Fast response, resolution, and reduction
of technical and quality issues
the Minerva Way
Minerva provides on-site and virtual quality investigation teams of multidisciplinary experts
—including development scientists, engineers, and visualization specialists—to address quality and technical investigations across the life sciences industry.
Minerva’s R3 quality investigations provide comprehensive solutions to all your process and quality investigation needs, ensuring optimal outcomes while avoiding recurrence of issues.
The C3 technical investigations scientifically support the R3 investigations, or act as a standalone service, to strengthen product development and improvement.
Minerva addresses and prevents a wide array of issues through controls based on knowledge and quality risks. This results in the reduction of investigation needs and the elimination of investigation backlogs.
We execute technical and quality investigations of issues in manufacturing areas, laboratories, quality assurance, quality control, and supply chain. This integrated approach ensures the sources of issues are addressed at the same time, using integrated CAPAs.
Minerva’s multidisciplinary team uses database collaboration and planning tools to facilitate issue classification and the aligned initiation of investigations, using agreed-upon hypotheses and investigation templates.
We use structured digital tools to quickly and accurately evaluate the potential impact of deviations on product quality, safety, efficacy, and regulatory compliance. The digital impact data is used for statistical analysis to quickly establish the proper investigation approach.
To optimize efficiency and accelerate turnaround times, we employ investigation templates investigation and use private machine learning (ML) to swiftly integrate data and text into initial drafts. The initial draft is verified and corrected before a pre-aligned review process takes place, supported by the Minerva team.
Minerva uses a combination of knowledge management (KM) and quality risk management (QRM) to strengthen the product quality system (PQS) as a result of the investigation resolution work. Our integrated visual-digital approach to root cause analysis results in better controls to prevent issue recurrence.
We continuously reduce issues with systematic root-cause analyses using fully digital 5 Whys, cause and effect fishbones, fault tree, and FMEAs, determining the most probable causes with ease and precision.
In addition to our desktop analysis by engineers and quality experts, our scientists perform laboratory experiments to identify deeper root causes, creating corrective and preventive actions (CAPAs) to avoid issue recurrence and strengthen your quality management system.
Historical and new digital risk records resulting from the investigation process are added to the risk file as real time references for new failure mode analyses (FMEAs). This applies to failures from process (pFMEAs), design (dFMEAs), and usage (uFMEAs).
Through method improvements, visual training material, and facilitation of on-the-job training, Minerva helps you address the root causes of human errors.
the Minerva way
