Do you know where every single “controlled” document is and who has access to that data?
With companies adopting new digital technologies while grappling with evolving regulations, knowing where your documents are and who has access can be a major headache and source of compliance issues.
Document control is a critical part of your business. However, it is easily overlooked.
You likely have dozens of tasks and responsibilities competing for your attention every single day. Keeping documents organized, controlling who has access and systematically managing versions is probably at the bottom of your to-do list.
Unfortunately, neglecting document control opens you up to serious risks. The consequences of not adhering to regulatory policies and "controlling" your documents can be dire from lost team productivity and regulatory compliance risks to large data and security breaches. In this post, we’ll explore each of these three document control risks in more detail.
Risk #1: Lost Employee and Team Productivity
According to the International Data Corporation, knowledge workers spend an average of 2.5 hours per day just searching for information.
When you are spending time navigating multiple systems with clunky search and outdated user experience interfaces looking for specific documents, you are adding unnecessary complexity to tasks, decreasing transparency across departments, and increasing the likelihood that your employees will take shortcuts and not follow SOPs leaving your company at risk.
This becomes a bigger issue when a key employee leaves the company. It makes it that much harder to find the right version of the document you're looking for because there's no "single source of truth."
A modern document control system - like Veeva’s Document Control Solutions - allows you to work faster, ensure that only the right people have access to the proper documents at the right time, and work in a system that is as easy to use as Google or Amazon while staying compliant.
Risk #2: Regulatory Compliance Risks
Did you know the FDA sent out 436 warning letters in 2017? If you are in a highly regulated industry, you need to be prepared for an audit at any time.
Most companies are using a mashup of outdated and disconnected systems and processes to "control" documents like spreadsheet trackers, desktops folders and shared drives. If the FDA is requesting specific audit-documentation, it could take you days - if not weeks- to find what you are looking for. You might not even be confident that you have the latest stamped version. And, the worst time to find out that you have the wrong version of a controlled document is after you send it to an auditor.
A document control system - like our solution - can make it easier to alert stakeholders to issues, provide faster audit documentation and fix any issues that may arise. It also provides necessary audit trails to capture every event in a process, including 21 CFR Part 11 compliant signature execution, task creation and assignment, and more.
Risk #3: Data Breaches
Almost 50% of all data breaches are caused by hackers or criminals. On average, they get access to 24,615 records in a single breach.
The average cost of a data breach is $3.86 Million. That number is even higher in the U.S. at $7.91 Million.
When you are using different systems and processes, the chances of not having proper security protocols in place, having unsecured data across different devices, or even losing a device - such as a smartphone- with data on it go way up. This increases your chances of a major data breach.
The impact of data breach go far beyond some site downtime but can lead to a decrease in sales, company data loss, compromised customer and employee data, putting your intellectual property at risk, compliance issues and an increased likelihood of future security issues and breaches.
While these three risks are common across regulated industries, they don’t have to stand in the way of bringing better products to market faster. Take this 60-second quiz to gauge your risk level for document management compliance issues.