Medical Device Companies have Unique Needs.
We call it MedTech now for a reason.
Today’s leaders combine physical devices with digital technologies and with therapies and formulations in new ways. The result is a range of automation needs that span manufacturing, regulatory and clinical operations domains.
Agatha has a complete suite of applications proven in use by MedTech leaders. Whether you are a manufacturer yourself or you outsource, we can address your unique needs to track operational processes and documentation.
Supporting Clinical Operations
To address those challenges, Agatha provides a complete, ready-to-deploy set of applications to streamline the management of Trial Master File content and processes.
Agatha’s Clinical applications provide all the functionality needed to manage every aspect of the TMF process and ensure inspection readiness. That includes the collection, management and tracking of all TMF (and ISF) content, automated information sharing between sponsors, CROs, and sites as well as tracking and reporting on a wide range of clinical trial information, including dates, milestones, sites, stakeholders and the status of expected documents.
Supporting Quality Processes
Instead, a complete end-to-end quality system is needed that is flexible enough to address each of those domains. Agatha provides a quality management system that addresses every process – from deviations to CAPA to Change Control – and is easy to configure, cost-effective, and can be implemented in a matter of weeks
By integrating forms, documents, automated workspaces, skills tracking, and employee training activities, Agatha’s Quality and SOP applications provide a complete framework for the entire quality process.
“Having the pilot is what made all the difference for us. It’s where we learned first hand what it was like to upload documents, to go through all the approval processes and all the different options, including any required configuration. I got to know the application and was able to provide feedback around my concerns, as well as understand what we would need to configure to meet our processes. So it was definitely crucial to our decision.”
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.