Don’t Choose a Document Management System Unless It Has These 11 Qualities
Heavily regulated manufacturers that are still using informal documentation practices have found it difficult to keep pace with the ever-shifting compliance requirements. Unfortunately, the needs of the FDA and forthcoming EU MDR/IVDR in 2020 require a controlled document management system.
Moving from disjointed, paper-based methods to an electronic document management strategy may seem overwhelming.
Nevertheless, the correct approach, as well as the right technology, will better support innovation and agility. It is of the utmost importance to preserve the validity of the product data throughout the manufacturing processes.
An automated document management system allows you to create, organize, store, access, revise, and track information in electronic format.
In addition, it can connect to other quality and regulatory systems to increase the efficiency of information search and retrieval.
Furthermore, poor document management could extend or halt production, cause the manufacturing of faulty products, lead to sanctions or even worse endanger the customers.
Here are 11 qualities your organization should look for when considering an upgrade or moving to an automated document management system:
1. Accessibility
A well-designed document management system can minimize the risk of dissemination mishaps by having controls in place that maintain the integrity of the document management process, yet also allows it to be accessible by authorized users.
A robust document management software provides collaboration tools to let you create, modify, review, and distribute documents in a controlled manner — all from a secure central repository which maintains all documents, revisions, and record a complete document history throughout the product lifecycle.
2. Centralization
Whether sifting through paperwork or trying to locate an electronic document on a desktop, tasks eat away at an organization’s person-hours and can even create the need to duplicate or recreate the document in question.
With an automated document management solution, the storage and management of documents across the enterprise and throughout the document’s lifespan can be preserved all from a secure central repository.
3. Revision Control
With so many employees being involved in the creation and modification of documents, a document management system uses revision control to ensure the document being modified is the current version.
Every revision, including redlining, collaborative edits and approvals can be easily processed and tracked back to the individual.
4. Permission Controls
With so many phases within a document-cycle, it’s imperative to maintain a separation from who and when someone can access a document.
For instance, the same employee who was involved directly in documenting a manufacturing process. May not be the same person who validates and approves it.
Functionally, a modern document management software solution allows you to control access with configurable permissions, security settings, and secure check-in/check-out for authorized users. A permission-based system help ensure document integrity.
Furthermore, the system should have the capability to alert appropriate staff of new or revised documents as they are released. And if desired, records their acknowledgement.
5. Routing and Escalation
As previously mentioned, a document can change many hands throughout the lifespan of a product with each employee contributing something to the record. In some case, documents could fall behind completion deadlines.
With a paper-based or non-siloed process, finding the current document owner is a time-wasting effort. However, an automated document management system can notify supervisors of late or incomplete tasks. As well as relevant personnel is automatically notified when a document is updated.
6. Competitive Advantage
An automated document management system can also provide a competitive advantage as it allows for errors to be mitigated faster, which increases the flow of operational processes.
Having documents and data flow smoothly and accurately allows business decisions to be made faster. Even with the superabundant amount of data ̶ structured or unstructured, an automated document management system creates information synergy when properly implemented.
7. Reduce Costs Through Automation
Paper costs cents on the dollar and with the amount needed for a “paper-trail” or “chain of evidence” for audit processes which can consist of thousands of pages; the costs add up. More importantly, when the “chain of evidence” is broken, due to missing pages or a missing step in the process. The cost of noncompliance increases tremendously.
According to the FDA, 78 warning letters have been already issued in the last 90 days for poor data management.
An automated document management system is required for satisfying audit requirements and its environmental friendliness can significantly improve enterprise “greening.”
8. Security
Logically, it takes a lot more work to hack a prepared system then it does to break into a file cabinet. Where a well-implemented document management and control system provides the security for your documents in one centralized location where only those with the authorization to access can get easily to them.
9. Audit Readiness
No one wants to go on a scavenger hunt when the auditor arrives. An automated document management solution provides inspectors with up-to-date documents, fully visible audit trails, time-stamps, and electronic signature compliance.
10. Streamline the Change Control and Review Process
A powerful automated document control system can provide your organization with flexible routing options, controlling access and information as well as enables your business to get the process to the next phase smoothly.
Delegation and escalation rules could automatically keep the ball rolling where your organization doesn’t miss a due date due to an employee being sick that day.
In addition, a complete system will maintain the original document throughout the process and record revisions along the way; making it possible to rollback changes and know who’s made what change when.
11. Integration
A system where documents are in paper-form or must be copied over into another system lacks control.
A document control system that allows for integration with your other solutions such as ERP, Quality Management System (QMS), Evidence Management, email client, CRM software and other management software solutions; provides your organization with more control and aids in maintaining the integrity of the document trail as well as streamline the workflow process.
Conclusion
If your business is currently using paper-based processes or saving electronic documents in different systems across your enterprise. Consider how often that information is misplaced, duplicated, damaged, or incorrect, due to overlap, accidents, or a break in the chain of custody.
When evaluating document management solutions, make sure the solution allows you to easily configure it to conform to your organization’s industry and regulatory standards (e.g. FDA, NERC, EMEA, etc.). Having a dynamic document management system in place that adheres to industry regulations and is flexible to meet changing compliance standards is imperative.
Lastly, when purchasing a document management solution for your organization, it is good to keep in mind how your staff will respond to recent technology. Find a vendor that also provides training and ongoing support for their product. This will help your organization get ahead of any potential pushback and better streamline the implementation process from inside out.
