According to a 2018 report by Deloitte and Forbes Insight, The Fourth Industrial Revolution Is Here – Are You Ready?, new regulations will likely be a response to how well government thinks that business leaders are managing what they call Industry 4.0. The report says that, “Definitions for Industry 4.0 abound, but the change it portends at its core is the marriage of physical and digital technologies such as analytics, artificial intelligence, cognitive technologies and the internet of things (IoT).”
Respondents to their survey of more than 1,600 C-level executives in 19 countries strongly agreed that new regulations that come into play because of rapid technological advances will have a significant impact over the next five years. In accordance with the report's prediction, recently enacted data privacy regulations like CCPA and GDPR put compliance further into the forefront of issues that are important to the business community.
Document Management and workflow automation will continue to have an important role in enabling compliance as the regulatory environment evolves. Since every industry and state has its own regulations, the effectiveness your compliance efforts lie with your ability to meet regulatory requirements with the support of a document management system.
How can document management and automation enable compliance?
In addition to ensuring that your organization passes external compliance audits for Sarbanes-Oxley, HIPAA, and other industry-specific regulations, you can save time and resources by enacting document management best practices. Document management and automated workflow enable compliance through:
- Secure storage in a central repository
- User identification and authentication
- Restricted user access when appropriate
- Assignment of roles based on user responsibilities
- Assignment of privileges, such as viewing, editing, printing and downloading, which restrict unauthorized activity
- Redaction to enable protection of personal data
- Increased ability to review and monitor user accounts
- Automatic notification when documents that are ready for review
- Notification of violations of security protocols through activity reports
- Error tracking and auditing
- Flexible tools to easily respond to information requests
- Reduced administrative costs
Replace risky manual processes with automation
When everyone and anyone can access and make edits to reports that prove compliance, the situation can easily get out of control. There’s no way to enforce security around a manual process. Many organizations still use Excel spreadsheets to store compliance-related data. Re-keying information into a spreadsheet, especially by multiple parties, is risky. Even if all participants do their best to maintain accuracy, errors are bound to occur. If you don’t catch those errors in time you can fall out of compliance.
For example, a medical device manufacturer had a manual process that involved printing out an Excel spreadsheet for a staff member who checked off each document they reviewed. Now, the organization uses an automated digital workflow that employs stamps with the date, time and name of the reviewer to verify that a document had been reviewed and approved. This electronic process eliminates errors and provides proof that the required review has been completed.
Meeting compliance concerns specific to the mobile workforce
Controlling information when dealing with a mobile workforce presents additional challenges. In one organization, home healthcare nurses traveled to patient’s homes in their own cars carrying paper-based patient records. A nurse was on her way to a patient visit and had a car accident. She took the confidential records from the car and kept them until the next day when she returned to the central office.
This is a serious HIPAA violation. In response to this incident, the organization implemented document management. Now, the nursing staff carry tablets which give them secure, permissioned access to patient records.
Best practices for enabling compliance
- Store documents with version control turned on. This allows you to see when a document was last edited and who edited it. Enable collaboration through this visibility into the editing process. A software solution like DocuWare also logs all document changes and creates a complete audit trail to manage active and past versions of documents. If users cannot track the original version all the way through to the final one, the authenticity of data is not protected, and therefore not compliant.
- Avoid confusion and unnecessary changes by limiting access to previous versions of a document.
- When you distribute a document for review, send a link to the working version, not the document itself, so you’re not dealing with different versions of the document being edited by individual team members.
- Automate retention schedules with automatic deletion or elect to send an email notification to an approver before deletion.
- Check the statute of limitations for document retention. Holding documents beyond their required retention period puts organizations at risk for security breaches and non-compliance with privacy regulations.
- Consider moving your documents to the cloud. The cloud provides built-in security. DocuWare Cloud is based on the Microsoft Azure cloud platform which leads the industry in establishing clear security and privacy requirements and then consistently meeting these requirements. Azure meets a broad set of international and industry-specific compliance standards, including as GDPR, ISO 27001, HIPAA, FedRAMP, SOC 1 and SOC 2, as well as country-specific standards, including Australia IRAP, UK G-Cloud, and Singapore MTCS.
Organizations are faced with regulations that require them to control information, retain it and make it accessible to external auditors. Digital document management ensures that business processes put in place to ensure compliance procedures are always followed and can be easily tracked and audited.
Editor's note: This post has been updated for accuracy and new content has been added.
Gain a better understanding of how you can protect your most sensitive information, ensure compliance, and implement robust disaster recovery measures to ensure total business continuity. Watch the webinar to learn more.
Joan Honig is the Content Marketing Manager at DocuWare.