Quality managers everywhere will attest to the fact that effective document control is critical to the quality management systems — a process that is central to any regulated organization. And depending on just how efficiently document control is done, it can either make or break the company.
That might sound a bit dramatic, but if something is not documented, what's to show that it actually happened? Every fundamental process that is published, revised, passed around, tracked, and received needs to be validated, with proof of its existence to back it up. This way, you can always make sure that they are in compliance with the regulations that your firm needs to observe.
But now, with such an immense flow of data being moved around in companies, it has become a necessity to find out newer, simpler solutions to handle documents. To help make it all a bit easier, we shall go over some ways you can improve your document control system through some of the best practices
What Is Document Control System?
Documents and records are what prove that your company is following the proper document management and manufacturing practices required for quality and regulatory compliance. A document control system is a system set in place to support this file management.
It involves everything from the organization, routing, and tracking to authorizing and distributing documentation involved in the manufacturing process. It also extends to post-market surveillance, where it helps track any documentation associated with complaints and corrective action and preventative action (CAPA), audit trails, and non-conformance reporting.
And now, we have the more efficient document control software that can support paperless process automation.
Why Have A Document Control System?
A document control system is set up to help reduce any regulatory risk that might put your company in jeopardy.
In 2020 alone, the FDA released up to 628 warning letters to firms such as drug manufacturers, life sciences companies, and medical manufacturers. But before the warning letter, the FDA usually sends a Form 483 observation. Suppose you don't respond to the warning letter. In that case, a warning letter is sent, after which you'll need to provide audit-ready documentation to prove you have the right documentation to avoid further action.
So, in short, document control is a requirement for compliance with FDA and other regulatory bodies. And having an efficient document control system can help achieve this in the most efficient way possible. Other than keeping track of important documentation, it will help streamline corrective action processes.
In addition to the FDA requirement, standards such as ISO 9001:2015, which is the international standard in place for a quality management systems, specifically requires document control for the quality management system. For this, organizations should establish documented procedures to do such things as
- Approve documents prior to the issue
- Identify changes to documents and their revision status
- Review, re-approve, and make updates to documents
- Ensure that relevant documents are readily availed at points of use
- Always make sure that documents are legible and can be readily identified
- Keep obsolete documents from unwarranted access
- Set up identification protocol on obsolete documents which are retained
Other Benefits Of A Document Control System
Better access control – With a good document control system in place, you can manage access to sensitive documents and restrict them to only the right people at a time. This comes in more so in highly regulated industries where leakages or unintended data exposure could easily lead to non-compliance, destruction of brand reputation, and a loss of competitive advantage.
Transparency of information – A DCS works to protect sensitive documents from unauthorized parties, and it should also allow for easy access to those who actually are authorized. This means they can search for, find, and retrieve both active and archived documents.
Allows for easy global collaboration – not so long ago, people solely relied on paper-based documents. To share them, you'd have to use fax machines and mails. Such techniques were painfully slow and would delay any document reviews, ultimately reducing your competitive advantage.
However, we now have cloud-based software which allows for real-time collaboration. Authorized parties can easily log in and access documents from anywhere using any device that is internet-enabled.
Can help with disaster recovery — if your institution falls prey to a disastrous event or cyberattack, you stand to lose sensitive documents. And can cost millions to recover such. It is even worse in highly regulated industries like pharma, where permanent information loss can be lethal to the survival of the organization.
The proper document control system, in this instance, would be a cloud-based system. The storage of documents off-site ensures that your data is always safe from loss.
Document Control Best Practices
1. Say goodbye to papers
Consider moving beyond the traditional means of paper documentation. It is messy, hard to keep track of, and prone to all sorts of issues. It can be to accept change and abandon old ways that have worked historically, but once you switch to a document control software, your only regret will be not doing it sooner. These systems are faster, more organized, easier to search through and allow for almost seamless collaboration.
2. Get professional input
For your new system to function smoothly, you have to get the input of process owners who've been managing the documents on a day-to-day. These are the people with the most information on how to automate the workflows and will greatly help filter the features you should set up in your particular document control system.
3. Establish clear roles
Every person working for your organization usually has their own special task to do. Well, this should apply to document control. You'll need to set up guidelines and assign the individuals responsible for each stage of the document's lifecycle.
4. Automate the processes
One of the greatest challenges to a flawless document control system is human error. And if you are dealing with huge amounts of information and documents, human error can happen quite frequently. An automated system can help manage this with fewer errors and at faster speeds. However, for this, you'll need to employ an expert to set up the proper workflows.
5. Integrate with Training
Before shifting to a new document control process, always make sure that all the team members are on the same page. Everyone should go through the appropriate training to keep up with the change. In this regard, each new employee should be taught all the processes behind document control. For best results, you can make it part of the initial training process. If any changes are made to the document control system, follow-up training should be made to make sure everyone is all caught up. The training should be recorded and integrated into the document control system.
As you've seen, there are really no limits to what you can achieve with a good document control system. We can't emphasize enough on switching to a modern, paperless and automated system for this. It can save you a ton of time and is way convenient in all the sorting, tracking, and collaboration of data. At Medpoint, we have all this in mind. We boast an experienced team of advisors, readily available to provide you all the intel you'll need to have your document control system up and running. For more information, subscribe to our blog today.