RegDocs365 Description
A scalable, real-time, collaborative, out-of-the box solution for CROs, Life Science Consultants and Industry Stakeholders. Built in an Audit Ready Compliant Cloud environment (ARCC). All 21 CFR Part 11 requirements are met. GxP audit ready. Pre-configured Departmental. Communications with internal and external stakeholder. Secure data integration between remote teams. Collaboration in review and approval. Turn access on/off according to need (EX: auditors), reducing audit prep time from days to hours. Preconfigured to eTMF Reference models & EDM. Intelligent content management tools can improve workflows. Improve document management with real-time collaboration, automatic indexing and co-authoring. Pre-configured, validated system that manages documents and data electronically in accordance with eCTD mandates.
RegDocs365 Alternatives
isoTracker Quality Management is a popular cloud-based quality management software (QMS) system. It is used on a worldwide basis by businesses to manage their ISO 9001, ISO 13485, ISO 22000, ISO 17025, ISO 14001 systems...plus many others.
It is a modular product which can be configured to meet an organization's specific requirements and is competatively priced with superg customer support. Any module combination of Document Control, Complaints, CAPA, Audits, Training, Non-Conformance and Risk can be subscribed to.
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Interfacing’s Integrated Management System (IMS ) is an AI-supported platform that brings BPM, QMS, Document Control, and GRC together in one environment. Teams use IMS to design and manage processes, govern documentation, oversee risks, and demonstrate compliance with complete visibility and reliable audit evidence.
Built for sectors that depend on strict oversight, such as aerospace, life sciences, public sector, and financial services, IMS offers real-time monitoring, automated workflows, and AI-driven analytics that strengthen quality and lower operational exposure. The system is ISO 27001 certified and validated for 21 CFR Part 11, ensuring secure and compliant use in regulated operations. IMS also provides low-code automation, process mining, audit tools, training management, CAPA workflows, and dashboards that help organizations improve performance and maintain regulatory control. AI enhances governance, improves precision, and supports continuous compliance.
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QT9 QMS
Unify quality processes with QT9's all-in-one cloud-based QMS Software Suite. QT9 QMS is a user-friendly quality management software that includes 25+ modules with unlimited scalability. Automate ISO & FDA Compliance with email alerts, To Do lists and FDA 21 CFR Part 11 Compliant Electronic Approvals.
QT9 QMS enables Life Sciences, Biotechnology Companies, Medical Device Manufacturers and Pharmaceutical Companies to digitally transform operations.
Get real-time status updates and visualize quality metrics up-to-the-minute. QT9 QMS comes with built-in document control, revision-level controls, corrective actions (CAPAs), Nonconforming products and more. Advance product releases with Deviation Management, Engineering Change Orders, FMEA, Inspection Management Modules Included.
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Qualtrax
Qualtrax is a quality and compliance software program that can manage and control documentation, automate key business processes, streamline training management, manage external and internal audits, and ensure that critical industry regulations are met in real time. Qualtrax is a valuable resource in highly-regulated industries where compliance with standards such as ISO 17025 and 17020, 13485 and 9001, TNI and GFSI, FDA and FQS are required.
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Pricing
Pricing Information:
Per user, Per month
Integrations
Company Details
Company:
Court Square Group
Year Founded:
1995
Headquarters:
United States
Website:
www.regdocs365.com
Media
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Product Details
Platforms
Web-Based
Types of Training
Training Docs
Live Training (Online)
In Person
Customer Support
Business Hours
Live Rep (24/7)
RegDocs365 Features and Options
Clinical Trial Management Software
21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning
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