How to implement 21 CFR Part 11, the regulatory guideline which deals with compliance for electronic records and signatures, is a challenge for professionals in the medical devices and pharmaceutical industries. The FDA has set out 21 CFR Part 11 to help the regulated industries that come under its purview to structure their business processes better, bring down turnaround time and reduce costs, and to establish standard procedures on how to implement 21 CFR Part 11.
Compliance with 21 CFR Part 11 is necessary for reasons that go beyond just ensuring IT security. It is also a solid and foolproof means to ensuring efficiency and economy of electronic records. 21 CFR Part 11 compliance for electronic records and signatures is also indispensable for ensuring patient safety. All these factors have led the FDA to require compliance with 21 CFR Part 11 electronic records and signatures.
Compliance with 21 CFR Part 11 is terribly tough, but mandatory
Compliance with 21 CFR Part 11, its good intentions notwithstanding, is quite complex. Companies that seek to transition to electronic records are hesitant and fearful of 21 CFR Part 11, because understanding how to implement 21 CFR Part 11very difficult and time consuming. It requires adherence to all the complex rules and protocols that the FDA has put in place. Entities that need to be compliant with 21 CFR Part 11 have to meet the requirements of the FDA which deal with data security and patient safety.
Yet, compliance with 21 CFR Part 11 is not optional. How does a company ensure implementation of 21 CFR Part 11 compliance for electronic records and signatures? What are the nitty-gritty and nuances of 21 CFR Part 11 implementation?
A webinar from Compliance4All
The specific ways of doing this will be imparted at a webinar being organized by Compliance4All, a reputable provider of professional trainings for all areas of regulatory compliance. Edwin Waldbusser, who has been consulting in the US and internationally in the areas of design control, risk analysis and software validation, will be the speaker at this webinar. To gain learning about 21 CFR Part 11 implementation, enroll for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501132LIVE/~sel=LIVE/~Edwin_Waldbusser/~21_CFR_Part_11_-_Compliance_for_Electronic_Records_and_Signatures
The speaker will help participants get an understanding of what 21 CFR Part 11 is and why it is important for industries to comply with it. The most important learning this webinar will impart is that it will help participants remove the fear and anxiety associated with ensuring 21 CFR Part 11 compliance for electronic records and signatures. This learning will help them approach this vital activity with confidence, so that they will not become targets of 483’s and Warning Letters that result from noncompliance.
A major topic Edwin will take up at this webinar is the rather stringent and punitive nature of this regulation. 21 CFR Part 11 was considered so harsh when it was introduced that it forced the industries that come under it to altogether give up on transiting to electronic records. Such was the fear and awe it incited. When industry made a plea to the FDA on this aspect, the regulatory body refused to dilute the severity of the requirements, but only said that it would take up implementation selectively. The speaker will talk on this aspect of 21 CFR Part 11 compliance for electronic records and signatures.
He will cover the following areas at this webinar:
o Company certification
o Records covered
o Audit trails
o Open/closed system access rules
o Electronic signatures