and the EMA, as well as cGMP standards.
Better document management
Allows users to organize, manage, and track documents, images, and other digital content necessary for conducting clinical trials.
Automate the process and alleviate the manual burden
Reduce effort associated with paper-based processes by linking quality documents in the manufacturing process, including work instructions, SOPs, electronic forms, batch records, and test results.
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