Quality
Investigation
Respond, Resolve Reduce
Investigate, Document and Improve Quality
the Minerva Way
Minerva’s RRR Quality Investigation Approach
(Respond-Resolve-Reduce) permanently avoids recurrence of process issues
The Minerva Team employs the Response-Resolve-Reduce (R3) approach for investigations, commencing with swift responses to issue backlogs, defining workflows, and organizing the resolution activities.
Minerva’s R3 approach (Response-Resolution-Reduction) to quality investigation provides a comprehensive solution to all your quality investigation needs.
This method entails a swift and effective response to the issue at hand, followed by a thorough resolution and the identification of measures to reduce the risk of recurrence.
With our R3 approach, you can trust that your quality issues will be handled efficiently and effectively, ensuring optimal outcomes for your business.
Our Rapid Response Team specializes in providing integrated solutions for quality investigations and risk management
See What You Can Get:
Rapid and effective response
through the use of analytical tools to help uncover the root causes of quality issues.
Timely resolution of quality problems
allowing allocation of dedicated resources to enhance efficiency and reduce turnaround times.
Reduction of backlog without compromising quality
and prioritizing cases based on risk, impact and regulatory requirements.
Continuous issue reduction
through root cause analysis and preventive measures while enhancing the investigation skills of your team.
Ongoing Quality Support Sustainment
to maintain process improvements for quality and productivity.
Laboratory-supported root cause analysis
for data management and analytics practices in order to help identify trends and patterns to address quality issues.
Process and Product Improvements for Issues Reduction
and in order to help foster a culture of quality and accountability inside your organization.
Visual Training Materials
to avoid recurrence of Human Errors.
Data-driven Investigation Resolution
We collect data from relevant operational parameters, and convert them into visual charst and diagrams to support the easy identification of capacity increase opportunities.
The visualized data serves to gather player feedback and to create better layouts, processes and systems, increasing capacity through productivity.
Talk about the supporting Team and its data driven approach to also support process improvements supported by the Minerva Laboratory.
Minerva uses visual language and infographics to effectively depict
your process to facilitate multi-disciplinary collaboration in the
investigation and reduction of quality issues
Human Error Reduction
as part of investigation and training integration.
Integrated Corrective actions
for operations, quality and compliance assurance.
Integrated QC and Operations Investigations
for integrated issue reduction.
All types of Investigations Covered
like manufacturing, quality Assurance, Quality Control, supply chain, traceability and chain of custody.
What Comes Next?
The team then proceeds to collect relevant process and quality information while aligning with Quality and Operations for fast investigation resolution using templates and previous investigations experience.
We ensure the reduction of new issues through direct support to the improvements to procedures, processes and tests methods and the corresponding training activities.
Expedited Risk-based Investigation Resolution and Reduction
Minerva provides on-site and virtual quality investigation teams combining multi-disciplinary capabilities and supported by development scientists, engineers, and visualization experts.
We diagnose and correct manufacturing issues as soon as, or before they occur; producing better corrective and preventive actions.
Quality Investigations
Since quality investigations play a critical role in maintaining the integrity and safely of your products -in the access of therapies to patients and in the assurance of regulatory requirements- Minerva Provides your company with an integrated approach to quickly respond, effectively resolve and permanently reduce your quality investigation.
This integrated approach is based on:
Our Multi-Disciplinary Team Approach:
Our team of investigators examine and analyze deviations, incidents, and issues that occur during the manufacturing, handling, or administration of advanced therapy products.
We identify the root causes of problems, determine their impact on product quality and patient safety, and implement corrective and preventive actions to prevent recurrence.
Key Aspects of a Quality Investigation in Cell Therapy Process Include:
Structured Impact Assessment
to evaluate the potential impact of the deviation on product quality, safety, efficacy, and regulatory compliance, as well as its potential implications in order to properly assess patient outcomes.
Digitalized Root Cause Analysis (RCA)
to conduct a thorough investigation to identify the underlying causes of the issue, which may involve reviewing manufacturing records, conducting interviews, performing laboratory tests, and analyzing process data.
Technically Supported Corrective and Preventive Actions (CAPA)
to avoid the likelihood of similar incidents in the future and strengthen the overall quality management system.
Standardized and Template-Based Documentation and Reporting
for investigation process, findings, conclusions, and actions in a comprehensive investigation report, which may be submitted to regulatory authorities as part of compliance requirements.
Risk-Based Solutions and Recommendations
to assess the risks associated with the deviation or incident and implementing risk mitigation measures in order to minimize potential harm to patients and ensure continued product quality and safety.
Regulatory Compliance Assured
We will ensure compliance with relevant regulatory requirements, guidelines, and standards governing the manufacturing, testing and administration of cell therapy products such as Good Manufacturing Practice (GMP) regulations and guidelines from regulatory agencies like the FDA or EMA.
We will proactively support you, enhancing the quality management system and strengthening confidence in the availability and quality of your cell therapy products.
Timeliness
is Joy.
Reduce your ATMPs investigation resolution backlog and improve your product delivery timeliness the Minerva Way.