Laboratory Concepts: Master Data Management

 

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Fundamental Concepts

 
              

 

Fundamental Concepts

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Laboratory Concept LabVantage Concept Example
Versioning A Version defines the status of an entity that is version-enabled. Versioned-enabled entities include (but are not limited to) Products, Parameter Lists, Specifications, and Test Methods. Note that Versions are defined at the object level (not the instance level), e.g., Parameter Lists rather than Data Sets, Test Methods rather than Tests, and so on.

Version Status can be Provisional (a draft Version in the process of being revised), Current (a Provisional Version that has been Approved), Active (a previously Approved Version that can still be used but has been superseded by a newer Approved Version), or Expired (no longer usable).

 I must conduct a test on a Sample. This test is very similar to an existing test that is already defined. I therefore create a new ("Provisional") Version of the existing method upon which this test is based. I modify this new Version of the test as required, then I have this Version Approved. The Approved Version becomes the "Current" version.

Further along during the testing cycle, changes must be made to the test. My colleague therefore creates a new Version based on my "Provisional" Version 1, then has this Version Approved. This now becomes the "Current" version, and the test I modified becomes an "Active" version.
Effective Date The date specified within the system for an entity when a it becomes effective for use. Specifically for regulated industry the effective date for an entity should be a date after it is approved. A Specification is approved on July 10, 2015, and made effective for use starting July 13, 2015.
Data Approval During Data Entry, Approval Types specify rules for approving Data Sets. An Approval Type is associated with a Approval Steps and Parameter List. The rules therefore apply to all instances of the Parameter List (Data Sets).

In order to conduct Approval on a Data Set, a User must be listed in an Approval Step, with the necessary permission as Approver, conforming to basic Approval rules.

During Data Entry, an Approval Step can Approve a Data Set after all Data Items in a Data Set have been Released.

After all Data Sets associated with a Sample have been Approved, the Sample is ready for Review. Review allows authorized personnel determine the Disposition of the Sample (such as Approved or Rejected).

 My procedures stipulate that during Data Entry, a different User must conduct each Approval, the data can pass the Approval process only when all Approvals have passed, and the Users in the Approval process must belong to the "Lab Manager" Role. I therefore create Approval Steps and an Approval Type to define these rules.

During Data Entry, each Approver defined by the Approval Step evaluates each Data Set as "Pass", "Fail", or "Pending Action".
Template A Template is used to predefine every attribute about a Sample or test to run.