Quality Management Systems

In compliance with global regulatory quality system requirements, we tailor our services to meet individual needs while adhering to all legal obligations, including the following areas:

QMS

Minervate implement and monitor key milestones and policies within your company’s operations, ensuring the effective and efficient execution of Quality Management Systems. Through leadership-driven readiness initiatives, we guarantee your company remains fully prepared for Regulatory inspections.

  • Audits and Inspections
    Provide correct support to guarantee companies are inspection ready and in adherence to protocol.
  • Risk Management
    Using proactive strategies used can help to identify, assess and mitigate risks throughout the trial lifecycle. Minimizing operational disruptions.
  • Supplier Management
    Supervision of correct handling and distribution of materials. Managing performance and warranting correct compliance to data protection guidelines.
  • Equipment Management
    Perform risk assessments and support with inspection readiness, certifying that equipment is always up to standard, compliant and ready for use.
  • CAPA Management
    Identify and address anomalies and resolve them in a timely manner, adhering to applicable regulatory requirements and GxP guidelines. Providing GAP analysis to address discrepancies
  • Document Control
    Minervate will ensure that ALCOA principles are adopted into your companies Quality systems and in alignment with standards and changing regulations.
  • Change Management
    Assure smooth transitions, with minimal impact on timelines, budgets and quality. Keeping track of regulatory updates and protocol adjustments.
  • Training Management
    Aid with overseeing project timeline and establishing delivery in a timely manner. Emphasizing GxP Compliance and QMS implementation.
  • Deviations and NCs
    Support in identifying non-conformances, implementing corrective actions and designing measures to prevent future occurrences.
  • Complaint Management
    Provide prompt resolution and detailed documentation of complaints. Ensure efficient handling, whilst maintaining confidence and reputation of the company.