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IQ/OQ - Software-Validation

Software validation – IQ/OQ

With the purchase of the ValSuite Pro software, customers receive the complete IQ/OQ documentation used to validate the ValSuite Pro software.  This document provides the end user with evidence that the software operates as intended and detailed documentation is supplied.  The FDA and GLP require companies to certify and validate their equipment. The Installation Qualification (IQ) and Operational Qualification (OQ) procedures are designed to meet these requirements. 

The validation can be time consuming due to the detailed nature of the protocol, but Ellab provides software validation services.  An experienced Ellab ValSuite operator can pay a visit to complete the validation and provide the proper supporting documentation.

IQ/OQ with Ellab

Scope of the GMP-compliant software validation of ValSuite Pro:

  • Support for IQ-, OQ- and PQ-procedure
  • Complete and proper documentation

FAT & SAT – Acceptance at the manufacturer and at the site

The FAT (Factory Acceptance Test) refers to the acceptance of a device or system at the manufacturer. It is usually carried out by the client and contractor or its agents and involves a review of integrity and functionality depending on the contract.

Subsequently there is the SAT (Site Acceptance Test) which is the approval of the device or system at the site of the customer. It includes a check-up of everything pertaining to the device and the completion of associated documentation.

FAT & SAT with Ellab

Scope of inspection:

  • Quality inspection of critical plant components before delivery
  • A quality inspection and a functional proof on-site
  • Complete and proper documentation

Expansion measurement for flexible packagings

Packaging deformities, damages or re-contaminations after the process are often caused by differences between the internal and the external pressure.

The Ellab E-Val Flex Deflection System features a deflection displacement transducer and a holding device for correspondent packaging. With this system it is possible to perform expansion measurements in standing and rotating sterilizers directly on the packaging. This is very practical when flexible packaging like pouches, foil dishes, plastic bottles or tins are used.

Expansion measurement with Ellab

Scope of expansion measurements:

  • Installation and performance of measurements on-site
  • Complete and proper documentation
  • Technical support
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