Regulated Industries

FDA & GxP SOP Learning Management Solutions

Regulated industries

In fields as varied as manufacturing, government, law enforcement, health care and many more, one thing is consistent: the need for rigorous employee training to meet exacting regulatory standards for quality and safety. The SyberWorks Learning Management System (LMS) for regulated industries makes it easier to keep training resources and standard operating procedures up to date, resulting in a streamlined certification process and a more capable staff.

SOP challenges

For any workplace, but especially in highly regulated industries such as manufacturing, health care and government, documenting and maintaining standard operating procedures for every job role and function is a crucial task. But managing SOP documentation to ensure product quality and employee safety is easier said than done, even in small organizations. Without an intuitive document management system to manage SOPs, organizations invite numerous challenges:

  • Simply updating all SOPs with new information becomes a constant challenge.
  • Procedures for maintaining SOPs and the documented processes for every role in the organization can all get disorganized through attrition or employee vacation time.
  • Training new employees or conducting continuing training for certification or career development becomes a struggle.
  • When new versions of SOPs are created, notifying all relevant employees that they need to read and sign the new version and then tracking compliance can be an administrative nightmare.

ISO 9000, the standard quality management system across numerous industries, requires ample controls in place to keep SOPs organized and workers at peak performance in all conditions. Organizations often build upon ISO 9000 standards to develop a comprehensive quality management system specific to their needs.

In accordance with ISO 9000 and industry standards, an organization’s quality management system should take a four-tiered approach:

  1. Quality manual: A series of policy statements in compliance with each element of the ISO 9000 standard.
  2. Procedures: Defining the policy in terms of who is responsible for carrying it out, as well as the applicable hierarchy of management authority.
  3. Instructions: Specific details on how to perform each task.
  4. Records: A process for creating standardized documentation, notifying employees of new versions and reporting of results to ensure compliance with all of the above.

Finding a better solution

Without a comprehensive solution to facilitate the creation and management of SOPs for regulated industries, companies invite myriad errors, quality issues and safety risks. The SyberWorks learning management system (LMS) and document management system (DMS) each provide highly regulated organizations with the tools needed to make SOP creation and implementation easy.

The SyberWorks LMS/DMS fully supports the requirements of Title 21 of the Code of Federal Regulations as overseen by the Food and Drug Administration, making it ideal for those in manufacturing, pharmaceuticals, government and other related industries. This is aided through useful features such as:

  • Version control on SOP documents, with time stamps and electronic signatures.
  • Audit-ready records of all changes and actions pertaining to documentation, creating a digital paper trail.
  • Automatic data backup.
  • Advanced security features like password authentication, system validation and time-out enforcement.

When SOP control and learning management are made more intuitive, everyone involved in the process benefits:

  • Labor costs are reduced as quality management and training becomes streamlined.
  • Organizations can be always ready for otherwise costly surprise FDA audits.
  • Managers and executives can more readily track employee progress, leverage process improvement through training and ultimately increase productivity.

For more information about the SyberWorks FDA GxP SOP LMS/DMS Solution, email us at info@syberworks.com or call 888-642-7078.