For Pharma companies, maintaining inspection readiness is essential.
Bringing pharma products to market means navigating a complicated path from the lab to the pharmacy while ensuring every step is in compliance with regulatory requirements. Agatha delivers a complete suite of applications that ensure inspection readiness at every step.
Supporting Clinical Operations
At Pharma companies, compliance with regulatory requirements is an absolute requirement, and maintaining inspection readiness is an absolute priority.
ClinOps leaders need to know that every document is in place, nothing is missing, and there is a complete audit trail of every action.
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
Pharma companies make products where quality is an absolute imperative. Lives depend on it.
Whether in the manufacturing facility, in the lab, or managed by a vendor, every incident needs to be tracked to resolution and every SOW and training record meticulously maintained. Agatha provides an end-to-end quality management system that 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 give you a complete toolkit, pre-configured, validated, and ready to use. And it can be easily tailored to your specific processes and needs.
“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.