Benefits of an Automated Digitized Solution for Document Control to Help Meet ISO and FDA Regulations

Posted by Romeo Elias on Mon, Feb 12, 2018 @ 11:56 AM

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Why do people cringe at the very thought of compliance and change? Perhaps it’s because compliance means having to behave according to someone else’s command, and it’s our natural reflex to be resistant to being controlled, and skeptical of change.

But what if our reluctance to change was causing our organizations to lose massive amounts of money due to inadequacies caused by outdated processes?

The loss of revenue that occurs when document control systems are inefficient can be significant, and can cost manufacturers millions of dollars. These inefficiencies can be traced to the use of paper/hybrid-electronic systems which partially involve a manual approach or the combination of both digital and paper files. As with any manual approach, this was prone to error which resulted in delays.

And for this reason, FDA-regulated and ISO-certified companies mandated with a document change control system have shifted to automated digitized solutions which eliminate the laborious and time-consuming manual management of documents.

Here are the main benefits of an automated digitized solution for document control and how it helps ensure companies meet ISO and FDA regulations:

Easy Creation of Various Types of Documents

An automated digitized solution simplifies document creation. Different document types mean handling each document differently and may consist of separate approvers and workflows. An automated solution simplifies the creation and approval of documents, assigning the correct workflow based on each document's unique routing.

Faster Review and Approval

It’s up to the system to route documents to be reviewed by the relevant employees, ensuring final approval is received on all documents before they are used and distributed. Automated digitized solutions

have intelligent business rules that make room for deviations in the process when necessary.

Employee Training Integration

When the Training Management system is integrated with a document control system, companies can easily define which employee needs training on each document. The systems updates training records, allows self-training, and automatically updates employee status when training has been completed.

Promotes Collaboration Through Visible Reporting

When the reporting system is integrated with good document control, employees can quickly and effectively look at data to run the necessary reports. Visibility allows employees to look at data and keep business processes consistent and controlled.

Keep Data Secure Through Intuitive Filtering

A centralized system doesn’t mean that all users should be granted access. For security reasons, employees should only have the appropriate access to documents needed for them to approve, review, and make any necessary changes. A document control system allows you to filter and secure data thus limiting visibility data to only what is relevant to each user.

In conclusion, document control systems are put in place to ensure manufacturers are building products that are reliable and safe. ISO and FDA regulations are enforced to ensure that both process and documentation follow pre-approved methods.

For a company to thrive, it needs to recognize that compliance is a necessary tool that will give it a competitive edge. Achieving and maintaining compliance ultimately leads to efficiency and better output. Having an automated digitized solution helps you achieve all that by eliminating manual processes that are prone to error, giving your ability to filter access, automate redundant processes, and ensuring the correct routing and workflows.