Validation Services

Trescal offers expertise in validation services.

We use the best in quality industry-standard validation equipment to provide reliable and repeatable results on every validation project. In precision instruments, lab equipment or specialized machinery, even minor discrepancies can cause problems and lead to inaccurate or incomplete results.

Our validation services begin with a validation master plan that defines the steps in each process. These steps can be categorized into three separate qualification categories, which include:

  • Installation Qualification (IQ) – The instrument, with all its components and documentation, is placed correctly and checked for performance according to the requirements.

  • Operational Qualification (OQ) – All the major parts of the instrument are tested to ensure they all perform correctly and are in sync with the entire system.

  • Performance Qualification (PQ) – The instrument is monitored over a period of time to check if it consistently delivers results within the required parameters.

Trescal engineers are experienced with using GAMP5 and ISPE approaches in executing automated and equipment validation projects. By deploying the streamlined process oriented methodology (POM) consistent with GAMP and ISPE procedures and templates, Trescal is able to simplify and control the cost of qualification and validation. We offer practical solutions based on ASTM E2500-07 and ISPE guidelines that provide quality and ensure a more cost-controlled, efficient project.

Our solutions and process oriented methodology applies the concepts and principles introduced in the FDA’s document titled ‘Pharmaceutical cGMPs for the 21st Century-A Risk-Based Approach’, and in the ICH Q8, ICH Q9, and ICH Q10 documents.

Instrument Validation