Annex 11 – Computerised Systems

Description

PIC/S Annex 11 – Computerised Systems

Annex 11 – Computerised Systems: cGMP Certificate Training

PIC/S Annex 11 (computerised systems) describes GMP regulatory requirements and validation guidance for computerised systems used in pharmaceutical manufacturing and other life science sectors. It includes key information to comply with pending requirements in the updated EU & PIC/S Annex 11 (Draft) for validation of computerised systems.

• This interactive online PIC/S Annex 11 training module describes requirements for taking a risk-based approach to computerised systems and computerised system validation.
• Training in, and compliance with, PIC/S Annex 11 (Computerised Systems) regulatory guidelines is essential for all manufacturing, engineering, quality, and IT personnel who design, install, maintain, use and/or manage or update computerised systems in a regulated GMP environment.

Guidance in PIC/S Annex 11 applies to all forms of software and hardware used as part of GMP-regulated activities in the workplace.

This module describes the relationship between Annex 11, 21 CFR Part 11, and ISPE GAMP5 guidelines.

 

PIC/S Annex 11 eLearning: GMP Training Course Objectives

• To provide you with an understanding of the regulatory expectations for computerised systems based on PIC/S Annex 11 & EU Annex 11 guidelines (current and updated Annex 11 Computerised Systems Validation/GMP compliance requirements)
• To improve your awareness of risk management responsibilities relating to computerised systems including electronic records, electronic signatures, and computer audit trails
• To provide you with an overview of specific tasks and deliverables for GMP computerised system validation
• If your system uses Artificial Intelligence, Annex 11 as well as the new EU/PIC/S Annex 22 (AI) DRAFT will apply (after the drafts of the updated Annex 11 and the new Annex 22 on AI and are finalised in 2026).
• Note that Chapter 4 (Documentation) in the EU & PIC/S GMP Guide was also recently updated (DRAFT).

Annex 11 Computerised Systems – Latest Guidance

Course information

• Learners will be able to complete the PIC/S Annex 11 Computerised Systems (validation) compliance training course entirely online.
• Offering 24/7 course access for 12 months from the date of your purchase or assignment by your Organisation/Supervisor.
• Complete this training from the comfort of your home or office.
• Self-paced and convenient — learn at your own speed, in your own time.
• You can complete the course all in one session or over several sessions.
• Good internet access is required to complete this course and gain your GMP training certificate.

Annex 11 (update) – Computerised Systems, GMP compliance training (Certificate Course)

• Upon successful completion of the online assessment for PIC/S Annex 11 Computerised Systems regulatory compliance concepts, you will gain a Certificate of Completion for PIC/S/EU Annex 11 compliance requirements (one of over 75 GMP education presentation topics in our GMP eLearning options.
• This PIC/S Annex 11 Computerised Systems (Validation/GMP Compliance) Course Certificate can be saved/downloaded, printed, and included in your personnel records.
• The Course Certificate can also be attached to the person’s resume when seeking jobs in pharmaceutical and medical device industry job openings.
• It is recommended you follow this course with the GxP Computerised Systems training course to learn more about GAMP5 (2nd Ed) compliance expectations.

cGMP Training Materials including PIC/S Annexes

Other recommended GMP compliance training courses (certificate courses) for personnel working in the pharmaceutical industry and life-sciences sectors include:

• Good Recordkeeping Practice (GRK)
• Data Integrity & Data Governance requirements in GMP environments
• Annex 22 (Draft) – new guidance for Artificial Intelligence & Machine Learning in GMP facilities
• GxP Computerised Systems (Validation) based in GAMP5(2nd) standards/GMP requirements

Other GMP Training Presentations/online GMP courses:

• 10 Golden Rules of GMP – a brief introduction to GMP compliance
• GMP Refresher Training  – a certificate course learners should complete at least annually
• Good Manufacturing Practice (GMP) Part 1 Training
• Good Manufacturing Practice (GMP) Part 2

If you are working in the medical device manufacturing and/or medical software sectors, you should also complete the following courses as relevant to your product:

• ISO 13485 – Quality Management Systems for Medical Device Manufacturing
• SaMD – Software as a Medical Device

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• Note: Internet access is required to complete all online courses.
• Click here for 1-day intensive facilitated GMP compliance courses available via Zoom.