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.

• 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 guidelines
• 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

Annex 11 Computerised Systems

Course information

• Learners will be able to complete the PIC/S Annex 11 Computerised Systems compliance training course (computer system validation requirements training) entirely online.
• Offering 24/7 course access for 12 months from the date of your purchase.
• Self-paced and convenient: learn at your own speed.
• Complete this training from the comfort of your home or office.
• You can complete the course all in one session or over several sessions.
• Internet access is required.

Annex 11 Computerised Systems Training (Certificate Course)

• Upon successful completion of the online assessment for PIC/S Annex 11 Computerised Systems regulatory compliance concepts, the learner will gain a Certificate of Completion for this GMP education topic.
• This PIC/S Annex 11 Computerised Systems (Validation/GMP Compliance) Course Certificate can be saved/downloaded, printed, and included in the person’s 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

Additional online training courses covering PIC/S GMP compliance topics for the life sciences sector.

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

• Good Recordkeeping Practice (GRK)
• 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
• GxP Computerised Systems (Validation)

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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Visit the online GMP training FAQ page if you have any questions.

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