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Enable cross-functional collaboration and accelerate your product lifecycle with a cloud-based platform for innovation
Design Process and Quality System Development Tools in Product Lifecycle
Get full visibility over your product design processes and make collaboration easy to get your products to market faster, compliantly
Design Quality: Connecting Design to Documentation
Transform customer complaints to valuable sources of insights for continuous improvement through smart automations and integrated regulatory reporting
Challenges with Triage and Investigation in Complaints Management Process
Say goodbye to paper! Modernize your processes with connected document, training, and change management
Manufacturing Challenges and Industry Trends Towards Digital Transformation
Transform quality into an enabler: boost efficiency, increase satisfaction, and trim costs with a fully connected, AI-powered quality management solution
Frost Radar for Quality Management Systems Names ComplianceQuest Leader
Enable risk-based thinking throughout your quality processes with a fully integrated risk management solution
Automation of the Risk Management Lifecycle with AI and Analytics
Increase supplier performance, reduce costs, and streamline your supply chain with integrated supplier quality and collaboration tools
The Ultimate Guide to Next-Generation Supplier Management [e-Book]
Identify and minimize safety events. Prevent accidents, safeguard workers, and ensure their well-being and health
Safety Essentials: Key ‘Must-have’ Components for Safety Management at Any Enterprise
Proactively and accurately monitor and measure your company’s impact on the environment to improve performance and reach your environmental and sustainability targets
Environmental & Sustainability Management
Electronic and Automated Approach to Audit Management
Managing the Tools of the Trade
Manage Operational Risk Tracking, Evaluation, Mitigation and monitoring
Leveraging CAPA for Continuous Improvement
Ensure your laboratory is compliant with systematic and efficient laboratory investigations
Incident Reporting and Management
Organization, Collaboration and Governance for Efficient Changes
Conduct smart management review meetings with a tower of data to improve your quality and safety systems
Gain 360 degree vision into enterprise wide Safety risks
Enhance Safety and Compliance with Smarter Chemical Management
Ensuring Quality across Departments & Locations
Partner With Suppliers And Vendors To Improve Quality And Safety
Create Loyalty by Addressing Customer Complaints Smartly
Bring Consistency to Permit Practices
Make it easy for your people to manage, track and analyze environmental and sustainability metrics
Bring higher quality products to market quicker with design controls, projects & DHF
Streamline Permit Management and Ensure Compliance
When Learning Propels Organizational Growth
Improve efficiency, productivity, and compliance with a solution designed for today's diverse workforce learning styles
Strategically manage the complete lifecycle of your product
Efficient Waste Management for Compliance & Sustainability
Relevant Information within reach - Always.
Assuring Quality Products and Services
ComplianceQuest covers the whole spectrum of customers, industries and regions across the world. Whether it is a small, medium or enterprise sized manufacturer, companies choose ComplianceQuest for its end-to-end Product Lifecycle, Quality, Safety and Supplier Management Solutions.
Leveraging AI to Create a Safer Workplace Environment
Why an EHS Solution Built on Salesforce Works Better Than One Built on AWS or Azure
Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
ComplianceQuest Medical Devices QMS Success Stories eBook
Complaint Handling Process for MedTech and Life Science Companies
Audit Management
Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
Unlocking the Value of Complaints
Why You Need to Digitally Transform Your QMS
The Ultimate Guide to ISO/IEC 17025:2017 Compliance
Safety Technology Trends to Watch in 2023 (Infographic)
Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
American Society of Quality Lean Six Sigma Conference
23 Feb, 2025
Phoenix, AZ
Transform to a fully connected business with a next-generation AI-powered Product Lifecycle, Quality, Safety, and Supplier management platform, built on Salesforce.
Our connected suite of solutions helps businesses of all sizes increase product, quality, safety, and supplier as they bring their products from concept to customer success.
Where Your Career Takes Flight: Join our dynamic team and be part of an innovative, collaborative and rewarding workplace culture.
Impact Through Action: How the ComplianceQuest team supports social causes and community engagement
The Pulse of ComplienceQuest: Our newsroom shares stories of innovation, progress, and change
Stronger Together: How our partnerships drive success and innovation
Effortlessly handle all your regulatory documents within a single, centralized database.
Streamline the authoring, reviewing, approval, and tracking of regulatory documentation.
A Regulatory Document Management System (rDMS) is a specialized software that is used by organizations in various industries, including pharmaceuticals, healthcare, finance to streamline and centralize the creation, storage, retrieval, and management of documents and data. With rDMS, organizations can showcase their commitment to the ever-evolving regulatory requirements set forth by government agencies and other industry bodies.
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The importance of a Document Management cannot be overstated, particularly in industries subject to stringent regulatory oversight. rDMS plays a pivotal role in ensuring compliance, efficiency, and the overall success of organizations in these sectors.
rDMS enhances compliance by centralizing and standardizing the management of regulatory documents. This reduces the non-compliance risk. With rDMS, businesses across industries can consistently meet the latest regulatory requirements while also keeping the documents ready for inspections and audits.
Efficiency is also a key benefit of rDMS. It helps organizations streamline their document creation, review, and approval processes. With this advantage, organizations can reduce the time and effort required to remain compliant with regulations. As a result, organizations have better cost savings benefit and allows them to allocate resources more effectively.
rDMS also improves data security by implementing access controls and audit trails, protecting sensitive information from unauthorized access or alterations. This enhances the integrity and confidentiality of critical regulatory documents.
A Regulatory Document Management System (rDMS) offers a comprehensive set of key features tailored to the needs of organizations operating in heavily regulated industries. These features are crucial for ensuring regulatory compliance, document control, and streamlined operations:
Document Centralization
rDMS consolidates all regulatory documents, such as policies, procedures, guidelines, submissions, and compliance records, into a centralized, organized repository. This simplifies document access and management.
Version Control
rDMS maintains detailed version history, allowing users to track and manage document revisions. This ensures the use of the most up-to-date and compliant versions.
Access Control
Robust access controls restrict document viewing and editing to authorized personnel, safeguarding sensitive regulatory information and complying with data privacy regulations.
Workflow Automation
rDMS streamlines document approval workflows, automating the routing of documents for review and approval. This ensures that regulatory documents adhere to prescribed processes and timelines.
Audit Trails
Comprehensive audit trails capture every action taken on a document, providing a clear record of who did what and when. This is an important feature in the rDMS that allows organizations to show their compliance during audits.
Collaboration Tools
rDMS offers features for real-time collaboration, facilitating concurrent editing, comments, and document sharing among regulatory teams and other stakeholders.
Change Control
Users can request document modifications through change control processes requiring approval before implementation. This ensures that changes align with regulatory requirements.
Search and Retrieval
Advanced search and indexing capabilities make it easy to find specific documents quickly, which is essential during audits or when responding to regulatory queries.
Compliance Tracking
rDMS provides tools for tracking and monitoring compliance with regulatory standards, deadlines, and obligations. Alerts and notifications help ensure proactive compliance management.
Reporting and Analytics
Robust reporting and analytics features enable organizations to assess document performance, compliance status, and workflow efficiency, supporting data-driven decision-making.
Integration
rDMS often integrates with other systems, such as electronic document management systems (EDMS), electronic lab notebooks (ELN), and regulatory information management systems (RIMS), to ensure seamless data exchange and reduce data duplication.
Secure Document Storage
rDMS employs secure data storage and backup mechanisms to protect regulatory documents from loss or damage, ensuring data integrity and availability.
Customer Success
CQ's software suite is meticulously designed to meet the highest regulatory standards. Our tools are pre-validated and fully compliant with GxP Guidelines, FDA 21 CFR Part 11, and ISO 13485:2016, ensuring the utmost quality and security.
Our regulatory document management is seamlessly integrated into our all-in-one Quality Management System (QMS) software, which encompasses essential modules like document control, change control, audits, non-conformances (NCs), Corrective and Preventive Actions (CAPA), supplier management, training, and more. We handle system implementation, provide comprehensive training, and offer ongoing support to guarantee the smooth operation of our software.
What sets us apart is our commitment to continuous re-validation, a service not commonly offered by other providers. We deliver robust validation evidence for audits and inspections, including validation plans, procedures, reports, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation.
Key features of CQ's Regulatory Document Management Tools encompass controlled document workflows, detailed version control and document history tracking, user access controls with permissions management, a complete audit trail of document changes, a centralized and cloud-based repository for easy document search and retrieval, compliant electronic signatures adhering to FDA 21 CFR Part 11, extensive support for various QMS processes, seamless integration with third-party software applications, and the flexibility to access documents from any device. Our software is tailored to meet your compliance and document management needs efficiently and effectively.
We went live with CQ just a few weeks ago and it works great! We received excellent training and after some playing around and getting used to it we found that it is really easy to use. So far we have implemented Document and Training Management as well as CAPA and both have everything we need right out of the box. After years of cumbersome spreadsheets and databases CQ is a blessing. It makes document management quick and easy… and it’s a pleasure to use.
Helen Cary,Document Control Specialist
Areas where Regulatory Document Management Software for Life Sciences is used
Risk mitigation
Regulatory Document Management plays a pivotal role in risk mitigation in the life sciences. Centralizing and automating document control ensures compliance with stringent regulations and standards. Document version control and audit trails offer transparency and accountability, reducing non-compliance risk. Controlled workflows and access controls limit errors and unauthorized access, enhancing data integrity. The ability to quickly retrieve documents and provide comprehensive evidence during audits minimizes regulatory risks. Integration with change control processes also helps proactively address quality issues, preventing potential compliance breaches.
Regulatory compliance
Regulatory Document Management is instrumental in achieving and maintaining regulatory compliance in life sciences. It centralizes all essential documents, ensuring they adhere to the latest industry standards and regulatory requirements. Document version control, comprehensive audit trails, and access controls guarantee data integrity and traceability, facilitating compliance with stringent regulations. Controlled workflows streamline document approvals and revisions, reducing the likelihood of errors. Moreover, swiftly locating and producing documents during audits or inspections supports compliance efforts.
Employee collaboration
Regulatory Document Management facilitates seamless collaboration among teams and stakeholders in the life sciences. It promotes effective communication and teamwork by offering real-time document sharing, editing, and commenting capabilities. This fosters the collective authoring, reviewing, and approval of critical regulatory documents, enhancing the efficiency of compliance processes. Furthermore, the system's centralized repository ensures that all stakeholders can access the most up-to-date documents, reducing the risk of inconsistencies. In an industry where compliance is paramount, Regulatory Document Management encourages collaboration by providing a secure, controlled environment for document collaboration, ultimately helping life science organizations meet their regulatory obligations more effectively.
ISO 9001 Internal Audit Checklist – Part B (Quality Manual, Document Control)
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