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 for use of computerised systems. PIC/S Annex 11 guidelines for use of computerised systems also covers computer system validation requirements in the pharmaceutical manufacturing and life-sciences sector.

• 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 – Online GMP 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 – learn at your own training speed
• You can complete the course all in one session or over several sessions.
• Internet access is required.

Annex 11 Computerised Systems Training Certificate

• 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 the warehouse sector or for pharmaceutical and medical device warehouse job openings.

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

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

How to order GMP training

To order your online training course/other GMP education topics:

• Add all courses of interest to your cart
• Consider training bundles for 4, 6, or more courses
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  • Search your emails for ‘@pharmout.net’ and ‘onlinegmptraining.com’
  • Add those domains to your ‘safe senders’ or Contacts list

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.