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Computerized Systems Validation

Overview

Computerized Systems Validation has a long history in the pharmaceutical-  and the medical device industry.

The GAMP forum has established an industry standard that supports the pharmaceutical industy to create company specific validation and IT procedures.

Providing evidence of verification and validation activities is key in order to comply with the regulations. Computerized Systems Validation includes as well sound specification techniques, considering regulatory requirements such as ICH Q7, 21 CFR 11 early in the purchasing, development and implementation process.

Audience

Of huge benefit for all who want to participate in an IT project or want to be involved in the operation of a computerized system in the regulated area. Either as project manager, quality manager, business analyst, tester, user, operator.

Learning Objective

As validation lead you ...

  1. identify the required validation activities and deliverables,
  2. assess the quality of business and regulatory requirements,
  3. ensure traceability of requirements and system functionality to test cases,
  4. ensure that validation follows a life cycle model (e.g. GAMP5 approach),
  5. ensure proper evidence of validation activities is provided,
  6. assess the quality of the different development cycle artifacts (e.g. specifications, design, plans),
  7. Identify test objects, define the test strategy and write test cases.
Learning Steps
  1. You learn the basics and terminology of Computerized System Validation based on GAMP 5 
  2. According to the life cycle process of a system (from procurement to maintenance)
    • you conduct an initial risk classification of the system and assign a software category according to GAMP 5
    • you write the validation plan (considering risk and software category)
    • you create requirements and system specifications
    • you define aspects of the configuration and the programming
    • you develop the test plan and test specification
    • you document the test results and summarize them in a test report
    • you create the final validation report.
  3. You learn the minimum requirements for configuration-, change- and deviation management, training- and operational documentation
Pre-requisites for participants Duration

2 days

Costs

The 2 days standard module costs CHF 6'000.

Tailoring of the training agenda, the system context and the exercises  to be agreed on.
Alternative: Add a Mastery Learning Program to facilitate the learning success.

It is also possible to combine a 2-3 hours class room training a self-study session.