Iperion believes that validation is not a goal on itself, but a way to take control of your systems or processes. This helps you to have more efficient, reliable and predictable systems and processes.

Iperion has highly qualified validation engineers with 10 years of experience in the Life Sciences industry.
We can help you manage, inspect, test and modify systems, software and processes and are currently developing a cloud based validation methodology.
We strive towards excellence in quality management with respect to right first time quality output.

 

We deliver validation in 2 areas:

 1 . Computerized System Validation (CSV)

We validate existing and new systems, located on premise, hosted / cloud based or mobile IT systems. We offer a start-to-finish solution for validation of computerized systems, according to GAMP5 (Good Automated Manufacturing Practice).

To ensure your computerized systems are GxP compliant, Iperion offers i.e.:

  • Drawing up (user) requirements and specifications ;
  • Assisting in / performing supplier qualifications;
  • Writing system descriptions;
  • Performing risk analysis;
  • Preparation and performing IQ, OQ and PQ protocols.

Cloud based systems are rapidly growing and require a different validation approach then traditional on premises systems. Iperion can help you with this new validation strategy, by setting up new requirements and software supplier assessment.

2. Process and Equipment Validation

On new and already existing production processes Iperion can help you through:

  • Writing or reviewing process descriptions and SOP’s;
  • Performing risk analysis;
  • Advising on process improvements by means of audits;
  • Validation of production-, analytical- and storage equipment;
  • Writing validation documents like a validation plan, validation protocols and validation reports;
  • Setting up good and meaningful reports and quality performance indicators.

Examples of validation projects:

  • Validation of a control system (Print & Verification) in an existing drug packaging line at a supplier in global market.
  • Validation of an ERP system in combination with a (cloud based) Warehouse Management System at a manufacturer and distributor to drugstores , regarding to the Good Distribution Practice (GDP).
  • Implementation, configuration and validation of several Quality Management System (MasterControl) instances at several European based customers.

 

Our validation consultants have:

  • Demonstrable experience in project management
  • Knowledge of and experience in GxP regulations such as EU GMP, GDP, GAMP5 and 21 CFR Part 11 and applicable ISO standards.
  • Analytical skills and the ability to find pragmatic and creative solutions to complex issues.
  • Knowledge of process optimization and project management tools.
  • Attention to detail.

Validation Contact

Please leave your contacts and your question and we will contact you shortly

    Please refer to our Privacy Statement.

  • This field is for validation purposes and should be left unchanged.

Or contact us directly

via phone +31 73 648  8000 or send an email to contact@iperion.com