Why Automation Is Essential for Document Control Compliance

Regulators Drive Modernization

  • 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

  • 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.

Document Control CGMP

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

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