By Dave Hunter, MasterControl, Product Management Director
In a regulated environment, the document control process can either be an obstacle course replete with pitfalls, or it can be a smooth ride to a successful product launch. If you want the latter, you need effective control in every phase of the life cycle of every important document.
In its simplest form, document control refers to procedures for approval, distribution, and change of a document and the designation of a person or people to implement those procedures. 21 CFR Part 820, a key regulation for medical device firms, provides a good example of the expectations of the U.S. Food and Drug Administration (FDA) and similar agencies worldwide in terms of document control.2
It is a basic requirement fulfilled by one person in some companies and a full-scale department in others, depending on the size and nature of an organization’s business. While companies vary, for most of them, document control spans the following phases: document creation, approval, change control, retrieval, and obsolescence.
In the pharmaceutical industry, inadequate documentation and inaccurate case histories constitute the second most commonly cited deficiency in FDA inspections of clinical trial sites. Similar source documentation problems ranked fifth among the top 10 findings in inspections of clinical investigator sites by European Medicines Agency (EMA). In warning letters and audit observations, inadequacy of documentation includes lack of access to critical documents by treating physicians and failure to present those documents during audits and inspections. 3 These problems are related to poor document management, especially if the process involves paper documents that can be easily misplaced.
In this white paper, we will discuss common issues in every phase of the life cycle of a document. I will offer insights based on my experience developing software solutions for regulated companies and my interactions over the past decade with quality professionals who are responsible for document control and digitization of data today, the regulation is more relevant than ever.