IQ IT: Intelligent Quality through Information Technology

FDA Announcement: Part 11 Focused Inspections to Begin "Soon"

On July 8, 2010, FDA announced they will “soon” begin a series of inspections focusing on 21 CFR Part 11 requirements relating to human drugs.
“The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections that do not fall under the enforcement discretion discussed in the Guidance.”

“The Agency expects to begin conducting the Part 11 focused inspections soon.”

21 CFR Part 11, Electronic Records; Electronic Signatures, in general terms, is a federal regulation governing the use of and controls over electronic records created, modified, maintained, archived, retrieved, or transmitted under any FDA records requirement regulation (including GxP regulations).

Examples of GxP systems that create, maintain, transmit etc. electronic records are large scale laboratory information and clinical data management systems (LIMS, CDMS), as well as standalone PCs with simple software applications connected to laboratory instruments and data readers.  

Part 11 does not apply to all electronic records for a GxP compliant organization.

There is much confusion and great debate over the applicability of the intentionaly vague regulation.  Many companies get bogged down in the details and debate because they want to be compliant with federal regulations and implement the most efficient systems for their organization.

When Part 11 does apply, there are specific controls that must be demonstrated that may add to the scope of a validation, and companies need to be sure they implement those controls.

Let common sense and industry best practices prevail.

At Gray Matter Consulting, we apply our IQ IT approach to Part 11 compliance.  Utilizing our experience, intelligence, and industry best practices, we provide expertise in 21 CFR Part 11, FDA Guidances on the scope and application of Part 11, and leverage a risk-based approach to ensure focus on what's critical and that Part 11 controls...don't get out of control.

  • Assess/Audit your existing systems for Part 11 applicability and compliance. 
  • Interpret regulations as they apply specifically to your organization and your systems. 
  • Attain and maintain compliance with Part 11 and applicable regulations. 
  • Develop internal policies and procedures for your GxP computer systems. 
  • Implement industry best practices (GAMP) and quality standards (ICH).