PHCEU Validation Services

PHC can provide turnkey solutions for validation and qualification in accordance with all current regulatory requirements for pharmaceutical and healthcare equipment.

Validation is a fully-documented process that demonstrates any PHCbi system or product meets defined regulatory requirements, using an approved set of documents to provide evidence.

PHCbi equipment can be validated with documentary support to comply with GMP, GLP, GCP, 21 CFR Part 11, PAT, ISO and other reevant internatiional regulations and guidelines, as well as to meet all specific customer requirements and applications.

Validation resources

PHCbi products and PHC facilities are certified to ISO 9001, ISO 14001 and ISO 13485 standards for quality, environmental management and medical devices.

Because key component parts are designed and built in-house by PHC, it can offer precise and in-depth validation resources specific to PHCbi laboratory products. PHCEU can also provide comprehensive expertise in laboratory equipment to exact compliance needs. PHCEU validation systems employ advanced technology coupled with the latest trends to insure compliance with accurate and time efficient completion.

Using PHCEU validation services

Customers can obtain validation for any PHCbi biomedical equipment, either through PHC Europe B.V. directly, or through local certified distributor. Either way, it is simple to set up a validation request online (see Resources).

All PHCEU distributors are inspected and apporved as meeting BHS’s high quality and service standards, with PHC Europe B.V. certified engineers, fully trained in all PHCbi products.

Resources

Click on Validation Request to begin process.