The purpose of an Audit Trail for Electronic Record systems is to provide assurance of the integrity of the Electronic Health Records and the associated Raw Data.
Although the FDA has stated that it intends to exercise enforcement discretion in relation to audit trail requirements in the 21 CFR Part 11 Guidance to Industry (2003) there have been a number of observations relating to the integrity of records and data since 2003 (see CSV FDA Warning Letters). These have been cited against 21 CFR 211.68.
Why Should You Attend:
This 90-minute webinar discusses the compliance requirements for regulated companies in relation to electronic medical record system, electronic patient record integrity and the use of Audit Trails for computer systems.
Areas Covered in this Webinar:
Compliance requirements for regulated companies
Regulatory requirements (FDA, MNHA/EU Annex 11)
Assuring record Integrity
Systems with Audit Trails
Systems without Audit Trails
Content of an Audit Trail
Learn what audit trails are and how they are established
Learn compliance requirements for regulated companies
Learn regulatory requirements (FDA, MNHA/EU Annex 11)
Learn how to assure record Integrity
Learn the benefits of systems with audit trails
Learn the how systems without Audit Trails may be incompliant
Who Will Benefit:
Senior Quality Managers
Document Control Specialists
Upon earning a degree in Zoology at North Carolina State University, Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their quality control lab.
In 1998, Ms. McElroy moved to Wyeth Lederle and worked in quality assurance, performing GMP compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in quality assurance for a few years, she moved into equipment qualification and cleaning validation at Mallinckrodt.
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