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LIMS tour5 steps · about 2 minutes

From sample to approved result

See how a finished-product sample, its results, an OOS investigation, instruments and stability studies are controlled in the QC lab.

Start the tour Pharma LIMS
  1. QC sample MS/2026/00054 linked to its batch, with seven assigned tests all completed and approved

    Step 1 of 57 tests approved

    One sample, every test reviewed

    MS/2026/00054 is a finished-product sample with seven tests. The sample is complete only when every test result has been reviewed and approved.

    1. Linked to its batch
    2. Second-person review
    3. Each test tracked
  2. Assay test result of 99.4 evaluated within the specification limit of 95 to 105, with original flag and entry time

    Step 2 of 5Within limits

    Results checked against the limit

    The assay result is evaluated against its specification limit as it is entered. A correction never overwrites: the original value stays on record.

    1. Specification limit
    2. Evaluated on entry
    3. Corrections keep the original
  3. OOS investigation record with the failing result, impact assessment and level 1 investigation reviewed and approved

    Step 3 of 5Finalised & locked

    Out of specification, investigated and locked

    An assay of 93.1 % against 95.0–105.0 % opened OOS/2026/0001. The phase I investigation is reviewed by the QC manager and approved by Head QA, then the record is finalised and locked.

    1. Finalised & locked
    2. The result and its limit
    3. Reviewed and approved
  4. Instrument record for a platform balance with maintenance and calibration schedule and qualified-for-use status

    Step 4 of 5Qualified

    Instruments qualified before use

    Each instrument carries its maintenance and calibration schedule and its qualification status. A balance that is not calibrated cannot be used at dispensing.

    1. Calibration due soon
    2. Qualified for use
    3. Critical instrument
  5. Stability study STB/0001 with product, batch, pull schedule, storage condition and approval

    Step 5 of 5Protocol approved

    Stability studies on schedule

    STB/0001 is a 36-month long-term study with its pull schedule and reserved samples. The protocol was reviewed by the QC manager and approved by Head QA.

    1. Next pull date
    2. Approved, with name and time
    3. Trend & shelf-life

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