Why Automation Is Essential for Document Control Compliance

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.

Regulators Drive Modernization

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:

• Technology Modernization Action Plan – Infrastructure transformation program designed to bring the agency up to speed with the latest technology and scientific advancements as well as to introduce new methods for product oversight.¹
• Electronic Submission Template And Resource (eSTAR) – PDF electronic submission template designed to “improve consistency and efficiency in how the medical device industry prepares 510(k)s and how the FDA reviews these submissions.”²

EU MDR Ramps Up Documentation Requirements

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:

• Information about the device’s safety and performance, including the clinical benefits and the success rate of achieving the intended outcomes.
• Information clarifying the residual risks and side effects with implantable devices used by the patient.
• A summary of the clinical evaluation results of all the available clinical data related to the device.

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.

Document Control CGMP

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.

• FDA Document Control Guidelines – 21 CFR 820.40 details the FDA’s guidelines for document control which cites that companies should have procedures for changes, approvals, and distribution of documentation.³
• ISO Documentation Standards – The ISO 9001:2015 standard addresses document control processes companies should have in place, including procedures for updating, archiving, and identifying documents. The standard also addresses the concept of including risk-based thinking as it directly influences the complexity of the documentation. The greater the risk of uncertainty surrounding the product, the more stringent the requirements are for the documentation and the actions the organization must take to mitigate the risk.⁴

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:

• Document errors, including missing dates or missing numbering schemes.
• Uncontrolled documents in circulation.
• Document changes without approvals, explanations, or records.
• Lack of access to critical documents.
• Missing documents.

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:

• Collaborative workspace.
• Revision control.
• Secure architecture.
• Part of single platform.

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.

References:

1. “FDA’s Technology Modernization Action Plan Accelerates the Path to Enhancing and Promoting ‘People First’ Public Health,” FDA Voices, U.S. Food and Drug Administration (FDA), Oct. 19, 2020.
2. “FDA Launches New Interactive, PDF-Based, Template to Promote Greater Efficiency and Consistency in Preparation and Review of 510(k) Medical Device Applications,” FDA In Brief, U.S. Food and Drug Administration, Feb. 26, 2020.
3. “CFR- Code of Federal Regulations Title 21 Part 820: Quality System Regulation,” U.S. Food and Drug Administration (FDA), April 1, 2020.
4. “Guidance on the Requirements for Documented Information of ISO 9001:2015,” International Organization for Standardization (ISO).