Quality Management System

Our Quality Management System (QMS) ensures that all of our GMP manufacturing activities comply with global regulations. This includes regulations from the FDA, EMA and CFDA in raw material and supplier control, manufacturing control, data integrity and control, GLP and GDP, etc.
Our GMP facilities, equipment and personnel are closely governed, monitored, and documented, to ensure that we can provide the best support to our clients throughout all stages of development and commercial production.

Integrity

MsHealth data managers are in charge of recording, compiling and accurate pre-processing of your trial data. Our highly qualified team is unafraid of new challenges and has often salvaged data that our clients thought irretrievably lost. Your data can be captured on paper and later double-entered by our personnel or electronically directly at the site. We perform data clean-up on computer and manually; there is never any doubt that our databases would not represent your case report forms. We can provide data and the corresponding documentation in CDISC SDTM and ADaM data format. We have adopted the validated, standard operating procedure driven processes, and vouch for the integrity and validity of your data

Guidlines

We adhere to GCP and ICH guidelines, standard operating procedures and other regulatory requirements. We carry out investigator site audits, database audits, systems audits, vendor evaluations. We also audit ourselves to prove the compliance with the norms and internal quality system. We continuously improve our processes through corrective and preventative actions and implement appropriate modifications to the quality system and standard operating procedures