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.
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.
Request an Online DemoIn 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.
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A document control system plays a significant role in a regulated environment. Its importance lies in:
#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.
#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.
#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.
#4: Better Collaboration
In highly competitive industries, paper-based approaches to document control delayed the review of documents significantly. Today, cloud-based dms 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.
#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.
#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 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.
#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.
#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.
#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.
#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.
#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.
#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.
#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 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.
#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.
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 Control 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 control 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.
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:
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 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 that assures the security of the documents, while document controlling has become comparatively easy because of document handling systems.
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 documentation. 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.
Document control system help businesses store, capture, sort, retrieve, and distribute documents. This follows a specific sequence of stages, including:
A cloud-based document control system is a boon for document controllers because of the following aspects:
A cloud-based document control system helps you easily find what you are searching for and gain access to metadata templates and revision control.
A cloud-based document control system helps you to set due dates and assign responsibilities, create project schedules, and re-use them as templates.
A document control system helps you to manage your review and approval process.
With the help of a document control system, you can use a single data source for all of your communication and assign who has access to what.
With the help of a document control system, you can use standard dashboards and reports, track milestones, and gain detailed tracking capabilities.
With the help of a document controlling system, you can manage revision handling and structure deliveries based on the right coding and numbering.
Audit-ready data can help you to control your documents and processes completely, tracking who has viewed your data.
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 quick and easy… and it’s a pleasure to use.
Choosing a cloud-based document control system will be beneficial for your organization because
There are 4 Document control practices for the implementation of processes to achieve their purpose involving:
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 refers to the duration for which a document should be retained and lined up with regulatory guidelines.
Collaborative effort is vital to understand the objectives and desired results of the document control efforts with every employee to get the desired effect.
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.
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A document 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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