Electronic Records and Electronic Signatures (ERES)


The 21 CFR Part 11 Regulation

Electronic Records and Electronic Signatures are utilised in Pharmaceutical and Medical Device industries as a means of meeting regulatory compliance requirements that are specifically outlined by the Food and Drug Administration (FDA) in the 21 CFR part 11 regulation, first published in 1997. The Pharmaceutical and Medical Device industries assume that your application or system is going to be 21CFR part 11 compliant, and thus it is not explicitly specified, as it is an expectation of Quality built into the system. 

The advantages of using Electronic Signatures are:

  • More efficient use of time
  • Lower costs
  • Follow the progress of files in real time
  • Secure access and identity of the signatory
  • Mobile friendly
  • Lower environmental impact
  • Reduces errors
  • Digital Transformation

To Ensure you are 21 CFR Part 11 Compliant the software application should adhere to the following:

1.Electronic Records

An Electronic record is any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.

The expectation is that Electronic Records in an Application or System:

  • must be able to output both on paper and electronically, to a file or files, electronic record data and their associated metadata.
  • must retain all original and modified electronic records.
  • must ensure accurate date, time and time zone stamps.
  • Non Authorized users shall not be able to alter the Application/System time, date or time zone.
  • shall reject invalid data (example character values in number fields, out of range values, etc.)
  • shall maintain a history which can be used to reconstruct the sequence events using the date and time stamp. All identified electronic records (s) have an associated audit trail.
  • must be able to capture the date, time, username of operator entries and actions that create, modify or delete application specific electronic records in audit trial including actions by system administrator (example changes to user access levels and privileges).
  • must provide the reason for the change as part of the audit trail for designated actions/activities on the System.
  • shall prevent all users, including administrators, from altering, disabling or deleting the audit trail.

2.Electronic Signatures

Electronic Signatures are computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.

  • Each Electronic Signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.
  • Electronic Signatures must contain information associated with the signing that indicates the printed full name, data and time of the signing and meaning (review, approve, author) of the signature.
  • The Application/System must assure that non-biometric electronic signatures consist of at least two distinct components such as an identification code and password.
  • The Signature should be permanently linked to the associated record.
  • The Application/System must check for sufficient authority levels before allowing a record to be signed electronically.
  • The Application/System must enforce the use of all signature components during the signing of an event.

Contact Us

At Dataworks all of our applications  that are used in a GxP environments are developed to ensure 21 CFR part 11 compliance. Our team of software and validation engineers have extensive experience operating in the life sciences sector developing and validating software systems and automation to FDA Standards – you can be assured that your software will comply with your required industry standards.

If you would like to learn more about how we can help you to ensure your systems and applications are compliant with CFR part 11 your  call us today on 051 878555 or email us at info@dataworks.ie

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