In medical device development, speed, efficiency, and accuracy with document control processes are a top priority. Global regulatory agencies recognize this and continue to evolve their processes and technologies to help companies achieve compliance with this aspect of quality management. A new industry brief from MasterControl addresses how regulators embrace advancing technologies to effectively achieve their mission of ensuring public health and safety — including enhancements directly related to documentation.
Traditional approaches to document control often involve resolving issues and nonconformances as they occur. New regulation trends are edging this strategy toward extinction. Regulatory entities in the United States (U.S.) and the European Union (EU) have been proactive with initiatives encouraging companies in regulated environments to adopt modernized processes and technologies for document control. Leading by example, the following are two of the FDA’s modernization programs:
After a three-year ramp-up period and a one-year postponement (courtesy of COVID-19) the European Union rolled out its medical device regulation (MDR). Medical device companies expecting to have more documentation requirements won’t be disappointed. For example, MDR compliance requires a documented risk management plan for each device.
Another document added to the MDR lineup is a summary of safety and clinical performance (SSCP). This is an annual report that manufacturers must provide throughout the device’s life cycle in order to remain compliant to sell products in the EU. This document needs to include:
Companies doing business in regulated environments are endeavoring to eliminate documentation errors and inadequacies by implementing automated document control processes. Deloitte Centre for Health Solutions reports that there has been a shift from checking that manufacturing operations are being completed correctly to a much greater scrutiny of documentation in areas such as risk assessment, change control, and deviation.4
That said, document control is the responsibility of all employees who create or use documents. Each staff member needs to understand the purpose of document control and how to follow your company's document control procedures.
FDA regulations and ISO standards for current good manufacturing practices (CGMP) require all companies manufacturing regulated products to have some type of a document control system. In its simplest form, document control refers to procedures for collaboration, distribution, approval, and change of all documentation associated with regulated products throughout their life cycle.
Because documents go through frequent revisions and approval cycles, paper documents are prone to errors, losses, and having outdated versions in circulation. Many problems go unnoticed until later in the production process. Common documentation-related observations cited in Form 483s and warning letters include:
Not long into 2020, the traditional workplace scenario began to unravel as the social distancing mandates became the norm. Because document control is not confined to a single department or role, organizations using paper-based or hybrid documents and document control systems soon discovered the limitations of those systems and processes. With an integrated document control solution, companies have the following advantages:
Digitized processes and automation give you the tools to establish a culture of quality and efficiency with documentation. View the industry brief “Automating Document Control Processes to Comply With FDA and ISO Requirements” to learn about employing more effective document control best practices.
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