Systems GxP, data integrity, quality, validation

Validation of Excel applications (1 day)

 

Objectives of the internship

  • Know how to assess the conformity of an Excel application
  • Understand how to specify and document an Excel application
  • Perform risk analyzes of Excel applications simply, systematically and robustly
  • Know how to define the activities and the validation effort required for an Excel-type application
  • Determine the necessary degree of security of an Excel sheet

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 technical services, quality assurance and validation of the pharmaceutical, medical devices, pharmaceutical and cosmetic chemistry sectors
  • Suppliers and subcontractors of these industries

Dates and costs 2022

Date: Contact us

Cost: 680 € excl. Tax including breaks and lunch

DETAILED PROGRAM

1 — REMINDER OF VALIDATION CONCEPTS OF COMPUTER SYSTEMS

  • Current regulations regarding systems
  • Definitions, life cycle and validation activities
  • Key points of the FDA’s new “Analysis” approach for Part 11

2 — EVALUATION OF AN EXCEL APPLICATION

  • Key points to audit: identification of critical GxP data and functionalities, user, functional and design specifications required, security and integrity of critical data, SOP procedures, Part11 compliance
  • Tips for securing and ensuring compliance of an Excel application according to its use

3 — EXCEL APPLICATION VALIDATION PROCESS

  • Specifications: determining the type and content of the specifications to be carried out to properly document an Excel application
  • Risk analysis: simple and robust risk analysis methodology for systematizing risk analyzes of Excel applications
  • Maintenance of the validated state: implementation of procedures to maintain, control change control, save / restore and secure Excel applications.
  • Qualification: content of IQ, OQ protocols

4 — PRACTICAL EXERCISES / CONCRETE EXAMPLES

  • Audit and validation of several types of Excel applications: Quality System, Quality Control, traceability … with situational exercises
  • Determination of activities and validation documents to be carried out
  • Specification writing
  • Risk analysis
  • Drafting of IQ, OQ, PQ protocols

Pre-registration :

2 + 6 =

 

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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