Design History File (DHF) Remediation
FDA inspectors, ISO auditors and internal quality and regulatory personnel are scrutinizing design history files more than ever, and the consultants at Engineering & Quality Solutions, Inc. have seen this first-hand while assisting clients with QMS audits and FDA inspections. DHF deficiencies are a major source of 483 letters in the medical device industry, and we’ve helped many clients remediate their DHFs and update procedures to ensure future design control compliance.
DHF deficiencies may be related to products which have been on the market a long time and the documentation practices from many years ago just aren’t sufficient today. In new development projects some personnel or comapnies simply don’t have the expertise, capacity or procedures in place to fully comply with regulations. If a company has identified DHF deficiencies, they may be dedicating resources to remediating DHFs for existing products, reviewing current in-process development efforts more carefully, and revamping design controls procedures to make sure design files are compliant. The internal effect of the DHF remediation effort is a slowing of new development as resources attend to legacy products, improve their documentation and answer corrective actions.
It may seem somewhat painful to go through, but the ultimate effect of strong DHFs (and also the intended effect of the regulations) is a better product with fewer problems. Applying proper design controls helps ensure that the product does what is intended, is safer, is more reliable and predictable, has fewer problems, and meets market needs.
If you need expert help to get your DHFs remediated quickly and efficiently, and to free up internal resources, call us today!