26 February, 2015 David R. Butcher, Marketing Communications, MasterControl
|In FDA and ISO environments,there are multiple
reasons to consider automating SOP management.
To maximize efficiency and safety, successful companies across all industries employ effective standard operating procedures (SOPs). For companies doing business in regulatory environments, effective SOP management is imperative. An electronic SOP management system can dramatically improve SOP management in at least four key areas.
Companies across all industries use standard operating procedures to minimize potential for miscommunication and to operate safely and more efficiently. Development and usage of SOPs are a key part of any successful quality system, as they provide employees with the information necessary to perform their jobs properly while facilitating consistency in the quality of processes and products.
SOPs are integral for organizations with process-oriented operations, such as life sciences and other manufacturing companies, as a means of complying with regulations and/or quality standards. For ISO-certified manufacturing companies, properly managing SOPs is mandatory, and for companies in FDA-regulated industries, SOPs must be managed with strict change control processes to ensure proper compliance with current good clinical practices (cGCP), good manufacturing practices (cGMP) and good laboratory practices (cGLP).
As with all other business-critical information, SOPs must be managed effectively – and an effective electronic SOP management system will address a number of key challenges that regulated companies face:
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.
For FDA-regulated and ISO-certified companies, an effective SOP management system will serve as a foundation for an organization’s sustainable quality, compliance and long-term market success. An effective electronic system can dramatically reduce the time it takes to bring a new product to market by speeding up the process for document change, approval, notification and distribution. For a more comprehensive look at the benefits of an electronic SOP management system, check out MasterControl’s free white paper, SOP Management as a Compliance Tool in FDA and ISO Environments.
David Butcher has been writing about business and technology trends in the industrial B2B space for more than a decade. Currently a marketing communications specialist at MasterControl, he previously served as editor of ThomasNet News’ Industry Market Trends newsletter and blog and as assistant editor for Technology Marketing Corp.’s Customer Interaction Solutions magazine. He holds a bachelor’s degree in journalism from the State University of New York, Purchase.