GxP Computerised Systems

Description

Learn to comply with industry standards for GXP Computerised Systems (GMP-industry computers) including PIC/S guidelines and ISPE GAMP^®5 (2nd ed.) standards.

GxP Computerised Systems: Regulatory Compliance Training

Course Benefits – GxP Computerised Systems Course 

This cGMP training course provides a comprehensive understanding of GxP regulatory compliance requirements for computerised systems used in pharmaceutical manufacturing, clinical trials, and other regulated environments. This course is suitable for individuals responsible for selecting, installing, validating, maintaining, updating and revalidating pharmaceutical industry computer systems & components, firmware and software upgrades. It is available in a completely online training format that provides learners with a Certificate of Completion (cGMP Training Record) for GxP Computerised Systems (an essential GMP education topic).

Course Overview

Gain insights into Regulatory Authority expectations for GxP Computerised Systems, including:
✅ PIC/S Annex 11 – GxP Computerised Systems Guidance (an introduction, as this topic is covered in a separate course)
✅ ISPE GAMP®5 (2nd Edition) – Industry best practices for Computer System Validation (CSV)
✅ FDA & EMA Guidance – Regulatory expectations for computerised systems compliance
✅ Risk Management & Data Integrity Principles

This self-paced online course provides practical guidance on GxP computerised systems validation (CSV) regulatory compliance requirements, risk-based approaches to computerised system validation, and pharmaceutical industry best practices for GxP systems compliance.

Who Should Take This Course?

This GxP Computerised Systems (regulatory compliance) training course is designed for anyone responsible for choosing, validating, testing, using, maintaining, updating and/or revalidating computerised systems or software in GMP environments, including:
✅ Quality Assurance & Compliance Teams
✅ Computer System Validation (CSV) Specialists
✅ IT Professionals & System Administrators in GMP/GxP Environments
✅ Process Owners & System Owners
✅ Manufacturing SMEs, Operations Teams and Laboratory Personnel
✅ Operations Teams & Training Program Managers
✅ Clinical Trials Sponsors & Research Professionals
✅ Business Owners & Sponsors Responsible for GMP Compliance

Key Learning Topics

📌 GxP Compliance for Computerised Systems – Understanding key regulatory requirements
📌 GAMP®5 (2nd Edition) Principles – ISPE guidelines for computer system validation
📌 PIC/S Annex 11 & Regulatory Authority Expectations – FDA, EMA, MHRA, TGA
📌 Risk Management & Data Integrity – Ensuring compliance through governance
📌 Validation of Software, Hardware, and Processes – Industry best practices
📌 GxP System Specification, Design & Development – Key responsibilities
📌 System Verification, Testing & Configuration – Fit-for-purpose requirements
📌 Computer System Validation (CSV) Activities – Ensuring regulatory compliance
📌 GMP Audits & Inspections – Meeting regulator expectations for GxP systems

GMP Compliance Training Programs

Why This GMP Education Topic is Essential Learning  

Regulatory bodies such as the FDA, EMA, MHRA, TGA and other Regulatory Authorities require strict compliance with GxP computerised systems validation.

This GxP/cGMP eLearning course provides essential training on:

✔️ Best practices for validation, risk management, and maintaining data integrity
✔️ Understanding the role of computerised systems in batch traceability & manufacturing compliance
✔️ Regulatory expectations for system design, validation, and ongoing system maintenance
✔️ Compliance requirements with ISPE GAMP®5, and regulatory guidelines such as PIC/S Annex 11(detailed guidance for Annex 11 is provided in a different course, visit the Store menu item to browse regulatory compliance courses by GMP Education Topic/Title)

Note: PIC/S Annex 11 – Computerised Systems guidance is covered in a separate course and both modules are recommended, along with Data Integrity training.

GxP Computerised Systems Course 

This course is essential for professionals responsible for GxP computerised system compliance, validation, and regulatory adherence in the pharmaceutical, biotechnology, and medical device industries. Completing this course will help you learn the regulatory expectations for industry computer systems including computer system validation requirements detailed in GAMP5 (2nd Edition), Annex 11, and other guidelines.  

This online GXP/GMP course is best combined with our Data Integrity cGMP training course and GMP Supplier Qualification online GMP training options.

Explore these courses in our online GMP eLearning courses.

Flexible Online Learning Format

This self-paced eLearning course allows participants to:
✔️ Access course materials 24/7 after purchase (valid for 12 months)
✔️ Complete the training at their own pace with practical case studies
✔️ Combine online learning with instructor-led training options (virtual or onsite, where available)
✔️ Note: All course prices are in US dollars. 

Certificate GMP Course for GxP Computerised Systems Compliance

• Successful completion of the Final Assessment awards a downloadable/printable Certificate of Completion.
• This Certificate should be added to your GMP training records.
• You can also attach your GxP/Computerised Systems Validation training certificates to you CV when applying for job openings.
• The course takes approximately 4–5 hours to complete and is available 24/7 for 12 months per user license.
• If you are already familiar with these concepts, you may find you can complete this course in a shorter timeframe.
• Ideal for professionals involved in GxP-regulated computerised systems selection, validation, and maintenance.

How to complete this GMP compliance training course.

• Add the course to your basket and complete your purchase (US Dollars).
• One user/per licence purchase (12 months’ access).
• Check your emails (all folders) for log-in instructions approximately 5 minutes after your order payment is finalised.
• Search for and add the following domains to your safe sender’s list: “@onlinegmptraining.com” and @pharmout.net”.
• Complete the course and download your Certificate of Completion.
• Note: You can start and stop the course and pick up right where you left off (you do not need to complete the course all at once).

GxP Computerised Systems (Course Summary)

Course completion provides learners with a foundational understanding of the key elements of GxP requirements for all types of computer systems used in manufacturing, storage, distribution, batch tracing, and more in cGMP/GXP Manufacturing environments.

• Written in plain language, these courses help users understand what’s needed to comply with regulatory requirements for GMP/GxP computerised systems in pharmaceutical drug manufacturing environments and testing laboratories.
• It provides a robust overview of the essentials for regulatory compliance.
• You will also need to purchase your own licence to download the latest GAMP5 (2nd Ed) publication directly from ISPE.
• Review other top-ranked GMP courses and best-practice GMP training courses.

Additional GMP Training Program Resources

Online GMP Training Options for You and Your Team  

• You can purchase this GxP Computerised Systems regulatory compliance course individually OR in a training bundle.
• Bundled courses (purchasing several courses at one time) helps you save on your training budget.
• Just click the bundle tab and buy 4 or more courses in a single purchase, and save on your GMP Training Budget).
• You can also buy customizable bundles (20 or more courses) which permits you to assign specific GMP training topics to individual members of your team.

Get a quote for large training orders (100+ licences)

• Do you need to train your personnel to comply with Regulatory Compliance requirements, including having GMP-compliance training records for personnel?
• If you need to train large numbers of employees (e.g. from 50 to 1000+ employees), contact the Training Manager for a custom quote.
• Bundled training options let you ‘mix and match’ standard GMP compliance training courses and/or assign courses to different employees when required (enabling ‘just in time’ GMP training).
• Successfully completed courses provide online learners with a time-dated GMP Training Certificate for that specific GMP education topic.
• Note: All course prices are in US dollars. 

GxP Definition: The acronym ‘GxP’ stands for “Good x Practice”. GxP means a set of guidelines and regulations that ensure the safety and quality of pharmaceutical products, and is part of the Good Manufacturing Practice (GMP) suite of regulatory compliance topics.

Original guidance publications and standards are available from the following industry publishers:

ISPE = International Society for Pharmaceutical Engineering

ISO = the International Organization for Standardization

PIC/S = Pharmaceutical Inspection Co-operation Scheme