CTG Academy

Introduction to Electronic Records and Electronic Signatures (ERES)


Introduction to Electronic Records and Electronic Signatures (ERES)
Start Date:
9:00 AM - 5:00 PM
CTG Belgium ( be )
Price excl. VAT:
€ 910,00
* Prices subject to VAT

day 1

The Life Sciences industry is one of the most regulated industries in the world and is subject to regulation by different government agencies. Pharmaceutical, biotechnology, clinical research, medical device and healthcare companies are required to meet relevant GxP requirements for their business operations, which involves well-trained personnel.

Some of these GxP requirements are applicable to GxP critical records and signatures. When those critical records and signatures are kept and managed electronically, specific regulations apply. For products sold in the US market 21 CFR Part 11 applies. For products sold in the European market, the electronic records and signatures have to comply with EudraLex Volume 4 Annex 11.

CTG can provide training to your employees to ensure they are appropriately trained and have adequate skills and experience to work with and manage electronic records and electronic signatures in an efficient and compliant manner.


Currently no (other) upcoming dates are planned for this course


Course Objectives

The goal of this course is to provide understanding of common quality practices for electronic records and electronic signatures (ERES) applicable to GxP environments. The training also provides a reflection of regulatory expectations for computer systems that use electronic records or signatures. This training discusses further on the concepts and requirements of ERES and provides details on the remediation of ERES compliance gaps.

Each participant will have gained knowledge about:

  • The background and intent of ERES rules
  • How to identify electronic records and electronic signatures
  • How to identify the most ERES issues that are resulting in regulatory citations
  • The ERES assessment process
  • How to manage corrective actions for ERES compliance gaps

Typical Audience

The “Introduction to Electronic Records and Electronic Signatures Training” course is designed for Business, QA and IT personnel that are new to electronic records and signatures. It is important, and is also a regulatory requirement, that all individuals working within the Life Sciences industry receive GxP training and are capable of performing their assigned duties.

Course Prerequisites

A basic knowledge of English is required.

Course Delivery

The training is given in a classroom format and is structured to offer flexibility and to cater for participant needs and circumstances by considering prior learning and level of staff experience.

Courses can be given in English or in Dutch. Course material is in English.

Course Venue

The course duration is 1 day.

This course can be given at the client’s site or at CTG.

Course Administration


€ 910 per person for one day
€ 850 per person on second subscription for the same company
€ 750 per person on third (or more) subscription for the same company

All prices are VAT excluded; course material, lunch and beverages included.


  • By Participant: If a subscribed course participant is replaced by another participant or if the public course is postponed to a later date, no cancellation costs apply. A participant or a group that fails to attend, or that cancels a course without at least 15 working days written notice prior to the course start, is liable for the full subscription cost.
  • By CTG: CTG reserves the right to cancel a course at any time.

Course Logistics

This classroom cours begins promptly at 9 am and is scheduled until 5 pm. All courses are organised at the CTG premises in Diegem (Belgium).

All courses can be given at the client’s site and are available for groups as well. Please contact us if you wish further information.

* Prices subject to VAT

Course Outlines

Introduction to electronic records and electronic signatures: part 1

  • Applicable government regulations
  • ERES – Part 11 Subpart A
  • ERES – Part 11 Subpart B
  • ERES – Part 11 Subpart C

Introduction to electronic records and electronic signatures: part 2

  • Predicate Rules
  • ERES Assessment Process
  • Typical regulatory citations
  • Managing ERES corrective actions

Meet our trainers

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CTG Belgium NV

Culliganlaan 1D
phone: +32 2 720 51 70
fax: +32 2 725 09 20


Buffalo,New York
300 Corporate Parkway
Suite 214N
Amherst, NY 14226
phone: +1 716 882 8000
fax: +1 716 887 7464

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