LB Quality Process
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Engineering and Industrial Processes

Projects, facilities, flows and manufacturing processes designed around regulatory requirements and real operating conditions.

Illustrative editorial image: Engineering and Industrial Processes
Our approach

Facilities designed
for real operations.

Engineering assessment must consider both facility design and its operation. We bring together technical requirements, personnel and material flows, utilities and process controls with the practical feasibility of implementation.

Technical scope

How we can help.

Projects and infrastructure

  • Technical review of industrial projects against applicable health requirements
  • Review of descriptive and functional documentation for regulatory submission, including LTA when appropriate
  • Design and improvement of personnel, material and manufacturing flows
  • Technical support for commissioning, expansion and startup of facilities
  • Technical assessment of cleanrooms, equipment, utilities and support systems

Operations and performance

  • Mapping industrial processes and their critical attributes
  • Assessment and management of processes and projects
  • Execution of facility qualification and technical oversight of qualification for critical systems, within the agreed scope
  • Assessment of performance indicators and operational monitoring

Regulatory interfaces

  • Support for facility and project authorizations with competent authorities
  • Technical preparation for inspections related to facilities and processes
  • Guidance on applicable licensing and Good Practice requirements for each operation

Services depend on the applicable regulatory framework and the agreed scope. Certificates and official approvals, where relevant, can only be issued by the competent authorities or accredited bodies.

Explore more

Related services.

QUALITY

Quality Management System (QMS)

REGULATORY AFFAIRS

Regulatory Intelligence and Affairs

QUALITY + PROCESSES

Qualification and Validation

Shall we review your situation?

Describing your technical need is the first step in identifying requirements, priorities and scope.

Talk to LB Quality Process