The ISO 9001:2015 provides a set of standards to promote quality culture in organizations of all sizes. It also requires the efforts to be documented to demonstrate the effectiveness of its quality management system process right from planning, operations, and control to its implementation and continual improvement.
The ISO 9001 stresses a ‘documented quality management system’ rather than a ‘system of documents’. This nuanced difference is especially significant in that it establishes the integral nature of documentation as part of the quality process rather than as an activity that must be performed for the sake of it.
ISO specifies the core objectives of an organization’s documented information as the following:
- A tool for information sharing and communication based on the types of organization’s products and processes, the nature of the communication systems it deploys, the communication capabilities within the organization as well as the organizational culture.
- A demonstration of its plans having been implemented.
- A means of knowledge sharing
- A way to share and preserve the organization’s experiences
While the definition and basic requirements make documentation seem simple, in reality, this can translate to hundreds of documents. It is not humanly possible to create, review, approve, and maintain so many documents in paper form. Even as a digital document, they should be easy to retrieve and only the current version available to work on. From reality, we know that when multiple versions of a document are available, then the chances of error increase proportionately.
An organization can have a variety of documents and in a variety of forms. Filing and storing those, retrieving them when needed, revising and approving as well as destroying them once their validity is over are tasks that are time and space consuming and hard to keep track of. To manage and maintain the documents, a business needs a document management software. This will simplify the process as well as improve your efficiency and productivity.
What is a Document Management Software?
A software that lets you manage your documents is a document management software. Manage involves every step of the document lifecycle, right from its creation to publishing and storing, and its deletion if it has an expiry date. It allows you to scan and store the electronic version of paper documents and can also handle audio and video files. It lets all documents be tagged for easy traceability and searchability and enables the linking of related documents for cross-referencing.
It is a document repository that helps automate your document management process as well as ensures security by allowing only permission-based access.
What are the Key Features of a Document Management Software?
The enterprise-wide quality management system from ComplianceQuest has a module dedicated to documentation workflow automation through a document management system. The key features of the EDMS include:
A centralized repository to store all your documents of all types in one place based on various templates and classification types. This eliminates the need to work with outdated, paper-based documents
It enables visually tracking all the changes and revisions made to the document to speed up approvals as well as enforce review periods and obsolescence rules
You can collaborate with colleagues concurrently or sequentially, capturing changes and comments as part of the document content workflow
You can set a date and release your document automatically or manually
You can get notified when training documents are updated and track whether the employees on whom those updates are applicable have been given the required training
It integrates well with your organization’s ERP and CRM and can help with managing change requests, reviews, incorporation and closures
Being integrated with artificial intelligence, you can tag documents with metadata for superior and personalization of search results using natural language processing
It is mobile-ready, thereby being available anytime, anywhere, ensuring business continuity
Enterprise-grade security ensures access based on internal governance policies
The Need for a Document Management Software
The document lifecycle involves many steps.
The first step involves creating the document. It could be from scratch, electronically, or a paper document that needs to be scanned and uploaded. It could be a text file, an audio file or a video file. All these need to be accessible to the relevant people when they need it. Some of the documents maybe related to each other and should be classified accordingly. They need to be in a particular format as required by a regulatory body or as per internal policy. They need to be tagged with metadata for easy searchability.
Then the document needs to be reviewed, revised and approved, the changes are made trackable by all concerned, and once approved, it needs to be published and stored. With time, storage space can become a challenge if you are managing paper documents. Even electronically, you will need to keep increase your storage capacity as the volume of documents increases.
Some documents need to be stored up to a particular time and then destroyed. You will need to keep track of that. The security of the documents is essential as they contain sensitive information that need protection. There could be a need for training based on document updates which also needs to be enforced and tracked.
The document lifecycle has several processes involved and it can be time-consuming for your resources to just follow up on actions. A document management software automates all the processes, improving your productivity.
Some of the advantages of a document management software such as the one from ComplianceQuest include:
Automate Document Lifecycle: Document workflow automation is one of the greatest advantages of an EDMS that lets you set alerts and improve searchability, traceability, etc.
Reduced Storage Space: Being a cloud-based solution that is scalable, robust and secure, the CQ EDMS can reduce your infrastructure costs and as you pay only as per the space you require.
Greater Security: The CQ solution ensures that your sensitive documents are protected and access based on your internal governance rules. You also get an audit trail, informing you of who viewed the document last, when and whether it was modified, what was the modification etc., making the changes traceable. You can also set alerts every time a change is made for additional security.
Improved Regulatory Compliance: Be it the ISO, FDA, HIPAA, GMP or GDPR, you can experience improved compliance with the CQ solution. You get pre-formatted templates to make your document creation process simpler and conform to the regulatory requirements. You can automate retention schedules and classify and store them better.
Easier Access: With classification, tagging and metadata, searching and retrieving documents is faster and you can also have access to related documents.
Better Collaboration: You can share information and collaborate much better with a DMS as being cloud-based, documents can be viewed from any location. Track changes and audit trail improves version control, ensuring all are literally on the same page.
Better Business Continuity: Cloud-based solutions provide an assurance of business continuity and disaster recovery with ease. Also, even your mobile executives can access the documents from anywhere if they have the authorization to.
A good document management system that promotes a quality culture aids in an improved customer relationship, competitiveness and flexibility. It improves supplier management as well as helps you get a better hold on product quality.
CQ’s Document Management Software Benefits and Processes
The CQ Document Management Software, being a part of its enterprise-wide quality management system, empowers you to automate and manage your entire document lifecycle. It provides you with complete visibility throughout the document lifecycle and improve your decision making by providing a single source of truth across all locations.
Regulatory bodies are becoming more stringent about compliance and nonconformance can attract penalties that not only cost money but also the reputation of the enterprise. Having a cloud-based document management software that provides a holistic view and enables version control improves collaboration with less confusion and reduces the chances of errors.
The cloud-based system also is scalable and provides a central repository to create, modify, review, approve, store, organize, access and share documents globally in a controlled manner. Tracking each document from the time of its origin to obsolescence is made easier with audit trails, alerts and notifications.
The CQ DMS also enables analytics and provides graphical dashboards, integrated collaboration and workflow tools.
Automate Documentation Workflow: Be it creating new documents, reviewing, publishing, or classifying and storing them in a central repository, ComplianceQuestions Document Management automates the entire document workflow. You can automate your approvals, reviews, and change management processes, thereby ensuring a single version of the truth that can be easily identified and cross-referenced.
Boost Productivity and Efficiency: CQ EDMS facilitates a workflow-driven process aided by secure digital capabilities. It simplifies creating and updating documents with the right templates available in the system. The process of document review/approval is streamlined ensuring consistency and timeliness. There is an improvement in operational efficiency as the correct and current version of the document such as SOPs, policies, plans, work instructions, or manufacturing and production designs, can be traced easily and more cost-effectively quickly. It lowers the risk of document loss and mismanagement.
Ensure Audit, Regulatory and Organizational Compliance: Regulatory compliance has become essential across industries and document management is an integral part of conformance. CQ DMS enables you to transform your document management process such that it satisfies quality and regulatory compliance from ISO9001 to GxP standards. Not only does it facilitate automating the document workflow, but also integrates with other quality processes essential for regulatory compliance such as registration and surveillance audits, CAPA escalations, non-conformance, change control and customer complaints. You can be anytime ‘audit ready’ due to the traceability and searchability features. Further, the software also ensures compliance to information security and regulatory guidelines such as multi-password access and digital signature, forced expiration of passwords, account and intruder lockout, and audit trail history/record archiving.
Improve Collaboration: One of the common challenges enterprises face is the siloed approach to documents that makes tracking and tracing very difficult. And many enterprises also face the challenge of having legacy paper documents. You can eliminate all such silos with a single enterprise-wide system such as the document management software from CQ. The robust, cloud-based platform enables organizing all your documents in one place, facilitates information sharing as well as smoothly creating, reviewing and updating documents. Role-based permissions ensure access with security, visibility to changes in real-time and responding instantly with sign offs and approvals. You can also collaborate across your supply chain by including suppliers and contract manufacturers to get their input and keep them in the loop.
Up-to-Date Training of Employees: Your employees need to be up to date with the current policies and SOPs and have easy access to relevant documents and workflows. CQ’s Training functionality ensures that employees are notified when CAPA-driven processes or work instructions change and effortlessly track that all appropriate reviews have occurred. Responding to audits with detailed data on who has been trained on new/updated documents is also made easy.
Implement Best Practices: Running operations consistently across existing and newly built or acquired facilities on a global scale requires a common set of processes. With a cloud-based document control system, all your facilities always have access to the most recent set of approved procedures. Best practices are easily shared and standardized across the organization and new operations are consistently onboarded.
Support Your Entire Organization: With the ComplianceQuest solution, all relevant people have access to the document workflow. These include:
- Document Creators (Owners)
- Document Coordinators,
- HR and Training Managers
- Quality/EHS/ QHSE Managers
- Production/ Supply Chain/ Operations Teams
Relevant Across Industries: The CQ document management software is relevant to businesses of any size and across the industries including but not restricted to:
- Aerospace and Defense
- Blood and Tissue
- Consumer Packaged Goods
- Food and Beverages
- General Manufacturing
- Healthcare & Life Sciences
- Hi Tech
- Medical Devices
- Oil and Gas
- Pharmaceutical and Biotech