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Computer and software validatio by Testo Industrial Services

REQUIREMENTS & PROCESSES

COMPUTER AND SOFTWARE VALIDATION.

Validation

Computer and software validation

Requirements & processes for companies in GxP-regulated areas

Computer system validation and software validation (CSV) ensure that procedures, processes or operations of computer-based systems lead to a reproducible desired result. Wherever you support or replace a manual process with a computer-based system, you must prove the suitability of that system.

CSV is a current and complex topic for companies in GxP-regulated areas (such as the pharmaceutical industry and medical engineering). The validation of these systems is prescribed by various standards and regulations, e.g. in DIN EN ISO 13485:2016, DIN EN 62304 or Annex 11 of the EU GMP guidelines, but implementation in practice initially appears difficult.

Our service to you

  • Integrated risk-based management of your validation project
  • Risk analyses in consideration of GAMP5®
  • Performance of the validation tests
  • Validation of the monitoring system (e.g. testo Saveris)
  • Consultation regarding product updates
  • Climatic mapping to evaluate the installation locations
  • Validation of the computer-aided system
  • Qualification of the measurement system
  • Risk-based change management
  • On-site calibration of measurement systems
  • Maintenance

For pharmaceutical and medical technology companies, it is advisable to define a pragmatic approach for the validation process and to always proceed in a practice-oriented and risk-based manner during the validation process. In general, software that is used within the framework of a quality management system must be validated. Such software is used in areas such as document, change or deviation management. Further applications can also be found in test equipment management or in the control of monitoring systems in warehouses and during transport.

Overview of regulations, standards and guidelines:

  • DIN EN 62304: Medical device software - Software life cycle processes
  • DIN EN 82304: Health Software Part 1: General Requirements for Product Safety
  • DIN EN ISO 13485:2016, Chapter 4.1.6: Medical devices - Quality management systems – Requirements
  • EU-GMP Guideline, Annex 11: Computer-based systems
  • 21 CFR Part 11: Electronic Records; Electronic Signatures
  • GAMP 5 Guide: Good Automated Manufacturing Practice Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture
  • PIC/S Guidance PI 041-1 (Draft 3): Good practice for computerised systems in a regulated GxP environment


Our experts support you in the validation of your computer and software systems.
Contact us – together we will create a software matrix and determine the validation relevance of the software used in your company. Finally, the validation of your systems is carried out according to a risk-based validation approach in accordance with the specifications of GAMP 5.

SUCCESS STORIES

Our references

More service, more security for your GMP compliance

What sets us apart

Expertise

Consulting, measurements, project management – our team with experience of the industry will support you precisely according to your needs

Technology

The use of our extensive test and measuring equipment with over 4,500 references ensures reliable measurement and test results

Documentation

We will hand over the documentation to you in person upon completion of the order in audit-proven layout or customised to requirements

Your contact

Please call us at:

Fon: +44 1420 544433

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