© 2018 by STEP-IN Management Ltd.

STEP-IN Management also offers:

 

Audits:

  • GMP and GCP

  • Formal audits pre submission; pre inspection or part of your annual audit plan

  • Less formal 'sanity checks' to assess if you are on target and to provide insights

Quality Management Systems

  • Establishing small-scale, pragmatic QMS for start-ups

  • Proportionate QMS that can grow with size of the operation

Outsourcing transition:

  • Quality Management Plans to set out minimum standards for the management and monitoring of quality activities during transition to steady state

  • Reflects and complements contract, work orders and KPIs

  • Allows for practical, risk -based, interim processes while the workflow and relationship matures

  • Quality Check Plans to document and monitor expectations of both sponsor and supplier parties regarding processes and behaviours.  Early data supports open discussion so helping issues to be nipped in the bud and unhelpful behaviours to be addressed

  • Data-driven remediation of allows for open discussion and