Electronic records and signature requirements


The use of electronic medical records and electronic handling of study data is common practice in research and is commonly assessed by study sponsors and CROs. To successfully utilize computer systems in clinical research requires a working knowledge of the basic requirements of 21 CFR Part 11 (ELECTRONIC RECORDS; ELECTRONIC SIGNATURES) compliance.   While this has been in place for approximately 20 years, do you know the basics?  Do you know when compliance with 21 CFR part 11 is required?  Do you know which computer system(s) used at Children’s Health meet the basic requirements of 21 CFR part 11?

It must be noted that this requirement applies when studies are conducted under the purview of the FDA, or have stated that they will adhere to part 11.

Here is a brief synopsis of title 21 of the Code of Federal Regulations part 11-governing Electronic records and signatures:

  1. Validation of the computerized systems must be in place
  2. There must be an audit trail
  3. System in place to address “Legacy Systems”
  4. Copies of Records must be reasonably accessible and useful
  5. Record Retention policies and/or SOPs are in place to address how the records will be handled.  Specifically addressing how the entity provides trustworthy, reliable and general equivalence to paper records and signatures executed on paper. The differences between the traditional paper system and an electronic system is significant. One must know and follow the Part 11 code. System validation has many items to follow but none more important than the who, what, and when aspect of the Data / Audit Trail. These trails must be secure, operator independent, computer generated, date & time stamped, and (most importantly) available for the FDA reviewer. SOPs and staff training is often what separates the “good” from the “not good” CRO or systems.

The electronic health record of Children’s Health System of Texas fulfills the requisites set forth by 21 CFR part 11, however, the FDA does not assess electronic health records to certify that they are compliant.  In Sept 2013, FDA released a guidance to the industry in which they state that EHRs won’t be assessed on 21 CFR Part 11 by the FDA and they instead defer to the regulations which govern EHR certification. Attached is an institutional Epic whitepaper addressing 21 CFR part 11 certification of compliance.

  1. The link to Epic’s ONC Health IT Certification details from the Epic website
  2. Link to the actual criteria specifications from the government that we had to pass for our certifications

From Epic’s standpoint, we can only provide the evidence/details of our system’s technical capabilities and that the technical capabilities support 21 CFR Part 11 compliance, not how an organization has implemented the system or operationalized any related processes. However, if a trial sponsor requires a letter restating this, we can provide that letter upon request. Please direct these requests to Michelle Hermann Director of Medical Records, Health Information Management at Children’s Health System of Texas.


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