Companies in highly-regulated industries can easily fall prey to non-compliance issues without an effective information management system in place. Without a centralized and organization-wide approach for managing their content, companies leave themselves vulnerable because of the difficulty and complexity of managing critical and sensitive information and processes that affect compliance.
Given the high priority that organizations in heavily regulated industries must place on compliance management and the amount of documentation they must produce to support and fulfill compliance initiatives, it is no longer practical to manage content separately from compliance. As a result enterprise content management (ECM) must play a central integrated role in effective compliance management.
Enterprise content management solutions provide a centralized approach for tracking and storing documents and for maintaining version control. ECM also automates workflows and reminders; tracks and logs document access and versioning; integrates with other enterprise systems to eliminate information silos; and provides security by logging and limiting access to authorized individuals. In addition, ECM systems provide an audit trail of document access, versioning, and approvals that organizations need to maintain quality and prove compliance.
SOP Management: A Key Component of Compliance
An important aspect of achieving and proving compliance lies in the management and use of standard operating procedures (SOPs). SOPs document actual business operations and procedures and need to be read by employees for training and compliance purposes. With more and more employees working remotely from their mobile devices these days, the ability to leverage tablets and smartphones for reading and signing off on SOPs is critical for quickly implementing corrective actions after deviations.
The best way to document the creation, maintenance and adherence to SOPs is with an ECM system. When SOPs are created and modified, the enterprise content management solution documents the collaboration and employee access to the modified SOPs. Employees who are required to read SOPs and confirm they’ve understood the material with electronic signatures. If companies must demonstrate that their employees read SOPs at given intervals, the ECM system provides a quick and easy way for documenting and communicating it to auditors and compliance managers.
SOPs themselves can be programmed into enterprise content management systems. For example, if an SOP or regulation states that certain documents must be periodically reviewed for updates, read for training purposes or shared with other parties — that process can be managed within the ECM system, which generates automatic reminders and audit trails as required.
Conversely, a quality deviation record in the ECM system can lead to major updates of a related SOP’s and the entire workflow — from deviation recording and the SOP change request to the training of the new SOP’s to closure of the deviation — can be tracked in the same system.
There is a clear convergence between content and compliance management. Given the high demands that compliance and SOP management places on an organization, it is important to consider the benefits of efficiency, transparency, auditing, archiving, security, collaboration, process management, signature recording, reporting, and content retrieval that an ECM solution can provide.