IQ IT: Intelligent Quality through Information Technology

GxP: Good Practice for FDA-Regulated Industries

The abbreviation "GxP" here refers to a set of Good Practice regulations from FDA. While named "Good Practices," they are in fact legally binding regulations from a federal agency.

The Big 3 Good Practices for Pharmaceutical, Biologics, and Medical Device:

  • cGMP - Current Good Manufacturing Practice
  • GLP - Good Laboratory Practice
  • GCP - Good Clinical Practice

Information technology used in a GxP process or quality system must demonstrate accuracy, reliability, and suitability towards its intended use. This concept is described in several of the regulations governing Good Practices (examples below).

Enter Computer Systems Validation and 21 CFR Part 11.

Computer Systems Validation (CSV), in very general terms, demonstrates through documented evidence that a system meets pre-deteremined requirements and will successfully and consistently perform in its intended use.

21 CFR Part 11, 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).  Part 11 controls require the validation of systems (CSV).

Even when Part 11 does not apply, GxP regulations still require systems validation.

Part 11 doesn't apply to all electronic records created, modified, maintained, etc., by an organization subject to FDA regulations.  There is much confusion and great debate over the applicability of the intentionaly vague regulation.  Many companies get bogged down in the debate, lose sight over the fact that even in cases where Part 11 does not apply, GxP regulations still call for computer systems validation. 

Computer Systems Validation does not need to be an overwhelming undertaking when the proper approach is applied. 

When Part 11 does in fact apply, there are specific controls that must be demonstrated that may add to the scope of a validation.  But there are also methods to control the size of the validation effort.

Gray Matter Consulting can provide your organization with the expertise, skills, and experience to ensure that your GxP systems are compliant with the appropriate and applicable regulations:

  • Audit/Analyze existing GxP processes and systems
  • Interpret regulations specific to your organization and your systems
  • Attain and maintain compliance with Part 11 and applicable regulations
  • Develop internal policies and procedures for GxP computer systems
  • Implement industry best practices (GAMP) and quality standards (ICH/Q)

And with Gray Matter Consulting, we do it intelligently and efficiently, without wasting your time or ours.

IQ IT Intelligent Quality through Information Technology


FDA Predicate Rules and Validation

21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals, Section 211.68 describes the allowable use of computers in the manufacture, processing, packing, and holding of a drug product, and controls that must be exercised over the computer systems to demonstrate authenticity, accuracy, and reliability of the system and data.

21 CFR Part 820 Quality System Regulation(for Medical Devices), Section 820.70(i) states "When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented." 

21 CFR Part 11 Electronic Records; Electronic Signatures describes procedure and controls that must be employed to ensure the authenticity and integrity of GxP electronic records and signature; controls include Computer Systems Validation