Top image validation

Validation ensures safe handling of measurements and data.

Companies in GxP-regulated activities such as pharmaceuticals and medical devices need to validate their measurement systems to meet stringent requirements. Here you can read about what validation is and how we at Nordtec can perform it for you.

When we carry out a validation at a customer’s site, the aim is to provide objective evidence that measurement equipment and procedures meet the customer’s specifications.

– “By checking settings and performing simulations, we get results that give the customer black and white proof that important measurement functions and surrounding processes work as intended,” says Maria Almestål, lab manager at Nordtec.

Joint plan

It always starts with a meeting with the customer where we go through their measurement needs and which solutions and functions are important to fulfill their URS (User Requirement Specification). Based on this detailed requirement specification, we then plan how and when to carry out a validation to minimize disruption to the customer’s business.

– “Risk assessment, function and design are some important elements in the process that leads to the design of the customer’s measurement system, which we then carefully validate step by step,” says Maria Almestål.

The validation process

All validations are based on the customer’s URS. Maria and her team have an extensive list of checkpoints that are documented in both text and images.

In addition to a review of the requirements specification, an IQ (Installation Qualification) is often carried out. That is, a detailed review of the testo Saveris 1 measurement system to ensure that it is correctly installed with the right logs. OQ (Operational Qualification) is another variant of validation that aims to check, among other things, measured value flows and system times. If desired, we can also perform a PQ (Performance Qualification), which is a validation that examines the functionality at the user level of the customer.

Testing key features

Validation is a rather time-consuming but important job where we go through complex measurement solutions, test and verify safety.

– We check that all interactions in the system are traceable, that all measurement data is stored securely and cannot be manipulated. We test that alarms are triggered properly and that alarm messages reach the right recipients. “Passwords and access levels are two other features that are always tested, to give just a few examples of a long list of checkpoints,” says Maria Almestål.

Complies with standards and regulations

The results are presented in a validation report allowing the company to meet these requirements.

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