Computerised System Validation - GMP Compliant Documentation - Online Training Recording

Computerised System Validation - GMP Compliant Documentation - Online Training Recording


ECA-Member*: EUR 1790,--
Regular Fee*: EUR 1990,--
EU/GMP Inspectorates*: EUR 995,--
APIC Member Discount*: EUR 1890,--

(All prices excl. VAT)

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail:


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


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 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 Details

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:

When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Training Course Documentation and Certificate:


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 Review
  • 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
Recording from 22-24 September 2021
Duration of the recording: approx. 13 h

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