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Manufacturing

Controlled manufacturing workflow

Manufacturing information is described as a process framework: raw materials, production, assembly, quality checks, packaging, storage and distribution.

Laboratory production workflow with pipetting and sample preparation
Operational Framework

From raw material to distribution

Capacity, equipment and facility claims are intentionally left out until verified documentation is available.

  1. 01

    Raw materials

    Supplier qualification, material specifications and incoming QC records.

  2. 02

    Production

    Documented batch processes, in-process checks and trained personnel.

  3. 03

    Assembly

    Controlled assembly steps for kit, device or assay components where applicable.

  4. 04

    Quality checks

    Inspection and release criteria defined by product documentation.

  5. 05

    Packaging

    Labeling, IFU placement and packaging controls aligned to requirements.

  6. 06

    Storage

    Temperature, shelf-life and inventory controls as specified.

  7. 07

    Distribution

    Dispatch and channel support with traceable records.