ISO 13485 section 4.2, describes the requirements which must be adhered to when producing documentation. Such documentation includes quality management manuals, procedures for approval, distribution, and change of a document and the designation of a person or persons who should implement those procedures. In the ISO13485 2016 edition, specific procedures outline the prevention on of record loss, as printed documents filed using a traditional system, are at high risk of being lost. 21 CFR Part 820, is an essential regulation not only for medical device firms but for the food and pharma industry. For both, document control is an imperative.
The ISO13485 2016 edition (sections 3.2, 3.10, 6.2, etc.) is indicating both individual and corporate how to route documents in your document management system, for example, the following routing phases: document creation(draft), approval, rejection, change control, retrieval, and obsolescence.
According to FDA statistics, document control errors are frequent and numerous. Clinical trials indicate that many documents routed and logged, are inadequately documented and contain inaccurate case histories. These deficiencies make up the second most commonly cited FDA problems, and they rank fifth by the European Medicines Agency (EMA). In warning letters and audit observations, it was discovered that inadequate documentation impacted the thoroughness and level of care physicians can offer patients. Poor document management is the direct result of paper documents, that can be easily misplaced.
In this article, I will discuss common issues which arise in every phase of the life cycle of a document. The information I will share comes out of my 25 years of experience developing ORCANOS Medical e-QMS (Electronic Quality Management System) software solutions for regulated companies, as well as my direct involvement in the implementation and deployment of ORCANOS Medical solution by quality professionals who are responsible for document control and quality management.