Annex 11 – Computerised Systems
Course duration: Allow 1 to 1.5 hours to complete this course.
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PIC/S Annex 11 – Computerised Systems
Annex 11 – Computerised Systems certificate training course
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.
The objectives of this training module are:
- to provide an understanding of the regulatory expectations for computerised systems based on PIC/S Annex 11 guidelines
- to provide an understanding of risk management in relation to computerised systems
- to provide an understanding of electronic records, signatures and audit trail
- to provide an understanding of tasks and deliverables for 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 date of purchase.
- Course duration: Allow 1 to 1.5 hours to complete this course.
- 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 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 the warehouse sector or for pharmaceutical and medical device warehouse job openings.
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 sector, see also:
ISO 13485 – Quality Management Systems for Medical Device manufacturing
SaMD – Software as a Medical Device
To order your online GWP certificate training course or other GMP education topics:
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- You can order a training bundle for multiple courses or contact us for arranging GMP training for large numbers of employees.
- Note: Internet access is required to complete all online courses.
- Or click here for 1-day intensive facilitated GMP compliance courses available via Zoom.