Minerva Imaging

Minerva Imaging accelerated the employee onboarding process by 50% with SimplerQMS.

Minerva Imaging Case Study







Company Size

51 – 200 Employees

About Minerva Imaging

Minerva Imaging, established in 2011, is a company that operates both as a Contract Research Organization (CRO) and a Contract Development and Manufacturing Organization (CDMO). Minerva Imaging specializes in developing radiopharmaceutical candidates, focusing on pre-clinical work for its clients and assisting in advancing molecules to clinical phases.

The CDMO segment of Minerva Imaging operates under strict Good Manufacturing Practices (GMP) requirements and is accredited by the Danish Medicines Authority. Minerva Imaging CDMO complies with the European Medicines Agency (EMA) guidelines and United States Food and Drug Administration (FDA) regulations, emphasizing the commitment to complying with international quality and safety requirements.

Minerva Imaging has effectively integrated SimplerQMS into its daily CDMO operations, utilizing the electronic Quality Management System (eQMS) to facilitate compliance with the applicable requirements. The implementation of SimplerQMS also enabled Minerva Imaging to streamline quality management processes, ensuring robust document management, traceability, and effective audit preparation.

“The buzzword for a digital quality system is effectiveness. Because by eliminating paper, you can become more optimized on your operations, especially to get a tamper-proof system in relation to all key features that the document management system requires.”

Pablo Moreno

Director of Quality, Minerva Imaging (CDMO)

Key Challenges Before SimplerQMS

Proactively avoiding potential challenges, Minerva Imaging implemented SimplerQMS to establish a robust system. The implementation from the outset helped ensure smooth operations and compliance with Good Manufacturing Practices (GMP) requirements.

Frequent inspections and audits from clients and regulatory authorities necessitated high adaptability and compliance in required quality management processes. Furthermore, the dynamic and rigorous environment of GMP requirements stressed the need for an effective system to manage and integrate various operational aspects.

Minerva Imaging also required fast onboarding of new employees. Due to high employee turnover in the pharmaceutical industry, minimizing onboarding time was crucial for maintaining smooth operations.

These challenges highlighted the need for an electronic Quality Management System (eQMS) like SimplerQMS to streamline operations and enhance effectiveness in quality management.

“You can never reach that level of effectiveness in terms of being compliant and, at the same time, being very thorough in document management without a digital system nowadays. Everything is so dynamic that, on paper, you always lose track.”

Pablo Moreno

Director of Quality, Minerva Imaging (CDMO)

Key Implementation Goals

Streamline operations by introducing a tamper-proof system for document management, including robust version control and approval workflows.

Facilitate seamless integration among system modules for improved management and tracking of equipment, documents, audits, and other modules.

Optimize onboarding processes for new employees, minimizing the time and resources needed for training on essential procedures.

Provide easy access to electronic documentation and real-time display during audits, showcasing transparency and operational efficiency.

SimplerQMS Implementation

The implementation of SimplerQMS at Minerva Imaging was meticulously planned and executed through a structured three-phase process. Each phase contains the deployment of specific QMS modules.

The implementation process was tailored to meet the unique operational needs of Minerva Imaging and GMP requirements.

SimplerQMS provides a streamlined implementation process typically completed within 5 – 6 weeks. A unique phased implementation approach ensures a smooth transition, with clearly defined milestones for each stage.

The SimplerQMS system implementation phases for Minerva Imaging were as follows.

  • Phase 1: At the outset, a detailed plan was drawn up, focusing on the unique operational framework of Minerva Imaging. Phase 1 included the kick-off, system configuration, and training. Simultaneously, the team at Minerva Imaging began drafting documents within the system, setting the groundwork for operational use. User licenses were allocated during this phase, training for Document Control and Training Management modules was performed, and the respective modules were deployed.
  • Phase 2: Phase 2 comprised the QMS module training for Equipment Management and establishing a Supplier List and Projects and Archive. Following the completion of training for these modules and capabilities, the corresponding go-live process for those components was initiated.
  • Phase 3: In Phase 3, Minerva Imaging initiated the finalization of training for Change Control, Audit Management, Supplier Management, Customer Management, Deviation Management, CAPA Management, and Product Management, alongside the deployment of these modules. In this phase, the implementation records are stored for compliance purposes, and the entire QMS software is officially operational, marking the system ready for real-world application at the organization.

Throughout each phase, the SimplerQMS team members closely collaborated with Minerva Imaging to ensure the system was precisely configured to meet its intended use, including integrating different system modules and streamlining the quality management process.

SimplerQMS actively assisted Minerva Imaging with the drafting of procedures, providing first-hand support and ensuring that each detail was perfectly aligned with the quality system.

The collaborative methodology promotes shared responsibility between SimplerQMS and Minerva Imaging, ensuring effective knowledge transfer and user adoption.

The SimplerQMS implementation process empowered the Minerva Imaging team for long-term success with the platform.

“The strategy of implementation proposal by SimplerQMS is very powerful. It provides a way of setting up the project in different phases. It is really what is required by the GMP.”

Pablo Moreno

Director of Quality, Minerva Imaging (CDMO)

The SimplerQMS Solution

The SimplerQMS solution provided Minerva Imaging with comprehensive modules designed to address quality management needs in the Life Science industry. Each module offered unique capabilities that helped improve the operations.

Audit Readiness

SimplerQMS supports audit readiness. The organized document structure facilitates audits by promoting traceability and easy access to relevant documents.

SimplerQMS system supported Minerva Imaging during customer audits and regulatory inspections with precision. Document retrieval during audits was easy and quick using search capabilities and document relation to specific regulatory requirements and related items in the system, making audit preparation easier.

Training Management

SimplerQMS Training Management module streamlines employee training, ensuring an effective, well-documented, and compliant training process.

Minerva Imaging was able to create targeted training groups, including employees with specific roles or from selected departments. The SimplerQMS system allowed Minerva Imaging to automate reminders and notifications for due or newly assigned training, empowering trainees to stay on track with their assignments.

Minerva Imaging utilized SimplerQMS’s SOP Management features to create readily accessible training materials. Employees electronically acknowledged their comprehension of each SOP in the read and understood process, creating a verifiable training record.

SimplerQMS System Validation

SimplerQMS provides fully validated QMS software according to GAMP 5.

SimplerQMS system also offers comprehensive support for quality management processes, supporting compliance with the Life Science industry requirements. For instance, Life Science requirements such as ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 11, 210, 211, 212, and 820, GMP, EU GMP Annex 11, EU MDR and IVDR, ICH Q10, and more.

SimplerQMS Customer Support

SimplerQMS offers extensive customer support, covering the entire range from the initial stages of implementation to continuous ongoing assistance.

“It is super important for a small company like Minerva Imaging that we have good support, and I think that is the key element.”

Pablo Moreno

Director of Quality, Minerva Imaging (CDMO)

Whenever Minerva Imaging required clarification on functionalities or encountered challenges, the SimplerQMS support team was ready to offer timely solutions and troubleshooting.

Integrated QMS Modules

SimplerQMS provides integrated QMS modules. Data automatically flows between modules, eliminating manual transfer and ensuring consistency across the quality system.

The integration between different modules empowered Minerva Imaging to effortlessly navigate between functionalities like document control, nonconformance and deviation management, equipment management, training management, CAPA management, and more.

“A very advanced feature of the system is the possibility to incorporate equipment, products, audits, and all modules that are special. And that level of integration (between operations and the system) really helps our operations.”

Pablo Moreno

Director of Quality, Minerva Imaging (CDMO)

Document Control

SimplerQMS Document Control capabilities streamline the handling of quality documentation, driving effectiveness and collaboration across the Minerva Imaging company.

The document control capabilities empowered Minerva Imaging to maintain audit-ready documents while accurately managing a high volume of data.

“You can forward whatever the inspectors the auditors are asking in relation to the inspection quite fast and quite efficiently. Documents are always digital, and you can do that in a matter of minutes.”

Pablo Moreno

Director of Quality, Minerva Imaging (CDMO)

The Results

Following the implementation of SimplerQMS, Minerva Imaging observed significant operational improvements.

These positive outcomes were evident across several areas.

Reduced 50% Onboarding Time

By implementing SimplerQMS, Minerva Imaging achieved a significant milestone in operational effectiveness, reducing the onboarding time for new employees by 50%.

Previously, the onboarding process took approximately two months. However, with SimplerQMS, this duration has been halved to just one month instead of two.

“In four weeks, you can have a very good read and understood process with a system that is easy to set up and user friendly.”

Pablo Moreno

Director of Quality, Minerva Imaging (CDMO)

By enabling quicker onboarding of new staff members, SimplerQMS helped ensure that Minerva maintained its operational effectiveness and productivity despite the challenges presented by frequent staffing changes.

Improved Audit Preparedness

The adoption of SimplerQMS significantly elevated audit preparedness for Minerva Imaging by providing a fully digital document repository.

By projecting documents on a large screen in real-time, Minerva demonstrated a level of transparency and readiness that genuinely impressed auditors.

“The good and the positive thing is that we already have electronically available documentation. So, we can forward whatever the inspectors and auditors are asking in relation to the inspection. And that is quite fast and quite efficient.”

Pablo Moreno

Director of Quality, Minerva Imaging (CDMO)

No Gaps in System Validation

SimplerQMS system validation process supported compliance with Good Manufacturing Practices (GMP), presented in requirements such as EU GMP Part I and EU GMP Annex 11, among others.

The system validation process ensured that Minerva Imaging remained ahead of compliance requirements without any gaps in validation.

“The system has been very effective in coping with the validation requirements. I have experience and expertise in the validation of SaaS systems, and I can tell that I am not fearing any gaps.”

Pablo Moreno

Director of Quality, Minerva Imaging (CDMO)

Continuous Customer Support

SimplerQMS Customer Support team provided Minerva Imaging with comprehensive assistance that covered essential aspects, such as system training, system configuration to align with specific operational needs, and quick troubleshooting to address and resolve any issues encountered.

The proactive and responsive support from SimplerQMS has been crucial in enabling Minerva Imaging to overcome challenges and improve quality management processes effectively.

“We are also getting the required support on troubleshooting because always something is not working as expected. This is without any exception to any process, and then you need to correct whatever is derailing in that sense, and SimplerQMS is supporting that.”

Pablo Moreno

Director of Quality, Minerva Imaging (CDMO)

Integrated Quality Management System

SimplerQMS module integrations exceeded the expectations. Particularly, the possibility of integrating the equipment management module with other modules like the product management, audit management, and other modules in the system.

The integration simplified document management and ensured that every piece of equipment was easily traceable and compliant with regulatory requirements, marking a considerable step forward in the quest for streamlined and effective quality management at Minerva Imaging.

“The degree of integration between the different modules of the system is very wide. Every equipment has at least three documents permanently linked to it and you can manage your equipment through the documents and vice versa.”

Pablo Moreno

Director of Quality, Minerva Imaging (CDMO)

Streamlined Document Control Processes

The implementation of SimplerQMS at Minerva Imaging streamlined their document control processes.

SimplerQMS system provides customized document views based on specific criteria, such as document status. This capability helped organize document priority actions.

“The possibility of having a tailored view of which documents you need to approve and which you need to review and classifying the information in that sense is very useful.”

Pablo Moreno

Director of Quality, Minerva Imaging (CDMO)

Additionally, the automated approval workflow facilitated a smooth and timely document review process, maximizing document management effectiveness.

“I think the core module of document management works very fine and very effectively. The document approval process is very intuitive and streamlined.”

Pablo Moreno

Director of Quality, Minerva Imaging (CDMO)

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