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


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our reluctance to change was causing our organizations to lose massive amounts of money due to inadequacies caused by outdated processes?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

Tags: Document Control, FDA, ISO, regulatory, Regulations, automated solutions, Business Automaton

Programming a VCR Seemed Harder than Building Business Apps Today

Posted by Romeo Elias on Wed, Jul 13, 2016 @ 08:21 AM



It’s amazing how times have changed.  A couple of decades ago, that was the joke.  For those of you reading this who are too young to know or remember, a VCR, or Video Cassette Recorder, was what we had to use back then to record our favorite TV Show if we couldn’t watch it live.  This was before TIVO, Youtube or Netflix.  Viewers had to look up the schedule in a weekly publication of when their favorite shows were playing, and program the VCR to record the live TV show, so they could watch at a later time. 

The process typically required clicking a few buttons to update the date and time setting reflected on a small LCD screen on the front of the VCR.  It wasn’t too different from updating the time on a digital wrist watch.  The thing is, most people didn’t know how to do it.  It was considered very complex at the time. People would say “I can’t program my VCR” to imply they didn’t know much about technology, or some would make that statement to imply someone was not technical at all.

Skip two plus decades to today and it’s amazing how many of us are performing much more complex tasks daily on our smartphones.  Anyone today can schedule reminders on their calendars, send emails with attachments, respond to text messages with pics, perform online banking, change phone settings, download and delete apps and many more activities. User interfaces have evolved considerably over the years and they are much more intuitive.  But it is also true that people are much more comfortable with technology today, and less afraid to try new things. 

In addition, there is a shift towards doing things ourselves rather than relying on others.  Almost every service is available for us to do today on our own, without any help from experts, which many people relied on back then to program their VCRs, like tech support, banking, sharing information, publishing content, researching topics, going through airport customs, checking in for flights, and on and on.  We can even print our own products now with 3D printers. Outside of a few remaining government controlled services (printing our own passport for example) there aren’t many services that we as consumers/business users have not been empowered to perform on our own, or that there isn’t already a startup working on a way to enable us to do it.

In fact, business app development, which was once a frontier that was thought to be too complex for the average person to attempt, and reserved only for programmers, is now available for everyone.  With the advent of low-code and no-code software platforms, anyone can learn to build business and mobile apps, and many companies have purchased platforms to empower their “citizen developers,” as they are referred to today, to create business apps that automate and digitize internal processes.  Business users are now building apps to manage their business workflows, regulatory compliance processes, forms, workflows, and data.

A great question today would be, “how many of us would be able to program a VCR 20 years ago?”

If you’d like to learn more and create a Proof of Concept app with Intellect, click here for a free trial.


Tags: Workflow Managment, Business Automaton, Business Apps

Why It's Crucial that Your Business Go Paperless

Posted by Chris Fisher on Mon, Apr 11, 2016 @ 02:30 PM

Over the past few years, businesses around the world, regardless of scope and industry, have made the move to paperless, which includes documents such as contracts and invoices as well as automated business processes required for digital transactions, approvals, and eSignatures. While no business may be 100% paperless, there are many advantages to making the transition. Of course, if your business has been using and relying on hard copies of documents for several years, a change in practice will take time. To convince you of its importance, here is a look at why it is crucial that your business go paperless:

  • Focus on the Essential Tasks: Did you know that a room full of documents, complete with images, in high-resolution color, could be stored on one hard drive? For a business, this means going paperless can result in savings on storage costs as well as reduced hassle for dealing with mountains upon mountains of documents. In addition, it is frustrating to look for a single document and have to sift through dozens of files. If you move to a digital database, this will hardly take a couple of seconds. To put this simply, you can focus on the essential tasks and do away with the menial stuff by going paperless.
  • Keep Your Documents Secure: Creating a backup for documents stored digitally is convenient and hassle-free. In addition, the documents you stored online are synced on the cloud. In case of a disaster, natural or otherwise, you will still be able to access your documents, as and when required. This ensures greater security for your documents.
  • Boost Your Business’ Velocity: In today’s fast-paced business environment, you have to keep pace with the competition to not just survive, but also thrive. Going paperless and automating business processes is an effective way to boost your business’ velocity. You can speed up internal processes, improve your compliance for any audit or regulation, and streamline your dealings with your clients. Servicing clients quicker will result in more sales and repeat business.

In addition to these benefits, which affect the bottom-line, a move away from paper will benefit your business’ reputation as well. Existing and potential customers will view your business as responsible, as reducing dependence on paper means fewer trees have to be cut down, hence benefiting the environment.

So, as you can see, going paperless is the way to go, if you want to take your business to the next level. If you’d like to learn more and create a Proof of Concept app with Intellect, click here for a free trial.

Tags: Paperless Office, Business Automaton, Workflow and Business Process Management