Quality Assurance

Quality Assurance serves as the major component of the Quality Management System (QMS). We think that putting a quality emphasis begins by building a solid base of Standard Operating Procedures (SOPs) that adhere to all relevant laws, policies, and guidelines. We put a strong attention on doing things right from the beginning and everyone is accountable for quality.

 All other departments are completely separate from the Quality Assurance (QA) Department at ECR. For the purpose of enhancing learning, it is essential to organize training sessions.

To ensure that your projects are completed to the utmost standards, our experienced Quality Assurance Department deploys Quality Management Systems. Our business has a significant set of SOPs in its Quality Assurance Department. Our quality assurance team is able to anticipate and eliminate any non-compliances from the very beginning of the project in order to guarantee data accuracy and consistency. Our quality assurance department is aware of the value of rules that have developed, and they have a process for putting the quality management system into action.

Additionally, QA departments determine the actual research processes that will be monitored, including the preliminary study design, site and data oversight, statistical review, and the final CSR. Internal and site audits are used to ensure compliance with ICH GCP, Protocol, SOP, and regulatory requirements. 

We have ability to manage the following quality assurance operations throughout the entire project life cycle:

 

  • Creation of SOPs and periodic upgradation.
  • Vendor Qualifications.
  • Conduct and Reporting of Internal and External Audits.
  • Periodic system audits to support ongoing system upgrades.
  • Respond to regulatory/sponsor inquiries, suggestions through CAPAs, and adapt and integrate our systems and processes as necessary.   
  • Internal reviews of research operations, data, and reports are carried out to ensure strict compliance, as evidenced by the regulatory agencies’ acceptance of regulatory dossiers.