Live Online Training: Computerised System Validation - GMP Compliant Documentation

Live Online Training: Computerised System Validation - GMP Compliant Documentation

Course No 19205


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Dr Rainer Gnibl, District Government of Upper Bavaria
Hannah Greiner, Epista Life Science
Yves Samson, Kereon


GMP-relevant computerised systems must be validated. The validation activities shall be sufficiently documented in order to allow inspectors as well as internal and external auditors to review and to understand the validation rigour and accuracy. The live online training will give an overview of the necessary qualification and validation documentation, including its structure and level of detail. The responsibilities of both suppliers as well as their regulated customers will be considered.


“What is not documented has not been done!” The accurate documentation of all CSV activities is the prerequisite for successfully passing regulatory inspections as well as customer audits. On the other hand, creating the documents and maintaining their integrity is also time-consuming and costly. Here it is important to find a balance between “as few as possible but as much as necessary”.

Target Group

This Live Online Training is directed at employees from the pharmaceutical industry and suppliers who have to prepare CSV documents and to document the validation activities of the computerised systems or who will have to carry this out in the future. Both beginners and employees with initial experience are addressed.

Technical Requirements

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.


Qualification Documentation Overview
  • Qualification / Validation Planƒ
  • System Descriptionƒ
  • Specificationsƒ
  • Requirements management / requirement traceabilityƒ
  • Risk managementƒ
  • Verificationƒ
    • Design Review, IQ, OQ, PQƒ
    • FAT, SATƒ
  • SOPs, agreements
  • ƒQualification / Validation Report
  • Qualification documentation scalability
Inspector’s Preconditions & Principles
  • Guidelinesƒ
  • Definitionen & Wordingƒ
  • Overall Responsibilityƒ
  • Essential PQS-Elementsƒ
  • Lifecycle Approach IT-Systemƒ
  • Good Documentation Practice (incl. ALCOA)ƒ
Computerised System Validation: From Quality to CSV SOP and CS VMP
  • Regulator expectations to the PQSƒ
  • PQS structureƒ
  • Quality Manualƒ
  • High level CSV SOPƒ
  • IT- / CS-VMPƒ
CS-VMP and Inventory Lists
  • CS VMP objective and purposeƒ
    • Planning / Reportingƒ
  • CS VMP structure proposalƒ
  • Management of the inventory listsƒ
  • Proposal for system classificationƒ
Inspector’s View to Structure & Documents
  • Validation Structureƒ
  • Documentation Structureƒ
  • Essential Topics Project Phase (Validation)ƒ
  • Essential Topics Operational Phase (Routine)ƒ
Supporting SOPs within a CSV Scope
  • What SOPs?ƒ
  • SOP structure proposalƒ
  • Recommendationƒ
Data-/Documentation Management & Integrity
  • Lifecycle Approach Data/Documentsƒ
  • Identification of critical data/documentsƒ
  • Lifecycle & Integrity Riskƒ
  • Data Governance Masterplanƒ
Qualification / Validation Plan
  • ƒObjectivesƒ
  • Responsibilitiesƒ
  • Structure proposal for a Qualification / Validation Planƒ
  • Critical aspectsƒ
    • Data flowsƒ
    • Identification of the GxP relevant dataƒ
    • Life cycleƒ
    • Risk managementƒ
    • Overall acceptance criteriaƒ
    • System releaseƒ
Qualification / Validation Report - System Description
  • ƒObjectivesƒ
  • ƒResponsibilitiesƒ
  • ƒStructure proposalƒ
  • ƒCritical aspectsƒ
    • ƒDeviation from the planned procedureƒ
    • ƒFailure and deviation handlingƒ
    • ƒMaintaining the qualified/validated stateƒ
  • ƒSystem Descriptionƒ
    • ƒObjectivesƒ
    • ƒResponsibilitiesƒ
    • ƒStructure proposalƒ
URS – User Requirements Specification
  • URS objectivesƒ
  • URS structure proposalƒ
    • Functional vs non-functional requirementsƒ
  • Responsibilitiesƒ
  • Recommendationƒ
Design Review: Supplier Documentation / Solution Selection
  • ƒDesign review objectivesƒ
  • Leveraging supplier effortƒ
    • Review of services offeredƒ
    • URS vs system functionalitiesƒ
    • URS vs system support, e.g.: SLAƒ
    • Quality and usability of the user manualƒ
    • Quality and usability of technical documentation
  • Design review report ƒ
  • Consolidation of the qualification/validation processƒ
FS – Functional Specification
  • FS objectivesƒ
  • How much is enough?ƒ
    • When is a FS required / needed?ƒ
    • What content?ƒ
  • Responsibilitiesƒ
  • FS structure proposalƒ
  • Recommendationƒ
    • Process workflow and user rolesƒ
    • Print-outs / reportsƒ
    • Audit trail entriesƒ
CS – Configuration Specification
  • ƒCS objectives
  • ƒResponsibilities
  • ƒStructure proposal
  • Content
  • Recommendation
    • When is a CS required / needed?
    • Configuration report vs Configuration Specification
Project Design Revie
  • Project consistency checƒk
    • Project approach
    • Documentatioƒn
    • Are the risk management outcomes properly taken into account?
    • Are the audit report measures properly implemented
  • Traceability matrix
  • Design Review Report
Testing Documentation: IQ / OQ / PQ
  • Installation Qualification (IQ) & Configurationƒ
  • Specification (CS)ƒ
  • Operational Qualification (OQ) vs Functional Specification (FS)ƒ
  • Performance Qualification (PQ)ƒ
  • Scalabilityƒ
  • Recommendation: How to leverage FAT & SAT results?ƒ
Q/V Project Close Down
  • Planning and supporting system handoverƒ
    • Closing the Project
      • Which documents are needed?
      • Which documents need to be updated?
    • Final system release
    • Previous System Retirement

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