21 CFR Part 11 Electronic Records and Electronic Signatures and Data Integrity

Regulations for ERES
The course covers, in detail, the requirements of the US 21 CFR Part 11 and European GMP Vol 4 Annex 11 regulations covering Electronic Records and Electronic Signatures. What each of the clauses of the regulations mean and the best means of compliance will be discussed and explained.

Guidance on 21 CFR Part 11
The FDA has issued detailed guidance on their expectations for the implementation of 21 CFR Part 11 and the level to which the regulation will be enforced. This course will explain this guidance in detail and propose a strategy for its application to both new and existing systems.

ERES Assessments
This section takes the participant through how an ERES assessment should be conducted and how the information gained from an ERES assessment should be used. It will involve practical examples that participants can complete on the day, thus leaving them ready to complete ERES assessments once they return to their workplace.

Data Integrity
This training course covers the FDA, WHO and MHRA guidance documents on Data Integrity and the implementation in practice of the guidance given. The training will cover the “ALCOA- Plus” principles of Data Integrity and their application. The training will cover the identification of “Critical Data” and Mapping the Data Lifecycle. The training will cover Data Integrity Assessments and Validation for Data Integrity compliance - both described in more detail below.

Data Integrity and ERES Assessments
This section takes the participant through how a Data Integrity and ERES assessment should be conducted and how the information gained from the assessment should be used. It will involve working on practical examples from the attendees’ work-place.

Risk Assessment
The training covers the application of risk assessment to the management of Electronic Records and Electronic Signatures, and Data Integrity, to ensure that the compliance effort is in proportion to the risk involved with the underlying process and the use of the data.

Implementation and Validation
The training covers the validation of both new and existing computerised systems for Data Integrity and ERES compliance in line with the approaches outlined in; the FDA Guidance on Computerised Systems Validation - 2002 and Computer Software Assurance - 2022, and GAMP 5 Edition 2 - 2022. Approaches to remediation of existing systems is also covered.

Personnel in the Pharmaceutical/Medical Device/Healthcare sectors who need to gain a solid foundation in the principles and practice of Electronic Records and Electronic Signatures and Data Integrity in a regulated environment.

Participants achieve the following learning outcomes from the programme;

• State the principles of Electronic Records and Electronic Signatures compliance.
• State the ALCOA Plus principles of Data Integrity.
• Apply the requirements of 21 CFR Part 11 in relation to Electronic Signatures and Records.
• Apply the requirements of the requirements of EU GMPs Vol 4 Annex 11 in relation to Electronic Signatures and Records.
• Apply the FDA Guidance on Data Integrity and relate it to the requirements of 21 CFR Part 11.
• Apply WHO and MHRA Guidance on Data Integrity.
• Conduct Data Integrity and ERES assessments.
• Identify “Critical Data”
• Map the Data Process
• Document Data Integrity and ERES requirements for new computerises systems and software.
• Determine remediation and validation approaches for QMS, Manufacturing and Laboratory systems.

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  John Lafferty

  John Lafferty is a Quality professional with over 25 years expe...

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