Lean Documents and Configuration Approaches in a 21 CFR Part 820 QMS
Lean Documents Approach:
Instead of creating extensive documentation within the QSDR, prioritize essential information such as product specifications, manufacturing processes, inspection criteria, and quality control procedures. Eliminate redundant data fields or sections that do not contribute directly to compliance or operational efficiency.
Design data entry forms with simplicity and usability in mind. Keep in mind these two terms are in the eye of the beholder. Therefore, form design should be a collaborative process between Quality, Document Control, the User (operator, technician), the User’s Supervisor and as many of the users/recipients of the executed form/data as possible, including System Administrators for the relevant electronic data repositories. Use standardized templates with clear instructions and prompts to guide users through the input process. Minimize the number of mandatory fields to reduce data entry errors and streamline the record creation process.
Establish a version control system for QSDR templates and forms to ensure consistency and accuracy across records. Clearly label each version and track changes to facilitate easy reference and retrieval. Regularly review and update templates based on feedback from users and changes in regulatory requirements.
Lean Configuration Approach:
Configure the QSDR database to include only the necessary fields and data structures required for compliance with regulatory standards and internal quality processes. Remove any extraneous fields that do not serve a specific purpose or add value to the record.
Design user interfaces (UI) for the QSDR database that are intuitive and user-friendly. Arrange menu options, navigation buttons, and search functionalities in a logical manner to streamline data access and retrieval. Provide customizable dashboards or homepages to allow users to personalize their workspace based on their roles and responsibilities.
Implement automated workflows within the QSDR database to facilitate seamless record management processes. Configure notifications, alerts, and approval routing mechanisms to notify relevant stakeholders of pending tasks or actions required. Automate data validation checks to ensure data integrity and accuracy throughout the record lifecycle.
These activities should be a collaborative effort that includes all the stakeholders noted previously. Too often, assumptions are made as to what is “simple” and “useable”, only to waste time and resources on changes that could have been included up front during design.