Agatha Secures Your Data
The security of your clinical and quality data is a top priority for us at Agatha. Get the details on how we do that here.
Your Data is Top Priority
Agatha uses world-class infrastructure and application-level security technology to protect the security and privacy of customer data on the Agatha cloud. The Amazon Web Services (AWS) data center, where Agatha’s applications are hosted, complies with international quality assurance programs such as SOC and ISO, as well as GxP regulations in the healthcare / life sciences industry.
Security Guarantee in Compliance with Laws and Regulations
Agatha employs Amazon Web Services. Designed to meet GxP regulatory requirements, FDA 21CFR Part 11, and high-security customers in the healthcare/life sciences sector, it guarantees data isolation and strong security.
Vulnerability Diagnosis and Invasive Test by Third Party
Agatha regularly diagnoses network, system, and application security by a third party. We have created an environment where customers can use our services with peace of mind by assigning dedicated security staff within the company to evaluate threats and take countermeasures.
In addition, we strive to improve personnel security awareness, technology, and knowledge and are working on security measures with a thorough system.
International Standard Certifications
“The decision to move to an electronic TMF and move its management in-house was the right decision for us. With Agatha’s help, we were able to configure an eTMF application that supports our needs today and can adapt with us as our processes evolve.”
Clinical Research Associate, InCarda Therapeutics.
Quality / Information Security Policy
Based on our management vision, “By improving clinical research procedures with technology, we will contribute to delivering new drugs to patients as soon as possible and reducing medical costs”, by providing a content management cloud service for the pharmaceutical and medical fields (“Agatha”). We recognize that ensuring quality and information security is essential to providing services that customers can use with peace of mind. We have established a basic quality and information security policy so that all Agatha employees are highly aware of quality and information security, act accordingly, and strive for continuous improvement.
In order to meet applicable legal and regulatory requirements, customer requirements, and requirements set by the Company, we inform all applicable employees of the importance of meeting these requirements.
When providing cloud services we securely manage important information such as customers’ confidential information and personal information to prevent it from being leaked, lost, damaged, or misused. We do not disclose business-related information beyond the specified range, even among employees. In the unlikely event of a violation, the disciplinary action stipulated in the work regulations will be applied. Also, when outsourcing, we take information security into consideration.
In business activities, we respond to the needs of stakeholders and provide content management cloud services that adhere to legal, regulatory requirements, and customer requirements in a timely and accurate manner.
We set quality and information security targets in line with this policy, maintain the achieved level through activities based on the PDCA cycle, and implement continuous improvement. In implementing this policy, we inform everyone, from officers to employees, of this policy and develop the necessary knowledge and judgment through daily work, education, and training.
Responding to Changes in the External and Internal Environment
This policy is evaluated and reviewed regularly through management reviews in order to respond to changes in our management vision and social conditions. In addition, in response to changes in the area of business activities, business content, information assets handled, information and communication technology, etc., we carry out reviews of the external and internal business environment and perform regular information security risk assessments to manage quality and information security.
Enacted: December 1, 2017
Revised: June 1, 2020
Chiemi Kamakura, President and CEO of Agatha Inc.
Interested in seeing how Agatha’s applications can help you improve your clinical and quality processes? Take one for a test drive.