|In FDA and ISO environments,there are multiple
reasons to consider automating SOP management.
This article is related to the Whitepaper:
SOP Management as a Compliance Tool in FDA and ISO Environments
To get the full details, please download your free copy.
1) Document Accessibility – In paper-based systems, where employees check out documents manually, the process of routing, reviewing, changing and approving an SOP can be slow and inefficient. Tracking down document activity can be difficult: When being routed, an SOP may get lost on a colleague’s messy desk, meaning that search and retrieval of the SOP would entail sorting through piles of paperwork.
With an effective electronic system, the review process can be carried out more efficiently than a paper-based system by using recipient routing functions. An electronic system automates SOP routing, delivery and storage, significantly increasing the efficiency and effectiveness of SOP management while providing a secure, centralized repository that makes search and retrieval easy by tracking every document’s exact location. SOPs will not get lost because the system can track every document’s exact location.
2) Revision Control – In a paper-based system, where reviewing or making changes to SOPs often requires manually submitting change requests in face-to-face meetings, the process of updating SOPs takes a lot of time and effort. Another common challenge is that employees may use an obsolete or uncontrolled SOP that is too easily accessible in a binder on a nearby desk.
An effective electronic system makes it easier to maintain an SOP’s accuracy by enabling document revisions to be made by authorized users in one place, and by providing a time-stamped audit trail that captures details of the revision. Changes are initiated and approved electronically, then tracked and made available through reports. The original version is automatically archived upon approval and release of the revision to ensure that only the current, approved version of an SOP is available.
3) Employee Communication – In a paper-based system, where quality processes often aren’t connected, communication between people who operate those processes often breaks down, leading to delays and poor results. And in fast-paced organizations, where SOPs are likely to change frequently, employees affected by the changes may not be notified in a timely manner.
An effective electronic system enables automatic follow-up – sending notifications until the person acts on an SOP – and incorporates escalation – so if the authorized approver is unavailable for a period, the SOP will move to the next authorized approver. Web-based platforms allow off-site or traveling employees to participate in the review and approval process online; and even third parties such as suppliers and consultants can have limited access to the system so they can be immediately notified upon approval of changes to SOPs that affect them.
4) Employee Training – In a paper-based system that is disconnected from a training control process, training requirements aren’t always updated with the latest approved and released document revisions in a timely manner. This means that employees often fail to keep up with appropriate training on new SOPs, so even if employees are using new SOPs, they may be using them poorly.
By integrating training control with SOP management, organizations are able to automate assignment, monitoring and verification of training tasks, as well as exam grading. Employees affected by new or revised SOPs are sent training tasks automatically, ensuring up-to-date training requirements are met. Another benefit of an electronic system is the ability to implement a progressive training program by sequencing training courses.