Most highly-regulated organisations are very familiar with audits, such as those performed for regulators and for customers who require assurance that vendors are producing products according to their specifications and compliance requirements. There are also internal audits to ensure that organisations are actually following their own quality system policies.

EIM can help streamline audits with the ability to quickly and efficiently produce evidence to verify if the right people are doing the right things at the right time across an organisation’s departments and functional groups, such as training, human resources, research and development, manufacturing, maintenance and the supply chain. With an audit trail of all designated activities, EIM also provides a clear illustration to auditors of the quality and compliance related activity within an organisation.

Furthermore, EIM provides a solution for reporting audit findings far beyond documenting them in a spreadsheet. The most advanced EIM systems can automatically establish relationships from audit findings to corrective actions and change requests. These activities are associated with responsible employees with deadlines and reminders providing better transparency and insight into the processes, as well as a clear division of tasks and responsibilities to resolve the issues found.

With limited staff and resources available for compliance-related activities, organisations need to be as efficient and cost-effective as possible in the management of this important set of processes. One of the most direct and straightforward ways to keep these activities efficient and cost-effective is with an EIM solution.

For example, an important aspect of achieving and proving compliance lies in the management and use of standard operating procedures (SOPs). The onus of managing and documenting the creation, collaboration and maintenance of SOPs is similar to that of audits, risk assessments, and change requests; however, SOPs document actual business operations and procedures, and quality standards require that relevant employees be made aware of them. The audience that reads SOPs is much larger than the audience that reads other quality and compliance content. Furthermore, if an incident such as an injury occurs, companies need to assess whether or not the employee was properly trained and SOPs were followed.

An EIM system can dramatically simplify and improve the process of documenting the creation, maintenance, and adherence to SOPs. Employees who are required to read SOPs and confirm they’ve understood the material can do so directly from the system, which then records the events, tests results, and related digital signatures. When SOPs are modified, the system documents the collaboration and details of employee access to the modified SOPs for training purposes. If companies must demonstrate that their employees read SOPs at given intervals, the EIM system provides a quick and easy way for documenting and communicating it to auditors, as well as risk and compliance managers.

In addition, SOPs themselves can be integrated into workflows. 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 itself can be automated within the EIM system, which generates automatic reminders and audit trails as required.

Change is the only constant, and an organisation can succeed in effectively managing change with efficient, transparent, and auditable processes. When an incident or deviation occurs, many organisations have SOPs in place to determine and contain the root cause, manage the corrective and preventive actions (CAPAs), issue change requests (CRs), modify SOPs, and re-train staff as needed. EIM solutions can administer these change-management processes and related content creation, modification, approval, and distribution by organising the processes and all related content and collaborators around a commonly understood “business object,” such as a CAPA or a Change Request, rather than the necessary content and related information being scattered in various silos, such as email attachments, network drives, local hard drives, mobile devices and so on.