How to improve efficiency with a Document Management System?

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Article Context:
  1. Why Document Management?

Companies look forward to increasing their productivity, accomplishing goals, and earning profits. To achieve it, handling business documents and files plays a critical role. When done right with streamlining the process and improving the efficiency of documents, it will enhance success possibilities as improper handling of documents and files leads to loss of critical company information and process deviations.

Documents talk about the organization’s procedures, policies, and processes. But, again, consolidating the paper documents, publishing, reviewing them, tracking their progress, validations, and proving their existences and retrieval when required for inspections is not easy. Moreover, complying with regulations handling paper documents is a hectic job.

 

Why is Document Management essential?

The FDA (Food and Drug Administration) sends out a Form 483 observation letter seeking evidence of quality processes handled by the organization. If not responded, a Warning Letter is issued, expecting audit-ready documentation proving the quality process.

Note: Form 483 Observation – an inspectional observation highlighting the regulatory violations related to process, equipment, procedure, controls, facility, etc. found during an inspection in an organization

With methods like change control, manufacturing procedures, medical device designing processes flowing in the life sciences industries, an efficient document handling process is necessary to manage documents effectively.

A Document Management System sets the company’s systematic process to support and streamline documents/files management, ensuring quality procedures and practices to help reduce regulatory risks.

DMS Software enables organizations to effectively manage quality documents like SOP’s, change controls, work instructions, manufacturing procedures, audit records, etc. It makes the document handling process easy with configurable metadata fields for generating a document and workflow states to process the document flow required by the organization.

So, let us discuss how to improve document handling efficiency with a Document Management System (DMS).

Configurable and Automated Workflows

Distributing and keeping track of documents is the most time-consuming process and is prone to human error and loss of information when not streamlined and appropriately managed, slowing the strategy and growth. The key to addressing this in document management is automation. DMS allows easy creation of documents and tracks the out-of-document changes with timestamps in audit trails, and the content/ information edits are tracked in version logs by check-out and check-in features. Document Management System allows the users to access the documents whenever required and provides access to those who need them based on the RBAC (Role-Based Access Controls). This way, DMS streamlines and automates the document activity from one workflow state to another with validation checks notifying the users of their actions from creation to storage and distribution across the organization.

Segregation and Searching of Documents

Searching the paper-based documents in cabinets or scrolling through emails and desktop folders is a hassle, time-consuming, and can lead to unintended data exposure. The documents created are contexted automatically with identification numbers and configurable metadata fields for easy and advanced document search. DMS leveraging advanced filters and search options, documents are found with just a click.

Segregation of data is key to organizing the documents better that helps users with easy accessibility. In addition, it helps the organization to oversee its documents irrespective of their type on a single platform. Leveraging a potential document management system in the company is to limit the access of confidential documents and give access to those who can make informed decisions and resolve the company’s bottom line issues.

Easy Retrievals and Inspections

The search filters and documents sorting in specific variables make it easy to retrieve documents faster in DMS. In addition, the copy edits with timestamps and E-signatures of approvers who authorized the policies and procedures and those who did not agree to the company’s policies and their comments are captured and maintained in a non-editable audit log, making it accessible during inspections. Furthermore, the version history captures and stores the latest version of the current document while documenting the older versions with downloadable content for reference in PDF or source format.

Better Collaboration

Teamwork in the workplace maximizes success as it enables employees to work in coordination and share knowledge. However, when the business strategies, policies, and procedures spread across teams and multiple locations, collaboration can be complex when businesses rely on emails for distribution, reviewal, and approval of policies/procedures/documents. Hence integrating an intelligent document management system makes it easier for the organization to distribute and share documents to multiple recipients for feedback and input as it allows real-time collaboration. In addition, it enables the authorized access and approval of documents at any time.

Access Management 

Security is a critical aspect of DMS, which resolves the need for digital protection of documents. It is about the authentication of the user’s login, restricted access, and e-signatures with passwords. With DMS, the organization has the power to grant access, read, write, and approve rights of the documents to users. In addition, the organization can decide who should have access to which document and to what level and how much access they should have. Also, the document owner has the privilege to monitor and track the changes of the author of the document having access.

Further, DMS being cloud-based ensures easy retrieval and backups of data. Unlike paper-based, flood, fire, and short circuits cannot destroy the documents. With redundant servers in place, there is no loss of information.

Conclusion – How DMS can improve compliance?

A DMS is vital for the life sciences industry to comply with the regulatory body. However, the compliance requirements of life sciences documents like policies, SOP’s, device designs, manufacturing procedures vary with document type and can be complex. Therefore, non-compliance with such documents results in legal issues and warning letters.

To conclude, implementing an intelligent document management system like DMS to manage and streamline business documents workflows saves resources, time, and money in compliance with the standard regulations.

Key benefits of DMS for an organization’s compliance:

  • Stores documents on the cloud with facilitated information backup and an easy retrieval process.
  • Role-Based Access Control (RBAC) ensures who should have access to the documents to what level and to what extent.
  • Non-editable Audit trails – Compliant with 21 CFR (Code of Federal Regulations) Part 11 captures micro edits of those who, when, how long they view the documents and what changes they have made with time stamps.
  • Automates workflow with validation checks of filling up the mandatory information.
  • Notify the users of required approvals of documents so that they are up to date with the information on documents.
  • Version history keeps track of all versions of a document while maintaining the information of each version of the document.
  • Secures E-Signatures of users who read, reviewed, approved/rejected the document/policy/process/procedure with comments.

Implementing a suitable DMS will make compliance an integral part of the organization’s day-to-day operations. In addition, it can save time by enabling real-time distributing, tracking, and collaboration of data.

To know more about how your organization could benefit from DMS, schedule a one-on-one call with our team by writing to us at sales@complinaceg.com.

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FAQ's

What is electronic document management system?

An EDMS-Electronic Document Management System is a system that allows creating, classifying, organizing, manage and controlling documents and records from the creation till their disposal electronically.

What features should one look for in an EDMS?

Document Management System (DMS) allows for creating process-related and procedural documents in several formats, editing, managing, retrieving, storing documents electronically, providing a single view of documentation in a platform that is easy to collaborate and use. It is a platform that enables the creation of documentation till its disposal as per the regulatory standards. The key features include

  • Easy creation of documents in several formats
  • Automatic document indexing
  • Filters and Search
  • Document processing
  • Cloud storage
  • Dashboards
  • Version Control
  • Download and Print
  • Audit trails
  • Archive

What are the benefits of an EDMS?

Paperless documentation and compliance are the most significant benefits of having an eDMS. Automated workflows make the creation, organizing, classification, and approval easy. In addition, the approvals and rejections of documents are authorized with e-signatures. Enhanced security with role-based access, providing a complete audit trail with time stamps and user information.

Why is it important to maintain documentation?

Documentation plays a crucial role in the life sciences industry. Proper documentation proves that the processes and procedures are followed to comply with regulations. In addition, it helps to discover the patterns that can uncover the issues and track progress in resolving the problems documenting the corrective and preventive actions.

In an organization, documentation minimizes risk, as it is an excellent tool in protecting against complaints and regulatory issues. In addition, documentation helps ensure approvals and rejections. Finally, proper documentation helps maintain compliance regarding legal and regulatory requirements.