QMS Implementation: Ensure Compliance & Operational Efficiency

Scenario

A new aseptic manufacturing facility in MENA required a QMS to support its operational start-up. With the project in fast-track mode, the client needed ready-to-use SOPs, templates, work instructions, and forms that could be quickly adapted to their specific context.

Strategy

Assessment of the global context and planning integration.
Road map definition (Scope, Phase 1, Phase 2, Phase 3).
Team establishment (PM, SME, operational).
Governance definition.
KPIs definition implementation.

Outcome

Phase 1: Core QA processes establishment.

Phase 2: Establishment of QMS documents (SOPs, WI, forms, etc).

Phase 3: Coaching and ad-hoc expertise.

Weekly progress meetings, monthly steercos.

Read Case Study

Efficient QMS implementation also streamlines clinical data management. Explore our insights on streamlining patient profiles.