Title: Non-Compliance with Document Control
Course: PW-Course-Import-Test > Section: Module 3: Document Control

Module 3

What are the consequences of non-compliance to Document Controls?

Failure to adequately comply with certain provisions of Document Control can lead to FDA citations. From a company compliance standpoint, the FDA website can be accessed to view current medical device industry compliance. This information is useful to review to help determine if there are potential compliance gaps in a firm’s quality system. The ability to access and review this information is important because the information can provide an advance notification regarding what to expect if the FDA inspects your facility.

The frequency of occurrence of citations is a leading indicator as to where the FDA will focus attention when conducting on-site inspections.

In this section we will explore the frequency of inspectional observations (by category).

Referring back to module one regarding FDA enforcement and the frequency of inspectional observations, let's look at the leading inspectional observations for 2015.

Read

Read FY 2015 Inspectional Observation Summaries to review the top six inspectional observations for 2015.

As you can see from the reading, the top 6 enforcement observations are written against different sections of the regulations for failure to define, create or document procedures. Although Document Controls is not specifically mentioned in any of these inspectional observations - Subpart D requirements are a critical quality system interdependency with a direct link to each observation.

Read the Warning Letter on the Inspections, Compliance, Enforcement, and Criminal Investigations page to see an example warning letter about non-compliance to Document Control requirements.