Annex 11 – Computerised Systems

Description

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:

• Add all courses of interest to your cart (consider training bundles for 4 or more courses).
• Complete the check-out procedure.
• Check your emails for your log-in information.

Visit the FAQ page if you have any questions.

• 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.

---