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- ERP + Quality for Pharma
- Process
- Testing and exceptions
Testing and exceptions
Record a test outcome and carry an exception into batch investigation.
Step by step
-
Specification selection QC Analyst
QC Analyst identifies the product requirement and its test parameter, acceptance criteria, limits and effective date.
- Identifies the expected result for the product
- Updates Products, Quality specifications
-
Result entry QC Analyst
QC Analyst records the batch, test date, result value or text, instrument and analyst note.
- Records the observation on the right lot
- Updates Test results, Batches
-
Outcome review QC Analyst
QC Analyst classifies the result as Pass, Fail, Pass With Deviation, Invalid or Pending.
- Classifies the test outcome
- Updates Test results
-
Deviation review QA Manager
QA Manager opens a deviation against the affected batch if the result needs investigation, then records severity and the emerging root cause.
- Tracks the investigation and any affected asset
- Updates Deviations, Batches, Equipment
-
Batch decision preparation QA Manager
QA Manager reviews the result and investigation alongside other lot evidence before quality approval.
- Puts the evidence before the quality reviewer
- Updates Batches, Test results, Deviations
ApprovalA person approves before the work moves on.
Who does what
Roles and permissions- QC Analyst
- Records test results.
- QA Manager
- Investigates exceptions and prepares the quality review.
- Admin
- Maintains specifications.
- Production Manager
- Identifies the batch under test.
Set up ERP + Quality for Pharma your way.
Start free, then use Proto to change fields, steps and approvals before your team goes live.