QUALITY MANAGEMENT eCOMPLIANCE, VALIDATION AND QUALIFICATION

The goal of absolute avoidance of post manufacturing controls and re-work.

Quality within the regulated industry is an essential element for business success and improvement. Therefore, our focus is to ensure that your systems are working efficiently and your quality requirements are fulfilled to deliver right products at right time.
The regulated industry is a world of its own.
We make it our business to know and understand this world and its challenges down to the last detail including the regulations that govern it.

prime4services offers top-in-class consulting and engineering services worldwide, enabling our customers in regulated industries to choose and apply process supporting systems without being tied to any one provider. We do this with the help of method-based concepts that embrace processes, technologies and people.

prime4services emphasis is on the processes and the people operating those processes day in, day out, and their full capabilities, alongside the technology, thus laying the foundation for a much more structured and focused implementation approach and optimized operational usage.

Our typical service range encompasses the following (not limited to):

  • Project and programme management
  • Project engineering services:
    • Functional system design support
    • Interface design support
    • Infrastructure design support
    • System configuration
    • Technical administrator training
    • Technical test support (IQ & OQ)
  • Quality Management and Validation services:
    • Validation management (outsourced)
    • Creation of test documentation (IQ to PQ)
    • Creation of SOPs (technical and business)
    • Test execution support
  • Business Change Support services:
    • Business Change process management (outsourced)
    • Creation of role-based training concepts & related training material
    • Training execution
    • Business test support (PQ)
    • Start-up and post go-live support services

With prime4services the scope of a project stretches beyond the project horizon and ensures that the benefits realized are sustainable beyond the project lifecycle. Besides a very structured and tailored life cycle management we also support our customers with continuous activities such as training and / or system support. We support our customer in getting prepared to efficiently operate highly automated and integrated manufacturing processes by providing the following ranges of services:

  • Lifecycle management concept development including corporate standards
  • Best fit support model development
  • Staff training, Train-the-Trainer, training concepts
  • On-going system auditing processes (performance, usage & support cost optimization)
  • Mid- / long-term migration concept development
  • System migration planning & execution (technical and business)
  • Deviation and CAPA support