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A collection of records in LIMS corresponding to an inspection, initiated by a Quality Assurance QA inspector
Define Batch Initiation
The process by which QA Inpsectors, or their designee, create a batch and associated samples into LIMS
The primary GUI (Graphical User Interface) to LIMS
Define LIMS. What does L I M S stand for?
- The StarLIMS Laboratory Information Management system deployed at our company.
- L = Laboratory
- I = Information
- M = Management
- S = System
Information that is entered to describe a batch, sample, or test (depending upon the context)
Define Batch Disposition
The process by which QA(Quality Assurance) makes a final usage decision for a material in LIMS.
A collection of samples, logically associated in LIMS. Samples may be composited if they have the identical lot information and testing requirements
Define Sample in LIMS
A logical representation in LIMS of a physical quantity of an inspection material. Individual samples of inspection material are distinguished by their sample number.
Define sample Receipt in LIMS
The process by shich a sample is acknowledged to be present in the testing laboratory. The sample receipt process in LIMS updates the status of the sample from "SendToLab" to "Received"
Define result in LIMS
A logical representation in LIMS of an individual component of test, corresponding to an observation.
Define Test in LIMS
A logical representation in LIMS of a collection of data entered into LIMS for the measurement of a specific property or series of properties of a sample
Define the Responsibilities of the QA inspectors for LIMS
1) collect samples from each line per manufacturing specifications.
2)Initiating a batch and logging samples into LIMS for each lot of samples collected
3) Ensuring that each printed LIMS lable is accurate to the item number and lot placed on the corresponding samples
What are the Analyst responsibilities?
Recieves and composites samples and enters the test results in LIMS
What are the Lab Managers responsibilities?
Or desinee, recieves and composites samples in LIMS
What are the LIMS administrator's responsibilities?
Ensures that the system is in a state of change control which matches the configuaration SOP. Supplies training to new users. Reviews and approves system changes.
What two things initiate a batch in LIMS?
- 1. Finished Goods inspection
- 2. Raw Materials Inspection
List the LIMS sample life cycle
- 1. Finished Goods or Raw Material inspection
- (Batch Initiation)
- 2. Sample receipt
- 3 Result entry and scheduled sample initiation
- 4. Test Review
- 5. Sample review
- 6. Batch Disposition
Define Run in LIMS
A group of samples to be tested simultaneously for the same/similar analytes
Define the responsibilies of Quality Assurance
Initiates samples in LIMS and delivers samples to the appropriate parties, reviews the totality of the data available for a batch, and assigns a usage decision to each batch in LIMS based upon that review.
A retest of an existing lot starts at which batch life cycle
c)Initiation of batch
Restest of an existing lot start at the initiation of batch phase under the create batch tab and select login method drop down box.