When Team Horizon’s Pharmaceutical and Medical Device clients need to build a new or retrofit a production facility, or commission and qualify new equipment and systems, they turn to our industry experienced engineers for practical qualification and validation support.

For qualification and validation, our customers need a partner that can coordinate the customer’s project qualification team onsite and provide full support to its validation activities. 

We apply the complete “Quality Package” (URS/DQ/FAT/SAT/IQ/OQ/PQ) for both conventional and QbD-developed products.

The key to successful verification of a facility project is a clear quality risk management approach.

Team Horizon coordinate all the qualification activities to ensure they meet both regulatory requirements and the client’s needs. We also support the validation process, controlling and approving validation reports and protocols as well as change control activities.

Team Horizon utilize their expertise in Quality Risk Management, in-depth technical knowledge, Good Engineering Practices and vendor involvement to ensure that the level of effort, formality and documentation of the quality risk assessment process is commensurate with the level of risk to the patient.

We ensure our clients can benefit from a flexible validation approach, better use of expertise, extensive process knowledge and Lean documentation. We aim to eliminate repetitive testing and to involve subject matter experts (individuals with specific expertise and responsibility in a particular area or field such as the quality unit, engineering, automation, development and operations) to determine test principles and approve protocols and test results. 

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