Audience
Pharmaceutical, biotech, life science, medical device vendors, and more
About RegDocs365
Out-of-the-box, scalable, real-time collaborative solution for CRO’s, Life Science Consultants, Regulatory Groups and Industry Stakeholders. Built in an Audit Ready Compliant Cloud (ARCC) environment. Meets all 21 CFR Part 11 requirements. GxP audit ready. Pre-configured Departmental. Internal/External stakeholder communications. Secure data integration across remote teams. Collaborative review and approval workflow. Turn access on/off as needed (EX: auditors, reducing audit prep time to hours vs days). Preconfigured to EDM & eTMF Reference Models. Improve workflows through intelligent content management tools. Unify and improve the document management lifecycle with real-time collaboration, automatic indexing, and co-authoring capabilities. Pre-configured validated system that easily manages documents and data electronically that complies with eCTD mandates.
Other Popular Alternatives & Related Software
MediaLab Document Control
MediaLab’s Document Control is a powerful way to manage your laboratory’s policies, procedures, and documentation. Our twenty years of expertise in clinical laboratories have created a document control solution that guides you to full compliance with all laboratory standards, regulations, and best practices. Document Control provides an automated, centralized platform for all of your document approvals, workflows, edits, sign-offs, audits, and more—with flexibility and customization features to match your laboratory’s unique needs.
MediaLab's Document Control supports:
• Digital records and version control of all documents,
• Standardization across all documents from all sites,
• Electronic signatures that meet 21 CFR Part 11 standards,
• Customized approval workflows and processes,
• Robust searching to easily locate specific documents, and more!
Learn more
TenForce
Track, analyze and report on your EHSQ processes from a single platform.
Automate workflows, centralize data and simplifiy collaboration across departments.
TenForce offers various integrated modules to help streamline processes such as Audits, Incident Management, CAPA, Permit to Work, Management of Change, and Shift Management.
It offers mobile capabilities, which allow field workers and inspectors to access the software on mobile devices.
Its built-in data analytics and reporting functionality enables managers to gain insights into the processes and risks of their industrial plants or public infrastructure assets.
This visibility helps them address environmental, health, safety, quality, and compliance issues.
TenForce helps manufacturers optimize their established processes while minimizing incidents.
Learn more
QT9 QMS
Struggling with complex compliance requirements or disconnected quality systems? QT9 QMS eliminates these challenges with one integrated, fully validated platform that scales with your business.
Designed for life sciences, aerospace, and manufacturing, QT9 offers cloud or secure on-premise deployment to meet your needs. Stay audit-ready automatically with built-in FDA, ISO, and EU MDR compliance while reducing manual work by up to 70%.
With 28+ modules included—like document control, CAPA, training, and supplier management—QT9 deploys fast without costly customization. Backed by ISO 27001 certification, unlimited support, and 20+ years of proven success, QT9 helps 1,100+ organizations accelerate compliance, improve visibility, and simplify quality management.
Start your free trial or book a personalized demo today.
Learn more
Dot Compliance QMS
Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements.
Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE!
Processes included:
▶ Document Management
▶ Training Management
▶ Quality Event Management
▶ CAPA Management
▶ Change Management
▶ Complaint Management
▶ Audit Management
▶ Supplier Quality Management
▶ Risk Management
▶ Design Control
▶ Deviations/Non-conformances
✔ Seamless Install
✔ Cost Effective
✔ One-Stop-Shop
Learn more
Pricing
Pricing Details:
Per user, Per month
Integrations
Company Information
Court Square Group
Founded: 1995
United States
www.regdocs365.com
Videos and Screen Captures
Other Useful Business Software
Our Free Plans just got better! | Auth0
You asked, we delivered! Auth0 is excited to expand our Free and Paid plans to include more options so you can focus on building, deploying, and scaling applications without having to worry about your security. Auth0 now, thank yourself later.
Product Details
Platforms Supported
Cloud
Training
Documentation
Live Online
In Person
Support
Phone Support
24/7 Live Support
RegDocs365 Frequently Asked Questions
RegDocs365 Product Features
Clinical Trial Management
21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
HIPAA Compliant
Enrollment Management
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning
