Quality & Compliance
Quality Assurance at iVRS holds an important place, where it is driven by top management and cascaded to every employee in the organization. As a ISO accredited organisation, all our systems and processes meets the requirements of ISO 9001:2015 and ISO 27001:2013 standards
QA department is an independent function and reports to the Management.
We have a dedicated QA resource for all the functions, who in turn is responsible for quality initiatives in their respective aligned functions and for maintaining quality standards, thus ensuring compliance to various regulatory requirements.
At iVRS, implementation of strict quality system is a norm and by far enhances the quality of the work carried out. The deployment of Quality Management System is a three-pronged strategy with a clear focus on Technology, Systems & Processes and People.
QUALITY POLICY
We at iVRS are committed to deliver error free and timely services to our customers in the field of clinical and non-clinical studies as per requirement of interested parties and adhering to quality, compliance & regulatory standards through continually improving competencies of our people.
Our QA team ensures that all the studies are conducted as per approved protocol, applicable regulatory requirements, in-house SOPs and other study specific standards.
iVRS maintains a robust Quality oversight on all our process through the following:
◘ Internal audit programs
◘ Multi-level approval for all Quality documents
◘ Documented 21 CFR Part 11 compliance for all systems
◘ Formal Corrective and Preventive Action (CAPA) process with Effectiveness Check system built-in for preventing future occurrences
◘ Robust Business Continuity Program (BCP) and Disaster Recovery (DR)
◘ Continuous ICH GCP & GLP audits and training programs throughout the company
Compliance :
Numerous laws and regulations govern Clinical research and development practices on regional, national, and international levels, and complying with these guidelines is a fundamental, yet complex building block of all activities involved in clinical research. Hence, compliance is one of the key element in a CRO and iVRS ensures that all the required compliance and regulations are adopted in all the operational documents across the organization.
Maintaining compliance with these laws and regulations will ensure that:
◘ The rights and safety of research participants are prioritized throughout your study
◘ Your clinical study data is accurate and trustworthy.
◘ Data generated at iVRS is Complete, Consistent, Enduring & Available or ALCOA
The studies conducted at iVRS meets the requirements of applicable regulatory standards, which it is intended to. The scientific and project management team has done extensive work for USFDA, EMA, WHO submissions and hence we are well aware of the regulatory requirements.
Information Security &
Management System
We are also a ISO 27001:2015 accredited organisation. At iVRS, since we deal
with a lot of confidential information of our customers and sponsors, we give
utmost priority for the data confidentiality and its security. Our entire systems
and processes are deployed as per the requirements of ISO 27001 standards.
All the applicable controls have been deployed to ensure your data is always
protected and secured from unauthorised users.
Let us talk
If you are an organization looking to engage a diligent, effective and reputed clinical research organization, you’ve come to the right place. InVitro Research Solutions was set up to help organizations like yours achieve integrity,
speed and efficiency in your research requirements.
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Address
Bangalore, India
Call Us
+91 80 45500700
Email Us
info@ivrs.org.in