Biotechnology, pharmaceutical, and medical device companies develop highly complex products. For them, accuracy, consistency, efficiency, and quality are not goals; they are imperatives because the medicines, therapies, and devices they make can improve the quality of patients’ lives and safeguard their health.
On April 17, Arithmos with its partner Agatha Inc. hosted a complimentary webinar on Agatha – a cloud-based Quality and Content Management tool for Life Sciences and healthcare organizations. Agatha addresses the imperatives for their core business processes like managing clinical trials, optimising quality processes, and organising regulatory submissions. The system is highly configurable, allowing for tailored customizations that fit the company’s workflow.
The webinar was conducted by:
- Silvia Gabanti, Managing Director of Arithmos. Silvia has an impressive 15-year track record in the industry. She began her career in the CRO environment where she developed experience in applications for pharmacovigilance and clinical trials. On her career record, she also has extensive experience with Oracle applications – as analyst she was working with pharmacovigilance and clinical systems like Oracle Clinical.
- Guillaume Gerard, Chief Operating Officer of Agatha Inc. For the past 15 years Guillaume has been helping Lifesciences organizations worldwide to deliver cloud-based content management applications. His areas of expertise include the compliance aspects and architecture of such systems, as well as the functional expertise on the clinical document management side (Trial Master File) and Quality Management.
Continue reading to discover the questions from the Q&A session from the webinar.
What is Agatha’s policy for data backup?
Agatha handles all aspects of the data center operations, including regular backups of all data. All customer data are backed up daily, and daily backups are retained for 15 days.
It also provides the ability for customers to export all customer data (files, audit logs, metadata) at any time.
Is Agatha compliant with GDPR?
GDPR is a comprehensive privacy regulatory requirement. Agatha is fully compliant with the requirements in regard to how it stores data and collects information. There are some aspects of GDPR which are the responsibility of the business entity, for example naming a Privacy Officer.
Are document lifecycle statuses customizable?
Yes, lifecycle stages and other aspects of the review and approval workflows can be fully configured. That includes changing labels, adding steps, reordering steps and changing workflows from serial to parallel structures.
Are electronic signatures compliant to CFR21 part 11?
Yes, electronic signatures within Agatha are fully compliant with health authority requirements.Beyond signatures, Agatha is completely compliant with the FDA’s CFR21 Part 11. We maintain a CFR 21 Part 11 compliance checklist for every release of our service, and any customer can receive a compliance letter that can be used during audits.
Are activities tracked into an audit trail?
Yes, all activities are captured. This includes operations on documents as well as access and any change of settings. When an audit is performed, everything that has been collected in the audit trail process and stored can be provided directly to the auditor via a login with auditor access.
Is it possible to load data via an api from external applications (eg. eTMF, CTMS, EDC, …) and if yes, what kind of data can be loaded, only documents or also xml, json, xls?
It is possible – there is a full set of APIs available that allows data to be loaded, and external applications to be integrated.
Can documents have an expiration date?
Yes, documents can have an expiration date. This can be done using a “valid until” metadata, and processes can be triggered based on that metadata.
Could Agatha be used during the product development stages?
Absolutely. Many aspects of the Agatha solution are appropriate prior to the clinical trial phase, for example management of SOPs and collection of regulatory documentation.
Can Agatha manage the migration of legacy documents?
Yes, most projects include migration steps. There is an import tool that lets the client map data from a source system to Agatha and complete the import.
Is it possible to enable two-factor authentication (e.g. username & password plus SMS) in Agatha application?
Yes, two-factor authentication is the standard model for the use of Agatha. Two-factor authentication is enabled on a per-client basis.
Are there any penetration tests that could be shared with customers?
Yes, as part of Agatha hosting service penetration tests are conducted yearly. Reports and results are made available to clients during audits.
During the webinar it was mentioned that Agatha is cost effective. How does it price compare to the competition?
Agatha provides the best value among similar products because, as a ready-to-use and pre-validated system, it is less expensive to bring into product and on-board users. It also has lower subscription prices, because it does not operate on top of another product platform. It also has truly packaged modules, as it was shown during the webinar. Typically, it is 2 times more affordable than the competition.
If you are interested in a specific quote, contact us for a brief conversation. We will ensure we understand the specific functionality you need and the number of users and provide the best offer.