Systems GxP, data integrity, quality, validation

Electronic archiving (1 day)

 

Objectives of the internship

  • Know the regulations and standards applicable for healthcare companies in the field of electronic archiving
  • Define the concepts of electronic archiving, storage and backup
  • Be aware of the problems of electronic archiving
  • Acquire a simple methodology for setting up electronic archiving
  • Learn about the solutions available for electronic archiving

Teaching methods

  • Course based on ISPE ® and GAMP® guidelines
  • Concrete case studies
  • Work in sub-groups
  • Presentation and delivery of a summary document

Staff concerned

  • Responsible for production, IT, quality assurance and validation services in the pharmaceutical, medical devices, pharmaceutical chemistry and cosmetic sectors
  • Suppliers and subcontractors of these industries

Dates and costs 2021

Date: Contact us

Cost: 680€ excl. Tax including breaks and lunch

DETAILED PROGRAM

1 — REGULATIONS AND STANDARDS FOR ELECTRONIC ARCHIVING

  • Current regulations for electronic archiving: Part11, BPF, Part820, Part58 …
  • Applicable standards for electronic archiving: ISO15489, NFZ 42013
  • Regulatory guides: PIC / S Guidance, GAMP
  • Key points of the specific requirements for electronic archiving
  • Key points of the FDA’s new “Risk Analysis” approach for part 11

2 — PROBLEMS AND KEY POINTS OF ELECTRONIC ARCHIVING

  • Positioning of archiving in validation
  • Life cycle and process of electronic archiving
  • Key points to take into account for Archiving :
    • Reliability of recordings,
    • Security and integrity of archived data,
    • Criticality of data over time
    • Data migration
    • Data deletion

3 — SETUP METHODOLOGY

  • 5-step electronic archiving methodology
  • Development of the documents necessary for the different stages of the archiving process: risk analysis, security management, procedures, controls, validation

4 — PRACTICAL EXERCISES

  • Study of concrete cases of electronic archiving
  • Example of hardware and software solutions for secure archiving
  • Exercise of setting up an archiving process

Pre-registration :

8 + 15 =

 

Pharmasys is an approved organization (activity declaration number: 11 91 0806691) and listed in Datadock. It is therefore quite possible to go through your OPCA for the financing of the latter. You will find all the information you need to create your request for assistance in the training contract that will be sent to you.

We are at your disposal for any request for additional information.

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Contact

PHARMASYS GROUP
36, Place Nelson Mandela
91300 MASSY
Tel : +33 (0)1 69 35 05 43
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