Pharma QMS for the pharmaceutical industry and Life Sciences

Our Pharma QMS software offers insightful tools for continuous improvement, such as data analysis and corrective action planning, to pinpoint problem areas and make adjustments that can boost productivity and raise the caliber of our products and services over time.

Because we are aware that every pharmaceutical company is different, our Pharma QMS software can be customized to satisfy any demands. Our team of industry experts and leaders is ready to offer training and support as needed, and the platform is simple to use and navigate.

Don’t let problems with quality control and regulatory compliance in the life sciences industry hinder the development of your pharmaceutical business. Use our Pharma QMS software to ensure the quality of your medical products and devices, comply with regulations, and go above and beyond what customers expect. Our system is intended to enhance quality operations and procedures, support quality assurance throughout your organization, and assist in achieving quality goals and objectives.

With the assistance of a clinical QMS, an organization operating in the pharmaceutical 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.

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

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.

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.”

The core elements of an effective Pharmaceutical Quality Management System involve the following elements:

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

Pharmaceutical Quality Management Systems for life science organizations are designed to improve efficiency, product quality, and time to market while ensuring compliance with common standards set by regulatory authorities.

A Pharma QMS software can streamline document management, training management, and preventive actions, leading to increased customer satisfaction and market success. Industry experts and leaders in the pharmaceutical industry recognize the importance of implementing a Pharma QMS to meet customer requirements and expectations while maintaining a high level of certification.

Tailored business solutions with Agatha Quality’s Pharma QMS Software

Agatha Quality’s Pharma QMS software offers tailored business solutions for pharmaceutical manufacturers and drug manufacturers, providing consulting services on manufacturing practices and ensuring a centralized database for future references. By minimizing human intervention and focusing on quality systems, Agatha Quality can help prevent drug adulteration and ensure the safety of human consumption.

Achieving compliance and efficiency with Agatha Quality’s Pharma QMS

Our Pharma QMS is trusted by industry experts and departments across the pharmaceutical industry, offering electronic signature capabilities and robust training management to keep your organization compliant and efficient. With Agatha Quality, you can take your pharmaceutical business to the next level and exceed customer expectations, while successfully navigating the ISO certification process.