Services

By providing external expertise of Quality Assurance, System and Process Validation, Risk -Awareness and -Management, quality problems can be solved, stagnant processes mobilized, and uncertainties about compliancy eliminated.

                                                    QVRAM Offers
Quality assurance, system Validation, Risk -Awareness and -Management

Audits and Assessments
>  3rd Party Audits: Review external service provider and suppliers (CROs, Laboratories, 
          IT-Application-, System- provider, Logistic
>  Internal-Audit: a fresh perspective of internal processes
>  Mock-Audit:    as basis for audit/inspection-readiness
>  Project and Process Review: basis for optimizing Quality and decision making
>  Quality assessment of planed processes: for risk minimizing and quality assurance.


QMS Quality Management System; small companies (Human-health areas);
>  Accompanying upgrades and new implementation: Basics, training and implementation or
       (new) assessment, in consideration of the state, health and local law, ISO90012015, as well
       as the QVRAM methods “SW5Par” und “Work SMARTER”


CAPA (corrective and preventative action)
>  Creating CAPA management plans based on audit or inspection reports: to prove the fulfilling
       of correcting actions and avoidance of reappearing of the issues


Workshops, Training, Education
>  ISO9001:2015              :  Basics, Transition, Internal-Auditing, Audits
>  Process management  I:  documentation and SOP writing
>  Process management II:  Analysis, maintenance, improving of processes
>  Quality assurance        I:  QMS – Basics and implementation
>  Quality assurance       II:  Continuous improvement and risk awareness
>  Risk management       I:  Basics and Quality risk management
>  Custom-engineered In-House education and training
>  GCP, clinical trial management, important steps, critical path, must and should haves

QVRAM  approach to work

Goal
·   Without a measurable aim there is no beginning (nor an end)

Tools
·   Work SMARTER
      The QVRAM-Method is based on:

          S          specific
          M         measurable
          A          acceptable
          R          risk awareness
          T          timely
          E          effective
          R          reflective

·   Principles
     o  Nothing in the entire universe can be considered independently
     o  The only measure for quality are the requirements
     o  Cooperate with everything attached to the issue. Wrestle with the problem and we all lose
     o  Without a theory – no questions
     o  Without a plan – no deviations


·  Knowledge
     o  System thinking and wide networks
     o  A wide experience within Health and Pharma areas


Borders
·    All QVRAM assignments will have a time limit.

Conditions
-   QVRAM works together with the client;
    pragmatic according to the principles and methods;
    organised and documented, and
    strictly confidential.