GXP Systems

Validation Services Our extensive range of validation services will meet your unique needs.

Validation

Stericycle GxP Solutions has a successful track record of introducing a right-sized validation approach to our life science customers. Whether it is introducing a new product, transferring a line, or bringing an existing line into a state of validation, our expert validation teams will provide you with up-to-date policies and procedures.

You will benefit from our right-sized validation approach.

 

Accurate Scoping
  • Inventory list preparation
  • Inventory classification based on risk assessment
  • Assessment of policies and procedures
  • GAP assessment
test

Equipment

Through our equipment validation services, we document the verification and qualification of all equipment as it is used in your manufacturing environment and ensure that the validation status of the equipment is maintained throughout the lifecycle of the validated system

CSV

Our computer systems validation services document the verification and qualification of all software and software-controlled systems as they are used in your operational environment. Through our services, we ensure that the validation status of each software element is maintained throughout the lifecycle for the validated system

Facilities

With a team of highly skilled engineers, possessing vast experience across electrical, construction and environmental engineering disciplines, GxP Systems has a multi-disciplinary approach to facilities validation services. Using this approach, we prove and document that equipment or ancillary systems are properly installed, function as designed, and lead to the expected results. This process will establish and provide documentary evidence that your premises, supporting utilities, equipment, and processes have been designed, installed and operate in accordance with the requirements of cGMP

Processes

GxP Systems performs validation of new processes, equivalent processes, process improvements and process changes to be introduced into your manufacturing area—all while meeting the domestic and international regulatory compliance requirements for process validation.

Supply Chain

With the increased emphasis on supply chain quality, companies are finding it a challenge to ensure their supply chain is compliant with all regulations. We will execute through the supply chain validation process, including auditing, verifying, validating and monitoring, to ensure your suppliers’ processes and systems meet domestic and international regulatory compliance requirements.

Procedures

Our team of experienced life sciences consultants will help you with the development and design of compliance policies, processes, procedures and subsequent supporting documentation to suit your operational and regulatory needs.

Interested in our solutions?

Contact us now.

Contact Us

North Valley Business Centre
Old Mallow Road
Cork
Ireland
Phone: +353 21 4215 050

© 2018 Stericycle GxP Solutions