Automated SOPs and a Training Management System: The Yin and Yang of Quality Management

Together - SOPs and Training Management

Generally, one plus one equals two, but from our experience with our customers, sometimes it can add up to a lot more.

Investing in an automated system for managing Standard Operating Procedures (SOPs) is often one of the first steps growing pharma companies make as they start to build an electronic Quality Management System. That makes sense because it is (on the one hand) a relatively straightforward project and (on the other) a critical element in ensuring compliance with regulatory requirements.

Investing in a training management system often comes later to ensure every team member has completed every training activity for their role. Managing SOPs and managing training each delivers significant impact. The combination of the two delivers benefits beyond each system independently.

According to the dictionary, the Yin and Yang of Asian philosophy are complementary forces that form a harmonious whole together. That is a good way to think of automated systems for managing SOPs and Training. Two critical systems that, when combined, deliver a whole, end-to-end, integrated system.

SOPs as the Foundation of the Integrated System

Managing SOPs ensures that every step in the manufacturing (or any other) process is defined and documented. And because SOPs must be constantly updated to reflect changes in procedures, the change management process must be meticulously followed.

At any time, there may be an SOP in effect, another in development, and yet another in the approval process. And, of course, retired SOPs must also be carefully managed because it is imperative to know what SOP was in effect at which time.

Managing the multiple versions of SOPs and ensuring there is only one in effect at any time is a surprisingly challenging task with an automated system. Equally challenging can be the creation, editing, and approval process for creating new SOPs or updating existing SOPs.

Typically, SOPs have multiple authors, editors, and approvers, so keeping things organized can be challenging. The approval process, especially, can be cumbersome, often including multiple approvers and the requirement for signatures by each.

A Document Management System makes all these SOP-related tasks much easier by keeping track of the state of every version of an SOP, tracking edits and changes during the drafting process, routing new SOPs automatically through the approval process, and collecting authorized signatures in the process.

So, acting alone, a Document Management System that provides these capabilities delivers big benefits in compliance and time saved. But the biggest benefits come when that system is combined with a Training Management System (TMS).

A Training Management System Multiplies the Benefits

Training Management Systems (TMS) track every team member’s training plan and completed training activities. These are typical areas of focus during audits and typically an area of last-minute scurrying before audits. If you are responsible for quality in your organization, you have certainly dealt with trying to complete training activities by delinquent employees in the days – sometimes minutes – before an audit.

A TMS makes the whole process easier by providing, at any time, a report of completed training activities versus overdue training activities, all based on standard training plans associated with each role. That means driving compliance is easier and can be done continuously, avoiding that last-minute rush to complete training activities.

A TMS will also deliver training materials right to a staff member’s inbox and provide reminders and notification of new training requirements. So, like a Document Management System for SOPs, a TMS plays a very valuable role in ensuring compliance with quality standards and regulatory compliance.

SOP + TMS: Better Together

Each system plays an important function in quality management, but they become much more powerful together. And that makes sense if you think about it because what is most training about? An SOP, of course.

In fact, many “training activities” are simply reading an SOP and then signing off that you have “Read and Understood” it. So, the relationship between a TMS and a system that manages SOPs is truly Yin and Yang – two independent but complementary systems that create a unified whole.

Working together, every time a new or updated SOP is approved, the need for it to be added to the training plan of each relevant employee is automated. The new SOP can then be distributed to each appropriate person, signed “read and understood” statements collected, and training records updated.

Most training systems, including ours at Scigeniq, include the ability to require the completion of a test or quiz as part of each training task to signify understanding on the part of the trainee.

The two systems together create a complete, closed loop, which is always the goal of every quality system. And the benefits of the two systems multiply. Implemented and integrated together, more time is saved, fewer human actions are required, and compliance with quality and regulatory requirements is increased dramatically.

The Proof is in Our Customers

Among our customers at Scigeniq, we have seen how each system works independently and how the benefits of the two systems are compounded when the second system comes online. We are increasingly urging our customers to implement both simultaneously to garner those benefits more quickly and accelerate the return on their investment.

It is clear to us that the incremental benefit is worth it. Because Yin is good and Yang is nice, but Yin and Yang together take things to another level.

Ready to learn more? Request a demo to see these two solutions in action together.