Biotech QMS  – Quality management system for biotechnology enterprises by Agatha

Every industry and discipline has unique quality management requirements and frameworks. That’s why a generic quality management system that’s not designed for the pharmaceutical industry isn’t a good fit at all when addressing the requirements ( like the GMP or the GCP) of a biotech or medical device company.

Choose a quality management system made with Biotech and other pharmaceuticals businesses in mind.

Agatha Quality helps biotech organizations ensure the quality of their products and meet their quality objectives, while also maintaining a comprehensive record of all events and activities related to their manufacturing process. It provides a single platform to cover all your compliance requirements;  from validations to audit trails, to regulatory inspections and preventative actions, it can do it all. 

How can our QMS help your Biotech company 

As a biotech organization, you are constantly facing new regulatory requirements and the need to ensure the quality of your products and services. That’s why our Quality Management System (QMS) is the perfect solution for your organization. Our QMS is specifically designed for the biotech industry and offers a comprehensive platform for compliance, quality assurance and continuous improvement.


The best way to know if an Agatha Application meets your needs is to try it out. And good news – we offer Biotech businesses a free trial for Agatha Quality.

Comprehensive quality management

Our QMS includes a range of processes and practices, such as audit management and inspection management, to ensure your compliance with the industry’s regulatory requirements. It also includes a document management system, which helps you maintain accurate records of all your activities and decisions related to quality management, manage your quality policies and procedures, and track sources of non-conformances and complaints.  This is essential for providing evidence of your quality management processes and practices.

Powerful insights for continuous improvement

Our QMS includes powerful tools for continuous improvement, such as data analysis and corrective action planning. This allows you to identify areas for improvement and implement changes that will help you stay competitive and improve the quality of your products and services over time.

Adaptable and user-friendly

Our QMS is adaptable to your specific needs and requirements. We understand that every biotech company is unique, that’s why our platform is user-friendly and easy to navigate and if you have any difficulties our team of experts is always available to provide training and support.

Don’t let compliance and quality control issues hold you back any longer. Implement our Quality Management System and watch your biotech company thrive. With our QMS, you can ensure the quality of your medical devices and products, meet regulatory requirements, and exceed customer expectations. Our QMS is designed to help you achieve your quality goals and objectives, improve your quality operations and processes, and promote quality assurance throughout your organization.

Agatha Quality – A QMS for Biotech and all the Life Sciences

Effectively managing clinical, compliance, and quality processes and protocols is a mission-critical task at life sciences companies. Quality improvements accelerate trials and improve the results of clinical studies, while quality failures can result in huge delays, added costs and major disruptions. Choosing the right solution for monitoring and managing quality processes in clinical trials and pharmaceutical manufacturing is a critical decision. It’s time to look at Agatha Quality as the foundation of quality for your ClinOps and GMP program..

Agatha Quality (QMS) is a complete, ready-to-use quality management application for capturing deviations, documenting corrective and preventive actions (CAPAs), and managing change control processes during a clinical research project. Most vendors provide quality management forms that are targeted towards “widget” manufacturing, but Agatha QMS is focused on the key forms needed for ClinOps and life sciences GMP environments.

Risk-based monitoring and quality system

More than document management, our solution for biotech enterprises is an end-to-end quality management system. Combining forms, framework, documents, and workflows, Agatha QMS comprises a complete toolset for quality managers, preconfigured, validated, and ready-to-use but easy to adapt to specific process requirements.

How Agatha Quality supports compliance in Biotech

Advanced Forms

Work with ready-to-use standard forms and processes, or adapt them to support your needs. Forms include rich text fields that allow the addition of images and formatted text. Use the form designer to update the look and framework of your forms.

A dynamic, multipart form supports all steps in a process from deviation to change control, adding appropriate sections based on information provided at each stage. Reviews, approvals, and assignments for actions are also built-in to help businesses reach their quality objectives.

Complete Metrics and Reporting

Get all the reporting you need with built-in dashboards and reports, generate custom reports and export any report to Excel or a generic CSV format.

Cross Workspace Reporting: You can also create views and reports across workspaces and export results to Excel for dashboard reports.

Complete Records

Get complete quality records with signatures and audit trails, ready for inspection. Agatha QMS is fully compliant with 21 CFR Part 11 and EU regulatory requirements.

Agatha’s quality management application is also fully integrated with other Agatha applications, making it easy to create references between them (eg. A CAPA can reference an SOP).

More Than An Online Record

QMS forms in Agatha can be converted to PDF at any point, resulting in an appropriately-format, signed electronic record.

Biotech businesses get more with Agatha Quality

Basic Preview and Annotations

Preview and annotate PDF and Office documents, and images in Agatha Quality’s report form.

Advanced Integration Toolkit

Use Agatha’s Rest API to allow applications to upload or export items from Agatha (includes documentation and sample code).

Cross Workspace Reporting

Create views and reports across workspaces and export results to Excel for dashboard reporting.

An End-to-End Process

A complete, closed-loop process captured in an expanding form, from initial issue to preventative action.

Inspection Ready

Create complete quality records with electronic signatures, recorded approvals, and audit trails, all ready for inspection.

Full Compliance

A validated system that is compliant with GxP requirements, EU regulations, and FDA 21 CFR Part 11.

Learn more about Agatha Quality and our Biotech QMS

What is a clinical quality management system?

A clinical quality management system (CQMS) is a software application used for quality monitoring during clinical research by pharmaceutical companies. Clinical research requires a QMS, as a well-designed clinical quality management system will help ensure that all procedures, processes, protocols, documents, etc., that occur throughout the entire course of a clinical study are managed effectively and audited for quality.

How can Agatha’s QMS benefit Biotech organizations?

With the assistance of a clinical QMS, a organization operating in the biotechnology segment of the healthcare industry will be able to implement the applicable regulatory standards, concepts, and methodologies needed to achieve the goals of clinical research.

QMS applications like Agatha Quality also play an important role in keeping clinical research compliant with regulatory requirements by international regulatory bodies, such as Good Clinical Practices (GCP), the European Medicines Agency (EMA), and the US Food and Drug Administration (FDA), and others.

What are the advantages of a clinical QMS?

Improved patient and consumer safety

A clinical QMS generates reliable data that an organization, its partners, regulatory and healthcare authorities, and other stakeholders can use for monitoring and improving clinical products and the lives of patients. Using a clinical QMS such as Agatha Quality gives clinical trial participants and end users of the results of clinical research the assurance that medications/treatments that they receive were developed using proper research.

Guaranteed regulatory compli­ance throughout the research process

Managing quality through a central application ensures regulatory compliance during the entire clinical trial process. This risk mitigation will include first-in-human studies to post-marketing surveillance of new pharmaceutical products.

Improved clinical research quality management

Reduce or eliminate repetitive quality issues during clinical studies such as unintentional non-compliance, insufficient staff training, insufficient supervision by management, lack of protocol clarity, and insufficient quality control in the collection and recording of data threatening patient safety/data integrity.

Agatha Quality clinical QMS offers a strong organizational structure to help pharmaceutical businesses systematically improve the overall performance of their clinical research, accomplish their quality control and training goals and complete clinical trials efficiently.

Proactive approach to quality assurance

A reactive approach is not enough for a quality management software (CQMS): good risk management practices are essential. Proactively managing clinical quality with a well-designed CQMS instead of reacting to issues related to investigational products when they occur avoids wasting valuable time and resources.

What are regulatory requirements for drug development and clinical studies?

The main regulatory requirements for any project of clinical research or clinical investigation conducted by an organization are:

Good clinical practice (GCP)

“Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

The guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO).”

ISO 14155:2020

The ISO 14155:2020 “specifies general requirements intended to:

  • protect the rights, safety and well-being of human subjects,
  • ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
  • define the responsibilities of the sponsor and principal investigator, and
  • assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.”

European Medicines Agency clinical trials regulation

Regulation (EU) No 536/2014 states that:

“In a clinical trial the rights, safety, dignity, and well-being of subjects should be protected and the data generated should be reliable and robust. The interests of the subjects should always take priority over all other interests.”

What are the main elements of a clinical QMS?

The core elements of an effective digital quality strategy involve the following elements:

  • Processes;
  • Resources;
  • Roles and responsibilities;
  • Partnering;
  • Risk management;
  • Issue management;
  • Knowledge management;
  • Documentation that supports achieving quality;
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