Documents form an essential part of an enterprise’s journey. Document management is also essential as part of regulatory compliance for quality and safety. From a quality control point of view, key documents include supplier-related documents, regulatory compliance documents, and documentation related to CAPA, change, complaint management, audits, and inspections.
A robust Electronic Document Management System (EDMS) is a critical element of any automated EQMS workflow. In fact, we could say it is the first step in building a quality management culture in your organization. When different teams collaborate, they need documents to keep track of progress. The management communicates to its various stakeholders in various forms and a record is essential to be maintained. Your EDMS serves as the single point of truth for all key documents.
An electronic document management system can help manage the risks and mitigate the challenges by organizing the documents in an intuitive manner for easy document management, storage, retrieval, and change.
What does an Electronic Document Management System (EDMS) mean?
Every organization will be familiar with the concept of filing documents. In an era when the paper was the primary means of communicating with stakeholders such as suppliers, customers, employees, board members, and so on, all the relevant contracts and communications would be filed in an organized manner for easy retrieval. The documents could be anything from invoices, sales orders, contracts to photographs, phone interview transcripts, and even video clips.
In this era of electronic documentation, this purpose is served by the EDM (Electronic Document Management). Computer programs and storage are used to manage the various kinds of documents an enterprise uses. You can create a new document using the EDM system or scan and store a hard copy in electronic form.
An EDMS lets you create, edit, process, revise, and store documents not just in text form but also in images, video, and audio files. Providing a single view of all the documentation, it also integrates scanning and printing features along with storage. One of the greatest benefits of having a well-designed EDMS is that it integrates with other applications such as your enterprise’s ERP and CRM, enabling you to automate document-related workflows.
Features of an EDMS
An EDMS enables document management right from the time it is created to the time it is published and even after when it needs to be destroyed as per regulatory needs. The key features of an EDMS include:
Document Creation: You can create a new document on the EDMS or input files such as scanned documents, emails, mobile applications, or the web.
Document Indexing: Searchability is one of the key features that makes it easy to locate documents. Indexing it by tagging with terms improves the quality of search results.
Document Search: The search feature should be powerful and look through the document file name, content, metadata, and have advanced filters. It should be able to find a relevant image, audio, or video file.
Document Processing: Paper-based documents need to be converted into electronic format and the EDMS should have Intelligent Character Recognition (ICR) and/or Optical Character Recognition (OCR) capabilities. It should have document templates for standard formats, link different but related documents, and integrate with the ERP/CRM system. It should enable the sharing of documents, revisions, and in-built editors for various file types.
Document Security: Your documents need to be protected from prying eyes and unauthorized access. Therefore, it should be secure, allowing access only to those who need to see them based on the role or function in the organization.
Dashboards: The reporting and analytics features of a good EDMS can help gain insights about the workflow, scheduling, access, use, and so on.
Customization: An EDMS should match the individual needs of the organization using it as not all document management needs are the same.
Additional Features: Multilingual capabilities, enabling collaboration, being future-ready, scalable, flexible, and mobile-readiness are some of the other desirable features of an EDMS.
Versioning: Documents are essential for regulatory purposes, internal and external audits as well as inspections. Therefore, EDMS should enable traceability of every change being made to the document along with capturing the person who is making the change, the change being made, and the time of the change.
What is the importance of using EDMS?
An EDMS automates your document management workflow. The four reasons why you need an EDMS in your organization include:
Improved Efficiency: However well you may file your documents, getting all your employees to follow the system when they have more pressing matters to handle can be a challenge. Not being able to locate the document you need can affect your productivity and make you lose time that can be used better in focusing on your core competency. An Electronic Document Management System enables this by keeping your documents neatly organized and easily searchable, thereby reducing the time needed to locate a document.
Reduced Costs: Manual storage of documents is an expensive affair in more ways than one. You need storage space, shelves, and time to file them in an organized fashion. With time, as the number of documents increase, the storage space requirement will also increase. Destroying obsolete documents is a task in itself, needing someone to go through them and then the waste generated needs to be managed. The paper cost is additional. Any damage to the building can destroy your documents.
An electronic system, especially on the cloud, needs less space and less cost to acquire and manage. Even in case of any calamities, your documents will be safe.
Improved Compliance: Documentation is an important part of compliance. Traceability of revisions is as crucial as creating a document and destroying after it has become obsolete. Without an electronic document management system, even digital storage in different files and folders can be a nightmare. Now, even regulatory bodies have started asking for the submission of electronic documents. With an EDMS, the whole compliance process becomes simpler. It is also easy to integrate regulatory rules into an electronic filing system rather than having to physically change all the relevant documents every time there is a change.
Legacy files also have an expiry date. Destroying files that are no longer needed is also easier. You can just schedule the date and receive an alert when it is time instead of having to keep track.
The regulator will expect you to demonstrate that sensitive information was stored correctly with all the required safety and security measures in place.
Better Protection for Your Business: Every business is constantly threatened with the risk of a data breach. Your documents contain sensitive financial, business, stakeholder-related information that needs to be protected. A document management system ensures the protection of such documents with security features such as encryption, role-based access, and so on.
CQ’s EDMS Benefits and Working
ComplianceQuest provides a cloud-based quality management system with document management as its core. The EDMS automates the documentation workflow enabling a smooth experience right from the time of creating a document to the time legacy documents becoming obsolete. The workflow is captured in its modules:
Creation and Categorization
Right from document creation to the time of its being published, the CQ EDMS makes the entire workflow smooth and easy. You can store and organize your documents in a central repository based on various templates and classification criteria. The solution provides pre-approved templates that make the creation of relevant documents in the right template easy. It also enables the linking of related documents – for quick and easy identification and cross-referencing.
Review and Approvals
Review and approvals are an essential part of the document creation process. The ComplianceQuest Electronic Document Management Solution makes it easy to assign a reviewer, alerts them when the document is ready for review, tracks any changes made to the document before it is approved. Email notifications and reminders ensure timely completion of the process. Imitating the organization’s best practices, CQ-DOC also enables approval workflows based on sequential, parallel or combination review.
Document release can be automated or done manually based on predefined ‘effective dates’. Features such as the automatic conversion of native Microsoft Office document to PDFs – restrict viewing by end-users. Employees receive notifications as needed.
Training forms an important part of the document workflow and is facilitated by the ComplianceQuest Document Management Solution. All those who need to be trained based on their job functions are alerted on a new document being issued or an existing one revised. Training Coordinators get a view of who have completed training and who still haven’t.
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.
ComplianceQuest Document Management Solutions software can help manage the processes associated with Documents Change processes such as requests, reviews, incorporation, and closure.
Who Needs EDMS? What are some sectors where a robust EDMS is a must?
Truth be told, every business across every industry regardless of its size or number of employees needs an electronic document management system. Even a start-up cannot do without an EDMS, though it may have a manageable number of documents in the early stages. As the business grows, so will the number of documents, so will its need.
The ComplianceQuest Document Management System caters to the following industry but is not limited to them:
Aerospace and Defense
Blood and Tissue
Consumer Packaged Goods
Food and Beverages
Healthcare & Life Sciences
Oil and Gas
Pharmaceutical and Biotech
- Aerospace and Defense
- Blood and Tissue
- Consumer Packaged Goods
- Food and Beverages
- General Manufacturing
- Healthcare & Life Sciences
- Medical Devices
- Oil and Gas
- Pharmaceutical and Biotech
Why is EDMS required?
An EDMS such as the one from Compliance Quest can smoothen your document workflow in many ways.
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.
Save Costs: With automation, storage, retrieval and access of documents have become simple and easy, effecting savings on costs. A Deloitte study reveals that a large retail bank was able to reduce processing costs by as much as 25% by going paperless. By storing your documents online, you can save costs on real estate and physical storage, as also ensure business continuity and disaster recovery.
Better Security : The documents need to be protected with restricted access as per your internal data governance policies. ComplianceQuest ensures that access to sensitive documents is given only with appropriate authentication and authorization.
Compliance: ISO 9001, FDA, and other regulatory bodies make document management a mandatory requirement. 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. A robust EDMS makes adherence to compliance requirements a lot smoother.
Audit Management: ComplianceQuest Document Management System also enables an audit trail by capturing details such as when a document was viewed last, by whom, and modifications made, 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 teams from across geographies and functions access the same document with greater ease. Sharing, reviewing, approvals become easier over an automated data control system, with all members getting a unified view of the documents. Traceability also lets them know any changes that were made, by whom and when.
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 business continuity is ensured as the 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.
Frequently Asked Questions
What is electronic document management?
Can EDMS be used only for electronic text files?
What features should one look for in an EDMS?
Security is another important feature to restrict access only based on permissions. Collaborations across teams based anywhere is also a key feature of a good EDMS.
Audit Trail to trace changes, by whom and when is an essential feature for both security and compliance.