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Middle Office Platform
The only AI-powered Middle Office Platform that unifies PLM, QMS, EHS, and SRM into a single, intelligent solution
Product Lifecycle Management
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Design Process and Quality System Development Tools in Product Lifecycle
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Design Quality: Connecting Design to Documentation
Complaints Management
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
Document and Learning Management
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Manufacturing Challenges and Industry Trends Towards Digital Transformation
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Frost Radar for Quality Management Systems Names ComplianceQuest Leader
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The Ultimate Guide to Next-Generation Supplier Management [e-Book]
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Safety Essentials: Key ‘Must-have’ Components for Safety Management at Any Enterprise
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About
About ComplianceQuest
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 quality, safety and efficiency as they bring their products from concept to customer success.
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Document control software is a specialized tool designed to manage an organization's creation, approval, distribution, and tracking of documents.
It provides a centralized platform for storing and organizing documents, ensuring version control and access control. Document control software streamlines document workflows, automates approval processes, and tracks document revisions. It helps maintain document integrity, compliance with regulations, and consistency across the organization.
Documents are an essential part of every business and can take many forms. At any enterprise, documents can include contracts with suppliers, customers, employees, and guidelines for governance. Document Management and document control are absolutely critical from a quality management perspective. In fact, a robust, flexible, scalable document control software is the first step in the automation of quality processes and workflows using an EQMS.
Only with the right document control strategy can the quality processes within your organization be truly collaborative. It is at the core of compliance with FDA and ISO requirements, in addition to adherence to other compliance and regulatory requirements. Document control also plays an important in improving the efficiency of processes by enabling reliability and traceability of all quality control-related data and information.
In today’s digital era of quality management, a data-driven approach to building a quality culture within your enterprise is key. Your document control software is at the core of any data-driven EQMS system.
The document control procedure is a framework to determine how documents are approved, updated or amended, changes tracked, published, and made obsolete. It is a centralized system that helps in automating all the document control procedures that are defined by a Document Control Procedures Manual that delineates the method of:
In regulated industries such as life sciences and medical devices, the value of a world-class document management solution cannot be…
A leading specialty chemicals manufacturer was looking to replace an existing document control system, which was not working well. They…
Document control issues have plagued companies since paper was invented during early Egyptian civilization. Well, we don’t really have any…
Document Control Management Software delivers comprehensive tools and features to manage documents and records within an organization efficiently. It offers version control, ensuring that the latest document versions are accessible. It facilitates document creation, review, and approval processes, streamlining collaboration. This software typically provides secure storage, search and retrieval capabilities, and audit trails for compliance tracking. It often includes electronic signature capabilities for authorization. Additionally, it ensures document traceability and access control, enhancing data security. Document Control Management Software optimizes document workflows, reduces errors, ensures regulatory compliance, and centralizes document repositories, promoting data integrity and efficiency in various industries, including healthcare, manufacturing, and regulatory-driven sectors.
Document Control Software offers a range of capabilities and solutions that encompass various aspects of document management, scanning, collaboration, governance, and analytics.
Here are some of the key capabilities:
It may provide tools for visualizing data trends and patterns within documents. Reporting: Users can generate custom reports for auditing, compliance, and decision-making.
Even the best of tools and systems need wholehearted implementation of processes to achieve its purpose. We list below 4 Document Management Best Practices that you cannot do without:
To meet your document control needs that are aligned with your internal policies as well as compliant with regulatory requirements, you need a system that is intuitive, automated, easy-to-use as well as future-ready.
When you are looking for document control software, you must keep the following in mind:
ComplianceQuest Document Control Software is designed to streamline and automate the document management process, ensuring regulatory compliance and efficient handling of documents within an organization. Here's an overview of how ComplianceQuest Document Control Software works:
Document Creation and Capture
The software allows users to create or import new documents. Documents can be created using built-in templates or customized formats.
Version Control
ComplianceQuest maintains a centralized repository where all documents are stored. It tracks versions and revisions of each document, ensuring that the most up-to-date version is accessible and easily identifiable.
Document review and approval
The software facilitates collaboration and review processes by providing tools for document routing, assigning reviewers, and setting up approval workflows. It allows multiple stakeholders to review and comment on documents electronically, ensuring efficient collaboration.
Document Distribution
Once a Document is approved, ComplianceQuest enables easy distribution to relevant individuals or teams. It ensures authorized users access the appropriate documents while maintaining Security and access controls.
Document Retrieval and Search
The software offers robust search functionality, enabling users to locate specific documents or information within the repository quickly. It supports advanced search filters, metadata tagging, and full-text search capabilities.
Document Change Control
ComplianceQuest tracks all document changes, including revisions, updates, and modifications. It maintains an audit trail of document history, providing transparency and accountability for compliance purposes.
Document Archival and Retention
The software facilitates the organization's document retention policies, ensuring that documents are retained for the required duration and automatically archiving or disposing of documents when necessary.
Compliance and Audit Support
ComplianceQuest Document Control software helps organizations comply with industry regulations and standards. It provides robust Reporting capabilities and generates compliance-related metrics and analytics. It also assists during audits by providing easy access to required documents and demonstrating adherence to compliance guidelines.
Once a Document is approved, ComplianceQuest enables easy distribution to relevant individuals or teams. It ensures authorized users access The appropriate documents while maintaining Security and access controls.
By implementing the ComplianceQuest Document Control software, you can reap the following benefits:
Automate Document Management Workflow:
Right from creating new documents to classifying and storing them in a central repository, ComplianceQuest Document Management takes care of the entire workflow. Approvals, reviews, and change management are also automated. This ensures a single version of the truth that can be easily identified and cross-referenced.
Reduce Costs:
With automation, document storage, retrieval, and access have become simple and easy, resulting in cost and time efficiency. According to a Deloitte study, a large retail bank was able to reduce processing costs by as much as 25% by going paperless.
Better Security:
The documents need to be accessed as per your internal data governance and data security policies. ComplianceQuest ensures that sensitive documents are accessed only with appropriate authentication and authorization.
Compliance:
Document control is a mandatory requirement under ISO 9001 and FDA. Other federal and state regulatory regulations such as Sarbanes Oxley and HIPAA also require compliance with their guidelines and penalize non-conformance with fines, revoked licenses, and even criminal liability at times.
Audit Management:
ComplianceQuest Document Management System also enables an audit trail detailing when a document was viewed last, by whom, and modifications, if any. During inspections and audits, the documents can be retrieved and shared easily.
Better Collaboration:
An enterprise-wide document management system like ComplianceQuest lets disparate teams access the same document with greater ease. Sharing, reviewing, approvals are better managed over an automated data control system.
Business Continuity and Disaster Recovery:
ComplianceQuest Document Control Software is cloud-based, built on the robust Salesforce.com. As a result, even during disasters – man-made and natural – your documents will remain safe and highly traceable.
Improved Productivity:
Automated document control software frees up your resources to focus on more critical functions and improve their productivity as well as the efficacy of the processes. Enjoy greater flexibility and scalability with a cloud-based document management software such as the one from ComplianceQuest that is future-ready and can protect your investments.
Customer Success
The ComplianceQuest solution offers a range of advanced features essential in today's interconnected world.
The document control solution provides robust Security features that allow you to define access controls based on your internal data governance policies. you can assign specific rights for viewing, modifying, or distributing documents, ensuring strict Security privileges.
The Search/Library Management feature of ComplianceQuest Document Management enables easy Document retrieval. you can perform full-text searches, navigate through folders, and use tags for keyword searches, making Document location a breeze.
Collaboration is seamlessly facilitated across the enterprise, allowing for feedback from the supply chain without compromising ownership of tasks.
ComplianceQuest's mobile-ready Document Control software lets you access your QHSE solution anytime, anywhere, and on any device. This ensures business continuity, as you can pull up reports, approvals, record views, reviews, and alerts while on the go, improving efficiency, visibility, and flexibility.
The document control solution also offers powerful Reporting and Analytics capabilities. you can use pre-developed report templates based on best practices or create custom reports and dashboards to make informed decisions quickly.
Like and follow relevant records to stay updated using your credentials and receive an email, dashboard, or mobile notifications.
The Document Comparison feature provides a highly graphical view, allowing approvers, reviewers, and learners to identify changes from The previous version easily. This streamlines The review and approval process, enabling learners to focus on understanding the impact of the changes.
Seamless integration with Office 365 further enhances collaboration between authors, reviewers, and subject matter experts. Whether working concurrently or sequentially, you can capture document content mark-ups and comments as part of the content review workflow.
The solution provides robust Security features that allow you to define access controls based on your internal data governance policies. you can assign specific rights for viewing, modifying, or distributing documents, ensuring strict Security privileges.
Collaboration is seamlessly facilitated across The enterprise, allowing for feedback from The supply chain without compromising ownership of tasks.
The solution also offers powerful Reporting and Analytics capabilities. you can use pre-developed report templates based on best practices or create custom reports and dashboards to make informed decisions quickly.
The Document Comparison feature provides a highly graphical view, allowing approvers, reviewers, and learners to identify changes from The previous version easily. This streamlines The review and approval process, enabling learners to focus on understanding The impact of The changes.
CQ's Document Control Software is a comprehensive solution to streamline document management processes and enhance organizational effectiveness. With its advanced features and intuitive interface, the software enables efficient document creation, control, collaboration, and tracking. With ComplianceQuest's Document Control Software, organizations can effectively manage their document lifecycles, ensure compliance with regulations, enhance collaboration, and improve overall operational efficiency.
CQs Document control software without a doubt makes your entire document management process smooth. However, that’s not all. It is also a regulatory requirement. For instance, the FDA requires you to conform to 21 CFR 11.10(k): Document Control if you use regulated computer systems. It expects your system to enable document approval, revision, and storage as well as follow a defined set of procedures for the use and administration of the computer system itself.
ISO 9001:2015 also lays down guidelines for document control that spans:
The ComplianceQuest Data Control Solution has been created to align closely with ISO and the other regulatory requirements and therefore, you can be sure of compliance. Any change in the regulations is also instantly reflected in the solution, making it easy for your enterprise to keep pace. As every region has its own set of regulations, CQ ensures that various locations within your enterprise are also automatically in line with data privacy and other location-specific requirements.
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
Document Control Software plays an important role in a highly regulated industry. Although meeting compliance is one of the primary uses of a document control software, it plays an important role in quality management as it helps.
Medical Device Document Control Software is a specialized software solution designed to manage, organize, and control the vast array of documents and records associated with medical device development, manufacturing, and regulatory compliance. It streamlines document creation, review, approval, and distribution processes, ensuring all documents meet regulatory requirements and industry standards such as ISO 13485.This software provides version control, audit trails, electronic signatures, and secure storage, enabling efficient collaboration and reducing the risk of errors or compliance issues. It helps medical device companies maintain data integrity, traceability, and adherence to Quality Management Systems, ultimately enhancing product safety and regulatory compliance.
ComplianceQuest Medical Device Document Control Software has become increasingly popular due to the unique needs and challenges of the medical device industry.
Several factors contribute to its popularity:
ISO 9001 Internal Audit Checklist – Part B (Quality Manual, Document Control)
Checklist | May 15th, 2023
Are My Design and Development Changes Documented Adequately – Let’s Check!
Checklist | August 17th, 2022
Laboratory Records and Documentation – Ultimate Checklist
Checklist | July 12th, 2022
Eight Steps Toolkit to comply Technical Documentation for EU MDR
Checklist | April 20th, 2021
Yes, all three serve the same objectives and are used interchangeably to refer to the same platform.
Definitely, the volume of documents may be less for a smaller organization. But as you grow, so will the number of documents and a well-designed document control software can help you manage it efficiently.
A cloud-based document management software provides you with the functionalities for a range of document control actions like creation, storing, revision, searching, and collaboration. A cloud storage space, on the other hand, is a space on the cloud where you can store your documents, much like a local hard drive or file storage space.
No, apart from electronic files, your document control software can also store your paper documents by scanning them and storing them on the cloud.
By using APIs, or application programming interfaces, the document control software allows for customised integration. It can also work with your ERP and CRM, and it features integrations with Microsoft Office, Salesforce, Box, DocuSign, QuickBooks, and similar programs.
Being stored on a cloud offsite, your documents are safe. Since ComplianceQuest also provides a mobile-ready solution, you can access it from anywhere, anytime.
At ComplianceQuest, we recently published a whitepaper titled ‘Safety Control…
The way a company communicates with regulatory bodies – be…
Document control issues have plagued companies since paper was invented…
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