MCT India Infotech Pvt.Ltd.

Asset Management’s role in 21 CFR 11 Compliance

Post By :- admin Date:- July 4, 2017

In August 1997, the United States Food and Drug Administration (FDA) issued a set of regulationsentitled 21 CFR 11 (Title 21 of the Code of Federal Regulations, Part 11). “These regulations,which apply to all FDA program areas, are intended to permit the widest possible use of

electronictechnology, compatible with the FDA’s responsibility to promote and protect public health.”

The regulations set standards for systems containing electronic records and electronic signaturesand standards for the use of such systems with respect to the release of safe consuma

bles intothe marketplace.With the inception of these regulations and the initiation of FDA enforcement, affected businesseshave scrambled to acquire automated systems that can stand up to the scrutiny implied by thestringent FDA requirements. Such businesses have met with mixed success—primarily because ofuncertainty with respect to the actual regulation provisions and because of false claims made byvendors about the regulatory compliance of their products. Enterprise Asset Management is the best solution, that meet or exceedall specifications found both in 21 CFR 11 and in its predicate rules—“predicate rules” beingprevious FDA regulations that are implicitly referenced by 21 CFR 11. In developing suchoperational strengths, EAM use 21 CFR 11 article by-article as the basic guideline to ensurethat an Enterprise passed muster for each and every regulatory demand.

Exceeding Requirements

Not only does Asset Management software available in the market comply with 21 CFR 11 requirements; in several areas of criticalinterest the application substantially exceeds the regulation. In surpassing FDA requirements EAM offers greater system flexibility, more user and administrative convenience, andsuperior operational security for process areas of greatest concern.

Examples of these excellent features include:

CGMP Asset Designation:The system allows the designation of equipment as being cGMP(Current Good Manufacturing Practices) Critical. This means that the equipment has an effect onproduct quality, safety, and/or potency and must be maintained with particular care. Subsequently,the system can be set to generate Electronic Records for work performed on cGMP equipmentonly. This reduces electronic Record administration because maintenance on non-cGMP equipmentdoes not generate such records.

PM Revision Control: EAM permits the set-up of approver groups that review allchanges to Preventive Maintenance (PM) templates, equipment routes, material lists, andtask lists before the system will allow these items to become active. This feature is importantbecause Preventive Maintenance is the cornerstone of cGMP maintenance. As such, the PMprocess must be safeguarded and scrutinized more thoroughly than other routine maintenance.

Inspection Revision Control:Similar to PMs, Inspections are protected byRevision Control so that sensitive inspection procedures, set points, and inspection routescannot be changed without thorough review. This feature adds an extra measure of safetyin this crucial maintenance area.

Calibration: Calibration is one of the few specific maintenance tasks mentioned in the context of21 CFR 11. EAM offers a full-service calibration program tailored for the FDA-monitoredbusiness. This calibration functionality and reporting package was designed with the assistance ofsome of our pharmaceutical industry customers so that its operations are fully compatible withFDA-compliance issues.

Qualification/Certification Registry: Often a task requires a worker who has special skills,training, or certifications. EAM offers a registry where documentation of such personspecificcapabilities may be recorded for an employee. Such a logging tool is useful enough,but EAM goes much further. When generating work items, a planner can actually specifyskills, certifications, or training required to perform an activity. The system can restrict who may beassigned to perform that activity based on a list of employees who have the required qualifications.This additional safety feature helps ensure the highest quality asset performance managementand is especially well-fitted for a highly regulated environment. These enhancements contribute significantly to safe, efficient, and effective business processeswhile continuing to support the principles of FDA oversight.

Validation: Validation is a crucial concern for FDA-monitored businesses. In essence, validation is proving thatan application reliably performs in the exact manner for which it was designed. This may soundsimple, but in reality companies sometime expend huge amounts of resources—in time, people,and funding—in order to execute and document system validation.Note the wording of that last sentence. It states that “companies” expend effort to validate. Manysoftware vendors tell prospective customers that their applications are already “validated.” This isdeceptive. No application is validated out-of-the-box. Validation dependsa great deal upon how a customer sets up and uses an application. In addition, some vendorsclaim that they will validate their application for the customer. Once again, this is contrary to FDAintent—because a vendor has a vested interest in executing a successful validation—even if suchvalidation fails to meet FDA standards. Validation should be performed and documented by thecustomer or by a neutral third party. There are numerous consulting firms that specialize in systemvalidation. This ensures objective evaluation of each validation point and provides for a validationprocess that will fully support FDA review.EAM Application has been validated by numerous customers at numerous sites. The system is so welldesigned and documented that EAM has never had difficulty receiving prompt validationby our customers—affirmed by FDA audits and inspections.


MCT is committed to superior asset performance management service within the context of FDAregulation and monitoring. We go beyond empty claims of compliance and seek to provide ourregulated customers not only with compliant applications, but also with functionally robust,flexible, and powerful solutions to their asset performance management needs.