Document Control Software

Document Control Software

document control software

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.

document control software

Document Control Software Overview

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.

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What are Document Control Procedures?

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:

  • Creating the document, its formatting, naming, and other technical details.
  • Reviewing, approvals, and recording the approvals and modifications.
  • Identifying when a document needs revision, initiating or requesting revisions, determining who can implement them, and set the approval process in motion.
  • Defining the parameters for publishing a document, its location, providing access based on authorization, determining who can access it, and establishing the security restrictions.
  • Establishing the validity period of the document based on the date or its content, making it obsolete, and removing it is also an important part of the document control procedure.
ComplianceQuest document control software

What does Document Control Management Software Deliver?

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 Management Software
  • Capabilities of Document Control Software

    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:

      • Document Storage: It provides secure, organized, and easily accessible storage for documents and records.
      • Search and Retrieval: Users can efficiently locate and retrieve specific documents, enhancing productivity.
      • Security and Access Control: Document access is controlled, protecting sensitive information.
      • Audit Trails: It maintains detailed records of document changes and access for compliance and accountability.
      • Document Storage: It provides secure, organized, and easily accessible storage for documents and records.
      • Scanning: The software allows for digitizing physical documents, making them accessible in digital formats.
      • OCR (Optical Character Recognition): It converts scanned text into machine-readable text, enabling searchability within scanned documents.
      • Data Capture: It extracts and stores important data from scanned documents for easy retrieval and analysis.
      • Collaboration Tools: Document control system software often includes features for real-time collaboration, enabling teams to work together on documents remotely.
      • Document Sharing: It facilitates secure document sharing within and outside the organization.
      • Commenting and Annotation: Users can provide feedback and make notes directly on documents.
      • Compliance Management: The software helps organizations adhere to industry regulations and standards by ensuring document compliance.
      • Lifecycle Management: It manages the entire document lifecycle, from creation to archival or disposal.
      • Policy Enforcement: Ensures that documents and records adhere to the organization's information governance policies.
      • Analytics Tools: Document control system software may include analytics capabilities to gain insights into document usage, access, and changes.
    • It may provide tools for visualizing data trends and patterns within documents. Reporting: Users can generate custom reports for auditing, compliance, and decision-making.

    Document Control System Software Capabilities

Best Practices of Document Control Software

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:

document control software best practices

  • Establish Ownership: Accountability is important for your document control effort to succeed. Even if a team or committee of people is involved, empower an individual to lead the effort and establish practices, set up his team, and organize funding. This will improve compliance with internal policies as well as external legal and regulatory requirements.

  • Document Retention Policy: The period for which a document should be retained should be clearly specified and be aligned with regulatory requirements. Legal and operational concerns are the other factors important to establish the duration.

  • Involve the Users: It is important to communicate the objectives and expected results of the document management efforts with every employee. Only a collaborative effort with each employee contributing to the process can have the desired effect.

  • Make the Document Management System Secure: Your documents are your assets and should be protected from unauthorized access internally as well as externally. Role-based authorization is essential to protect the documents and sensitive data.
Control or Mess

Control or Mess – Where’s My Document?

What to Look for in a Document Control Software?

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:

  • The file structure that is easy for users to understand and use.
  • Search facility with advance filters to easily locate files based on the name, content, date modified, file type, and other filters.
  • Cloud storage and connectivity to future proof your investment in the document control software, reduce your infrastructure and maintenance costs and accessibility from anywhere with appropriate security.
  • Mobile readiness to enable the traveling executive access documents.
  • Ensuring the security of sensitive data and documents to meet regulatory requirements and protect your stakeholder. Set access permissions based on roles and needs.
  • Integration with other programs such as email and customer relationship management software is important for notifications, alerts, and access to data important for document management.
  • Since you will also have physical documents, a good Document Management Software should include scanning facilities so that those documents are part of your central hub as well.
  • To make corrections and revisions easy, the software should have an editing tool as well.
  • Document version control is an essential part of document management for regulatory needs as well as for your operational purposes. Tracking changes along with the time and by who information should be captured to have a complete view of the document’s progress over time.

How CQ’s Document Control Software Works?

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:

creation and categorization

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.

review and approval process

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.

release management

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 training

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.

  • revision history

    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.

    change management

    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.

    change management

    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.

    change management

    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.

    • creation and categorization

      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.

    • review and approval process

      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.

    • release management

      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 training

      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.

    • revision history

      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.

    • change management

      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.

    • change management

      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.

    • change management

      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.

    Benefits of CQ’s Document Control Software

    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.



    2 companies leveraging CQ document management solution case study

    Customer Success

    Success Story of 2 Companies Leveraging CQ Document Management Solution to Optimize their Business Processes

    2 companies leveraging CQ document management solution case study
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    Advanced Features of CQ’s Document Control Software

    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.

    Document Control Software features
    • 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.

    • 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 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.

    Keeping Documents Within Easy Reach

    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.

    Document control software to ensure FDA and ISO requirements

    Ensuring FDA and ISO requirements with CQ's document control software

    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:

    • Approval for adequacy before being issued
    • Review, update, and re-approval as needed
    • Changes and current revision status to be identified
    • Relevant versions of applicable documents should be made available appropriately
    • They should be legible and easily identifiable
    • The external origin of the documents should be identified and their distribution controlled
    • Prevention of obsolete documents being used unintentionally
    • Obsolete documents that are retained for a specific purpose, to be suitably identified

    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.

    CQ Works Great and is a Pleasure to Use

    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

    Lin Engineering logo
    Lin Engineering logo

    Role of Document Control Software in Quality Management

    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.

    • Create a better access control
    • Allow transparency of information
    • Enable collaboration among colleagues from anywhere
    • Increase efficiency with better processes in place for approval and access
    • Ensure better data security
    document control software role in quality management
    Medical Document Control Software

    Medical Device Document Control Software

    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.

    What Makes ComplianceQuest Medical Device Document Control Software Popular?

    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:

    ComplianceQuest Medical Device Document Control Software

    • Regulatory Compliance: The medical device sector is highly regulated, with stringent requirements imposed by agencies like the FDA and ISO. Document control software ensures companies can effectively adhere to these regulations, reducing compliance risks and facilitating audits.
    • Data Integrity: Ensuring documentation’s accuracy, security, and integrity is critical in medical devices. Document control software offers features like version control, audit trails, and access control to maintain data integrity and prevent errors or unauthorized access.
    • Efficiency: The software streamlines document workflows, reducing manual, paper-based processes and cumbersome record-keeping. This efficiency saves time and cost, enabling organizations to bring products to market more quickly.
    • Collaboration: Collaboration tools within the software enable geographically dispersed teams to work on documents together, facilitating efficient document reviews and approvals. This is especially important in an industry that often involves multiple stakeholders and experts.
    • Traceability: The software allows easy document changes, approvals, and access history tracking. This traceability is crucial for demonstrating accountability and compliance with quality standards.
    • Document Security: Given the sensitive nature of medical device information, robust security features within the software help protect confidential data from breaches and unauthorized access.
    • Audit Preparedness: With audit trails and comprehensive documentation, the software helps companies be well-prepared for regulatory inspections and audits.
    • Remote Access: In a world where remote work is increasingly common, accessing and collaborating on documents from anywhere is a significant advantage.
    • Competitive Advantage: Companies using advanced document control software can streamline their processes, reduce errors, and bring innovative medical devices to market faster, giving them a competitive edge in a highly competitive industry.

    Automating document management across the enterprise to increase visibility, improve security, and reduce cost with CQ's robust, flexible, and scalable document control software

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    Quality-centric Companies Rely on CQ QMS

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    • lifescan mono
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    • impossible mono
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    Frequently Asked Questions

    • 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.

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