It is imperative for Life Sciences companies to move from the typical decentralized Global Validation Governance to a centralized strategy as pressures mount on the competitive landscape.

DECENTRALIZED GLOBAL VALIDATION

  • Organization for (SQA, Leads, Managers) CSV resources is structured within different reporting structures
  • Requires following multiple processes depending on business unit
  • Requires staff to train on multiple processes
  • Difficult to improve processes
  • Managing multiple processes creates overhead and risk
  • Increases planning effort
  • Inconsistent approach across organization may increase risk

CENTRALIZED GLOBAL VALIDATION

  • Organization for (SQA, Leads, Managers) CSV resources is within the same reporting structure
  • Follow a single process across the organization
  • Increases feedback loops for process optimization
  • Allows systematic approach to be implemented which is consistent
  • Reduces effort for planning of validation
  • Increases communication
  • Consistent approach across organization mitigates compliance risk

Our Goals

http://www.engisystems.com/wp-content/themes/salient/css/fonts/svg/basic_globe.svg

Manage and navigate the global regulatory compliance landscape

http://www.engisystems.com/wp-content/themes/salient/css/fonts/svg/ecommerce_dollar.svg

Reduce overall costs

http://www.engisystems.com/wp-content/themes/salient/css/fonts/svg/ecommerce_graph_increase.svg

Increase efficiency and utilization factors

http://www.engisystems.com/wp-content/themes/salient/css/fonts/svg/ecommerce_graph3.svg

Maintain compliance and sustainability

http://www.engisystems.com/wp-content/themes/salient/css/fonts/svg/basic_elaboration_bookmark_checck.svg

Manage and utilize software validation best practices