Document Management  >  Document Control System

Document Control System

document control system
document control system
what is a document control system

What is Document Control?

Document control is defined as a series of practices that ensure that documents are created, assessed, distributed, and disposed of in a secure and efficient way. Thus, you can improve the efficiency of processes by enabling the reliability and traceability of all quality control-related data and information.


What is a Document Control System?

A document control system is a process of managing documents from the point of creation to distribution and storage throughout the lifecycle. A document control system helps your organization to reduce overhead costs and save time by automating manual, paper-based processes.

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How does a Document Control System help in Documentation for Regulated Products?

In highly regulated industries, a document control system facilitates businesses with access to all the records and documents needed to prove compliance. With the help of document control, you can ensure that your documentation is traceable, accurate, organized, reportable, and complies with any legal or regulatory standards. Documentation for regulated products is essential to prove the dependability, reproducibility, repeatability, safety, and effectiveness of your organization’s processes. With proper documentation, you can understand what must be done, when it must be done, and how it must be done.

how document control system help in documentation for regulated products

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Importance of Document Control System in a Regulated Environment

A document control system plays a significant role in a regulated environment. Its importance lies in:

robust access control to sensitive documents

#1: Robust Access Control to Sensitive Documents

In highly regulated industries, security breaches are a serious risk, and a password-protected spreadsheet can’t help keep unwanted eyes away. A document control system allows you to control who has access to specific files so that only the right people have permission to view, edit, and delete documents to mitigate the risk of information leakage.

enhanced compliance

#2: Enhanced Compliance

Document control can help you to comply with regulatory and quality systems (QS) within FDA, ISO, EU, and more for electronic signatures and passwords. Inefficient document control systems can cause warning letters from the FDA and other regulatory agencies. An effective document control system can help you to minimize the risks of unfinished documentation, improper forms with signatures, or infrequent audit trails.

protect sensitive data

#3: Protect Sensitive Data

Document control systems play a huge role in identity and access management, protecting sensitive documents from exposure to prying eyes. They can help authorized parties quickly search, find, and retrieve archived and active documents by simplifying access when needed. Document control systems offer an exceptional user experience (UX) by providing transparency and control of information that can mitigate regulatory risks and improve productivity compared to paper-based systems.

better collaboration

#4: Better Collaboration

In highly competitive industries, paper-based approaches to document control delayed the review of documents significantly. Today, cloud-based software for document control systems can enable real-time collaboration between a distributed, more efficient, connected, and aligned workforce with simple access from desktop computers or mobile devices.

improved quality management

#5: Improved Quality Management

Quality management systems are an important component of compliance and quality-driven culture in highly regulated industries. Document control can increase efficiency with smarter processes for approval, document storage, and access, along with adhering to cGMP for SOPs, organizational policy, and other essential quality processes.

recover loss

#6: Recover Loss

Paper-based documents can easily be lost, stolen, or destroyed, which can cause significant risks to effective business continuity. A document control system provides you with a central repository to keep important documents, records, and reports and prevents the loss of institutional knowledge. Thus, an organization can quickly recover from threats to data security.

scalability

#7: Scalability

The scalable document control system can offer huge business benefits, including:

  • Provide organizational agility by accessing and editing documents.

  • Improve company valuation with an effective document control system and a quality-driven culture.

  • Offer streamlined workflows and transparency that can simplify processes for individuals at every level of the organization.

  • robust access control to sensitive documents

    #1: Robust Access Control to Sensitive Documents

    In highly regulated industries, security breaches are a serious risk, and a password-protected spreadsheet can’t help keep unwanted eyes away. A document control system allows you to control who has access to specific files so that only the right people have permission to view, edit, and delete documents to mitigate the risk of information leakage.

  • enhanced compliance

    #2: Enhanced Compliance

    Document control can help you to comply with regulatory and quality systems (QS) within FDA, ISO, EU, and more for electronic signatures and passwords. Inefficient document control systems can cause warning letters from the FDA and other regulatory agencies. An effective document control system can help you to minimize the risks of unfinished documentation, improper forms with signatures, or infrequent audit trails.

  • protect sensitive data

    #3: Protect Sensitive Data

    Document control systems play a huge role in identity and access management, protecting sensitive documents from exposure to prying eyes. They can help authorized parties quickly search, find, and retrieve archived and active documents by simplifying access when needed. Document control systems offer an exceptional user experience (UX) by providing transparency and control of information that can mitigate regulatory risks and improve productivity compared to paper-based systems.

  • better collaboration

    #4: Better Collaboration

    In highly competitive industries, paper-based approaches to document control delayed the review of documents significantly. Today, cloud-based software for document control systems can enable real-time collaboration between a distributed, more efficient, connected, and aligned workforce with simple access from desktop computers or mobile devices.

  • improved quality management

    #5: Improved Quality Management

    Quality management systems are an important component of compliance and quality-driven culture in highly regulated industries. Document control can increase efficiency with smarter processes for approval, document storage, and access, along with adhering to cGMP for SOPs, organizational policy, and other essential quality processes.

  • recover loss

    #6: Recover Loss

    Paper-based documents can easily be lost, stolen, or destroyed, which can cause significant risks to effective business continuity. A document control system provides you with a central repository to keep important documents, records, and reports and prevents the loss of institutional knowledge. Thus, an organization can quickly recover from threats to data security.

  • scalability

    #7: Scalability

    The scalable document control system can offer huge business benefits, including

    • Provide organizational agility by accessing and editing documents

    • Improve company valuation with an effective document control system and a quality-driven culture

    • Offer streamlined workflows and transparency that can simplify processes for individuals at every level of the organization.

Features of CQ Document Control System

ComplianceQuest offers numerous advanced features along with the document creation and associated workflows, such as

  • Security:

    Security can be defined based on your internal data governance policies to control and monitor the access to specific content. An organization must assign rights to view, modify, or distribute documents based on security privileges.

  • Search or Library Management:

    This feature of ComplianceQuest’s centralized Document Management facilitates you to do a full-text search or navigate folders. The keyword search feature is also enabled through the tags capability.

  • Collaboration:

    Collaboration can be made possible across the enterprise by seeking feedback from the supply chain without giving up ownership of the tasks.

  • Mobile-Enabled:

    Being mobile-enabled, ComplianceQuest Document Control can be accessed from anywhere, anytime, and on any device. This can help you to pull up reports, approvals, record views, reviews, alerts, etc., to ensure business persistence. Thus, you can improve efficiency, visibility, and flexibility.

  • Reporting and Analytics:

    You can create additional reports and dashboards based on your needs and make informed decisions quickly using pre-developed report templates based on document management practices.

  • Like and Follow:

    You can sign up using your credentials to get relevant records in the system and notifications via email, dashboard, and mobile.

  • Document Comparison:

    Document Comparison feature can help all employees, including approvers, reviewers, and learners, to see what has changed from the previous version. Thus, you can speed up the reviews and approval process. Besides, learners also can understand the impact of the changes.

  • Seamless Integration:

    The seamless integration to Office 365, the Controlled Document system facilitates collaboration between authors, reviewers, and other subject matter experts. You can capture document content mark-ups or their comments as part of the content review workflow.

Control or Mess

Control or Mess – Where’s My Document?

difference between document control system & document management system

Difference between Document Control System & Document Management System

The document control system is the security and credibility aspect of maintaining your documents. This keeps tabs on the current and previous versions of your documents. The document control process also involves:

  • Keeping document security
  • Enhancing document version control
  • Assessing documents
  • Implementing and maintaining an approval process
  • Handling document submission

These can help businesses to maintain a record of which documents they have used in the past and who has had access to them. Document control is all about automating your document handling and keeping track of all your essential documents with minimum effort for businesses of all shapes and sizes.

The Document Management system has become an essential part of modern-day businesses and involves digitizing paper documents, storing, validating, indexing, and updating them. Nowadays, every business focuses on digitizing its paper documents and maintaining a system for all future documents.

A controlled document is one of the aspects of document management that assures the security of the documents, while document management has become comparatively easy because of document handling systems.

How does Document Control System help Small Businesses as well as Large Enterprises?

A document control system can provide several benefits for enterprises of all types and sizes, such as,

  • Provides Access Control:

    A document control system can help you to avoid security breaches, information leakage, and data exposure, which are serious risks to a business and its reputation. A document control system allows users with permission to view, edit, and delete documents.

  • Improved Compliance:

    A document control system can help you comply with regulatory requirements for document management. Organizations will get warning letters from regulatory agencies due to a poor document control system.

  • Working Remotely and Global Collaboration:

    Being cloud-based, a document control system can allow you to work remotely with having access to the documents anytime, anywhere. This also promotes global collaboration between a workforce.

  • Streamline and Simplify Workflows:

    A cloud-based, centralized document control system can simplify and streamline workflows at every level of an organization. This can also help create a quality-driven culture and competitive advantage and enable the editing of documents easily.

  • Enables Transparency and Efficiency:

    A document control system ensures there is transparency with the help of identity and access management. Documents are easily searchable, organized, and up-to-date, so you don’t need to invest time in searching for the necessary documents to complete a task.

  • Improved Sustainability:

    A digital document control system can help you to save the cost of purchasing paper by going paperless, as well as store, shred, print, and dispose of it. Therefore, you can enhance the effort of sustainability.

  • Recover Damages and Disasters:

    A document control system can provide secure digital copies of your files in a centralized location to recover from a threat to data security. Thus, they can prevent damages and disruptions.

  • Provides Access Control:

    A document control system can help you to avoid security breaches, information leakage, and data exposure, which are serious risks to a business and its reputation. A document control system allows users with permission to view, edit, and delete documents.

  • Improved Compliance:

    A document control system can help you comply with regulatory requirements for document management. Organizations will get warning letters from regulatory agencies due to a poor document control system.

  • Working Remotely and Global Collaboration:

    Being cloud-based, a document control system can allow you to work remotely with having access to the documents anytime, anywhere. This also promotes global collaboration between a workforce.

  • Streamline and Simplify Workflows:

    A cloud-based, centralized document control system can simplify and streamline workflows at every level of an organization. This can also help create a quality-driven culture and competitive advantage and enable the editing of documents easily.

  • Enables Transparency and Efficiency:

    A document control system ensures there is transparency with the help of identity and access management. Documents are easily searchable, organized, and up-to-date, so you don’t need to invest time in searching for the necessary documents to complete a task.

  • Improved Sustainability:

    A digital document control system can help you to save the cost of purchasing paper by going paperless, as well as store, shred, print, and dispose of it. Therefore, you can enhance the effort of sustainability.

  • Recover Damages and Disasters:

    A document control system can provide secure digital copies of your files in a centralized location to recover from a threat to data security. Thus, they can prevent damages and disruptions.



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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How does a Document Control System work?

Document control system help businesses store, capture, sort, retrieve, and distribute documents. This follows a specific sequence of stages, including:

  • Document Capture Process: The document management process helps an organization capture, scan, and organize all the documents into one centralized repository. The major intent of the document capture process is to have prompt access to the required data by capturing all files from any source.
  • Document Classifying Process: After the document capture process, the next step is the document classifying process. In this process, you can index all files and classify them according to certain criteria like the number of orders, document type, vendor’s name, etc. Thus, employees can significantly reduce the time and effort spent on file search with the help of the Document Management System.
  • Document Storage Process: The following stage is the document storage process, where the Document Management System can help to save all the documents in a database. Documentation can be stored in two locations, namely on-premise and cloud-based. In an on-premise document management system, you don’t need an internet connection. A cloud-based document management system usually connects online for the security, maintenance, and backup creation of your documentation.
  • Retrieval & Distribution Processes of Document: Document indexing or classifying process helps to streamline the retrieval of files to help you find a required file immediately. The document management software enables you to distribute it among vendors, your employees, etc., by using either email or other methods of the file transfer.
how document control system work

Why is Cloud-based Document Control System a boon for Document Controllers?

A cloud-based document control system is a boon for document controllers because of the following aspects:

structured content
Structured Content

A cloud-based document management control system helps you easily find what you are searching for and gain access to metadata templates and revision control.

designed projects & deliveries
Designed Projects & Deliveries

A cloud-based document management control system helps you to set due dates and assign responsibilities, create project schedules, and re-use them as templates.

effective work processes
Effective Work Processes

A document management control system helps you to manage your review and approval process.

cooperate with external users
Cooperate With External Users

With the help of a document management control system, you can use a single data source for all of your communication and assign who has access to what.

controlled progress
Controlled Progress

With the help of a document management control system, you can use standard dashboards and reports, track milestones, and gain detailed tracking capabilities.

manage revision handling
Manage Revision Handling

With the help of a document management control system, you can manage revision handling and structure deliveries based on the right coding and numbering.

audit-ready data
Audit-Ready Data

Audit-ready data can help you to control your documents and processes completely, tracking who has viewed your data.

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

8 Reasons to choose Cloud-based Document Control System

8 reason to choose document control system

Choosing a cloud-based document control system will be beneficial for your organization because

  • Minimized Cost: A document control system can significantly minimize the operational costs related to lost documents, regulatory violations, paper, and other resource waste, as well as reduce common data entry errors.

  • Automated Workflow: A document control system can prevent the pain points connected with discrete workflows by digitizing critical documents within a document management system. By digitizing the documents and moving them into an electronic workflow, your organization can set up access levels, keep detailed audit trails, monitor user activity, and manage a document repository.

  • Improved Collaboration: With the help of a document control system, you can track and view audit trails that record who made an edit and when. So, these electronic documents can be shared as a secure link so that collaboration just happens with one click.

  • Advanced Search: A robust, digital document control system keeps all the documents that are captured and saved with metadata and indexing. Therefore, anyone can perform an advanced search when they need to locate any data.

  • Minimizes Storage Space: As modern digital document control systems store documents in the cloud, there is no need for costly file cabinets, boxes, storage bins, or oversized desks. This also helps you to manage a paperless, automated workflow to improve business efficiencies.

  • Retrieve Easily: With the help of advanced search functions, a document control system can retrieve documents easily and quickly.

  • Maximized Security: A document control system can help an organization with established security protocols to protect the integrity and confidentiality of business data.

  • Damage Recovery: A document management control system will help protect your company’s valuable data and promote advanced damage recovery efforts to maintain business continuity even during disasters.

Document Control Best Practices

There are 4 Document control practices for the implementation of processes to achieve their purpose involving:

Determine Ownership:

An organization should empower an individual to lead the effort and set up effective document practices, build his team, and plan to fund. This will comply with internal and external policies along with regulatory requirements.

Document Retention Practice:

Document Retention Practice refers to the duration for which a document should be retained and lined up with regulatory guidelines.

Collaborative Effort:

Collaborative effort is vital to understand the objectives and desired results of the document management efforts with every employee to get the desired effect.

Secure Document Management System:

Your documents should be secured from unauthorized access both internally and externally. With the help of role-based authorization, you can protect documents and sensitive data.

Automate your document handling and keep track of all your essential documents with minimum effort for businesses with CQ’s Document control system

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Related Checklists

Quality-centric Companies Rely on CQ QMS

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Frequently Asked Questions

  • A document management control system is compulsory under ISO 9001 and FDA. The FDA requires you to conform to 21 CFR Part 11, which enables document approval, revision, and storage along with following a defined set of procedures.

    ISO 9001:2015 also sets out some instructions for document control, including:

    • Approval for efficacy before being issued

    • Update, review, and re-approve, as needed

    • Find out changes and recent revision status

    • Availability of appropriate versions of applicable documents

    • Legible and easily identifiable documents

    • Identify the external origin of the documents and control their distribution

    • Avoid using outdated documents

    • Identify obsolete documents that are retained for a specific purpose

    ComplianceQuest’s scalable document control system is designed to align closely with ISO and the other regulatory requirements to ensure compliance. ComplianceQuest also ensures that several locations are automatically in line with data privacy and other location-specific requirements within your enterprise.

  • The document control procedure can help you to determine how documents are made obsolete, approved, updated, tracked, and published. All the document control procedures are determined by a Document Control Procedures Manual that outlines the method of:

    • Generating the document, its formatting, naming, and other technical details

    • Examining, approvals, and recording the approvals and changes

    • Recognizing when a document needs revision, beginning or requesting revisions, deciding who can implement them, and setting up the approval process.

    • Determining the parameters for publishing a document, its location, providing access based on defining who can access it, and establishing security restrictions.

    • Confirming the validity period of the document based on the date or its content and removing it after expiry is an important part of the document control procedure.

  • The document controller is responsible for assuring document control methods. Document controllers help companies comply with ISO standards and attain the corresponding certification while working for external certification bodies.

  • Maintaining document control is essential for every organization to adhere to the procedures established for that purpose. Here are five initiatives that can help to maintain document control, such as:

    • Hire the right document controllers

    • Set up proper procedures

    • Educate teams to follow the procedures

    • Choose the right software tools for document control

    • Assess the results on a periodic basis and adjust them wherever required

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