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Document Control Software

CQ Document Control Software


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Document Control Software – For Document Lifecycle Management

A DATA-DRIVEN APPROACH TO BUILDING A QUALITY CULTURE WITHIN YOUR ENTERPRISE

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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.

What is Document Control Software?

A document control software such as the one from ComplianceQuest enables the management of documents right from:

  • Creation
  • Revision
  • Distribution
  • Accessibility

The two main requirements in the document management lifecycle are reliability and trust. The software helps automate the document creation and management process and makes document control simple and easy.

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Document control software

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

Benefits of CQ’s Document Control Software

By implementing the ComplianceQuest Document Control system, you can reap the following benefits:

  • Automate Document Management Workflow: Right from creating new documents to classifying and storing them in a central repository, ComplianceQuestions 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.

How CQ’s Document Control Software Works

ComplianceQuest’s Document Control Software automates the documentation workflow and has modules aimed at providing a smooth experience right from the time of creating it to making it obsolete. It also enables ease of collaboration among team members and other stakeholders. The workflow is captured in its modules:

Creation and Categorization

  • The ComplianceQuest Document Management solution simplifies the document creation process as well as revising the existing ones.
  • A central repository helps you store and organize your documents based on various templates and classification criteria.
  • Pre-approved templates available in the solution makes the creation of relevant documents in the right template easy.
  • Creating an association between related documents makes for quick and easy identification and cross-referencing.

Review and Approvals

  • The ComplianceQuest Document Management Solutions software ensures timely and consistent review and approval of documents through email notifications and reminders. Imitating the organization’s best practices.
  • CQ-DOC also enables approval workflows based on sequential, parallel, or combination review.

Release Management

  • You can automate or manually release approved documents based on predefined ‘effective dates’ criterion using the ComplianceQuest Document Management Solutions software.
  • The solution also automatically initiates processes such as the conversion of the native Office format document to PDFs for restricted viewing by end-users and notifies employees about training.

Document Training

  • ComplianceQuest Document Management Solutions software enables the easy identification of Job Functions requiring training.
  • When a new document is issued or an existing one revised, all those requiring training based on their job function(s) will be automatically notified.
  • Training Coordinators can also ensure training in a timely manner by using the solution to track who has viewed, read and signed-off and who is left.

Revision And Periodic Reviews

  • The software records the revision history for each document.
  • You can set review periods or obsolescence rules for all documents to ensure timely review and compliance with internal policies.

Change Management

Documents change processes such as requests, reviews, incorporation, and closure of the change associated with them can be managed well with the ComplianceQuest Document Management Solutions software.

Relation with FDA and ISO Requirements

Document control 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:

  • ISO 9001
    Approval for adequacy before being issued
  • ISO 9001
    Review, update, and re-approval as needed
  • ISO 9001
    Changes and current revision status to be identified
  • ISO 9001
    Relevant versions of applicable documents should be made available appropriately
  • ISO 9001
    They should be legible and easily identifiable
  • ISO 9001
    The external origin of the documents should be identified and their distribution controlled
  • ISO 9001
    Prevention of obsolete documents being used unintentionally
  • ISO 9001
    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.

Relation with FDA and ISO Requirements

Document control 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.

Advanced Features of CQ’s Document Control Software

Besides the document creation and associated workflows, the ComplianceQuest solution also offers several advanced features that are a must in today’s connected world.

  • ISO 9001
    The first and foremost is Security that you can define based on your internal data governance policies to control and monitor the access to specific content. Assign rights to view, modify, or distribute documents based on security privileges.
  • ISO 9001
    The Search/Library Management feature of ComplianceQuest Document Management facilitates the easy location of documents. You can do a full-text search or navigate folders. Keyword search is also enabled through the tags capability.
  • ISO 9001
    Collaboration is made possible across the enterprise as also seeking feedback from the supply chain without giving up ownership of the tasks.
  • ISO 9001
    You can access your QHSE solution from anywhere, anytime, and on any device. ComplianceQuest Document Control is mobile-ready, letting you pull up reports, approvals, record views, reviews, alerts, etc., to ensure business continuity even when you are on the go, thereby improving efficiency, visibility, and flexibility
  • ISO 9001
    Reporting and Analytics: Utilize pre-developed report templates developed based on best practices. You can also create additional reports and dashboards based on your needs and make informed decisions quickly
  • ISO 9001
    Like and Follow relevant records in the system using your credentials. You can also sign up for notifications via email, dashboard, and mobile
  • ISO 9001
    Approvers, reviewers, and learners (all employees) can see what has changed from the previous version using the Document Comparison feature in a highly graphical view. This can help quicken the reviews and approval process. Learners can focus on the changes to understand the impact of the changes.
  • ISO 9001
    The seamless integration to Office 365, Controlled Document system facilitates collaboration between authors, reviewers, and their peers or other subject matter experts either concurrently or sequentially. You can capture document content mark-ups or their comments easily and as part of the content review workflow

Best practices of Document Control system

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:

4 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

 

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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:

  • ISO 9001
    The file structure that is easy for users to understand and use.
  • ISO 9001
    Search facility with advance filters to easily locate files based on the name, content, date modified, file type, and other filters.
  • ISO 9001
    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.
  • ISO 9001
    Mobile readiness to enable the traveling executive access documents.
  • ISO 9001
    Ensuring the security of sensitive data and documents to meet regulatory requirements and protect your stakeholder. Set access permissions based on roles and needs.
  • ISO 9001
    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.
  • ISO 9001
    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.
  • ISO 9001
    To make corrections and revisions easy, the software should have an editing tool as well.
  • ISO 9001
    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.

Keeping Documents Within Easy Reach

The ComplianceQuest Document Control Software is a comprehensive solution for automating document management across the enterprise. Apart from providing the key document management functions, it also includes analytics and reporting capabilities with intuitive dashboards to help you track each document from origin to obsolescence, providing complete visibility into the document control process.

Frequently Asked Question

Does a small business need a document management system?
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.
Are document management systems, document management software, and document management solution the same?
Yes, all three serve the same objectives and are used interchangeably to refer to the same platform.
Is cloud storage the same as cloud-based document management systems?
In the case of cloud storage, you acquire space on a cloud to store your documents. It is like a local hard disk, just a storage space for files. A cloud-based document management system, on the other hand, provides you with functionalities for a range of document control actions – creating, storing, revisions, search and collaboration.
Is document management only for electronic documents?
No, apart from electronic files, your document control software can also store your paper documents by scanning them and storing them on the cloud.
Can a document management system work with other programs the organization uses?
By using APIs or application programming interface, the Document Control Software allows for customized integration. It also can work with your ERP and CRM and it features integrations with Microsoft Office, Salesforce, Box, DocuSign, QuickBooks, and similar programs.
What happens in case of a disaster? Will my documents be safe?
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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