Our GxP Training Service

Build lasting GxP skills across your teams

VeriData Advisory designs and delivers practical training in Data Integrity, CSV/CSA and computerized system control.

Each course is tailored to participants' responsibilities, your procedures and the situations actually encountered on the ground.

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Data Integrity CSV/CSA ALCOA+ Audit Trail Excel GxP GDocP

Our main training topics

Targeted modules to strengthen control of your data, systems and GxP practices.

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Data Integrity and ALCOA+

Understand data integrity principles, identify risks and apply ALCOA+ requirements day to day.

Computerized System Validation — CSV/CSA

Master the lifecycle of GxP systems, the risk-based approach and the principles of Computer Software Assurance.

Audit trails and periodic reviews

Define which data to monitor, organise audit trail reviews and document investigations.

Access, privileges and segregation of duties

Master user accounts, access rights, administrator accounts and segregation of duties.

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Excel and GxP office tools

Classify, secure and validate spreadsheets used in regulated activities.

Good practices for drafting and executing tests

Understand document management in Computerized System Validation, and learn good practices for drafting and executing test scripts.

Cloud, SaaS and GxP suppliers

Understand client and vendor responsibilities, expected evidence and the risks of outsourced services.

Inspection preparation

Prepare teams to present their systems, explain their practices and provide consistent evidence to inspectors.

Inspection preparation

Prepare teams to present their practices and provide consistent evidence.

Flagship training — The nine concepts of data integrity

This course goes beyond a narrow reading of ALCOA+ to cover the organisational, technical and human mechanisms behind data integrity.

1. Fraud and its impacts
2. Predicated Rules
3. Data, raw/source data and metadata
4. Heterogeneous and homogeneous data
5. Dynamic and static data
6. Limits of fully paper-based traceability
7. Good Documentation Practices — GDocP and ALCOA+
8. Segregation of duties
9. A system validated "for its intended use"

Training tailored to each audience

Content and exercises are adapted to the relevant roles.

Operators and technicians

Laboratory and production

Quality and Validation teams

IT teams and administrators

System Owners and Process Owners

Project managers and remediation teams

Managers and site leaders

Delivery formats

Sessions can be delivered on-site, remotely or in a hybrid format.

Awareness session

Short session to share essential concepts and build a common culture.

Targeted role-based training

Content tailored to a specific role, process or system.

Hands-on workshop

Analysis of real situations, exercises, case studies and identification of improvement actions.

Learning pathway

A programme made up of several progressive modules with skills assessment.

Train the Trainer

Training internal relays able to pass on and maintain knowledge within the organisation.

What you get

Depending on the format chosen:

Customised training materials

Exercises and case studies

Assessment questionnaire

Certificate of attendance

Summary of results

Improvement recommendations

Kit for internal trainers

Our method

We define learning objectives with your teams, adapt content to your context and assess participants' understanding.

1

Scope

Define learning objectives with your teams.

2

Customise

Adapt content to your context.

3

Train

Deliver training to the relevant teams.

4

Assess

Evaluate participants' understanding.

Let's build training suited to your challenges

An initial conversation will help identify audiences, expected skills and the most relevant delivery format.

Design your GxP training