LabHQ Terminology Guide
Archive
The process of marking data in LabHQ as no longer active while still retaining the data for future reference and reinstating where required.
Attachment
A document or file that is uploaded to LabHQ and linked to a specific job or sample as supporting information.
Audit
A record of all actions, creations, modifications and deletions made in LabHQ, including user responsible, data created or changed, along with date and time stamp.
Batch Number
An identifier assigned to a group of samples which have been manufactured as the same product under the same conditions.
Client
An individual or organization that requests testing services from your organization.
Clone
The process of creating a new static data object, such as a test method or test suite, using the same configuration as an existing object but under a new name.
CSV / Comma Separated Values
A file format used to capture and present tabular data, where each line corresponds to a row and each value is separated by a comma. CSV is a commonly used format for storing tabular data and is widely used to facilitate import and export of data.
Custom Field
A user-defined field that allows capture of additional information specifically tailored to the organization’s processes or requirements, enabling the addition of new fields not included in the standard configuration of the lifecycle.
Draft
Refers to static data objects, such as test methods or products, where the setup is not yet complete, or the items are still under review and have not yet been approved for use in the LabHQ lifecycle.
Dynamic Data
Data that is generated within the sample lifecycle.
E-signature
A digital method of signing or approving actions or data within LabHQ, allowing the user to authenticate their identity in compliance with regulatory standards such as 21 CFR Part 11.
Export
The process of extracting data from LabHQ, such as test results and sample information. A data export is typically in the form of a CSV file. The data export may then be used to import to an external tool or for integration with another system.
GxP
A collective term for good practice standards in specific environments concerned with regulations for development and manufacturing of pharmaceuticals and other related industries.
Import
The process of pulling external data into LabHQ from another system or file, such as legacy result data for trending.
Investigation
The process initiated in LabHQ following a sample failure or non-conformance to conduct root cause analysis and resolve any issues.
Job
A group of samples to be processed together in LabHQ. The group of samples may be for a single product or for multiple products that need to are to be sent to the laboratory for analysis at the same time.
Job Certificate
Otherwise known as a Certificate of Analysis. A printable report generated by LabHQ to summarize the results performed across all samples within a job, including sample and test information, whether or not each test meets the assigned specification and electronic signatures for verification and approval.
Job Submission Summary
A report generated by LabHQ after a job has been submitted. It contains all of the job details a list of samples submitted as part of the job.
List
A set of user-defined values that can be used to standardize recording of data in the lifecycle, including custom field entries and test method inputs.
MFA / Multi Factor Authentication
Requires a user to provide more than one verification factor to access LabHQ, including both password and a second form of authentication, such as a verification code from an email or authentication app.
OOS / Out of Specification
Refers to a result that falls outside the specification limits for a product.
OOT / Out of Trend
Refers to a result that falls outside the trend limits for a product.
Organization
The name of a LabHQ environment for a specific company which is independently managed with securely isolated user accounts, data and resources, ensuring complete separation and privacy from others.
Permission
An access right assigned to a user account that controls what actions or functions the user account can perform or access within LabHQ.
Product
A manufactured item or material that is tested within the laboratory, including finished products, raw materials or inventory.
Publish
The process of approving static data objects for use in the LabHQ lifecycle, moving them from a ‘draft’ state to a ‘published’ state.
RERS
Regulated Electronic Records & Signatures specific regulations related to the control of critical computerized records and electronic signatures. Also known as ER/ES or 21 CFR Part 11 (specific US regulations).
Report
A document generated by LabHQ that outputs data from the system in a pre-defined format. Reports include LabHQ generated documents, such as certificates and workbooks.
Report Template
A pre-defined format that LabHQ follows to generate its reports consistently. This includes the standard report templates provided with LabHQ and any customized report templates uploaded by the organization.
Reason for Change
A documented justification for a modification in LabHQ, requested on saving and captured in the audit.
Result
The output(s) of a test performed on a sample.
Sample
A small amount of material or product taken for analysis.
Sample Certificate
Otherwise known as a Certificate of Analysis. A printable report generated by LabHQ to summarize the results performed on a specific sample, including sample and test information, whether or not each test meets the assigned specification and electronic signatures for verification and approval.
Sample Label
A printable label that can be physically attached to a sample, allowing the sample to be traced during it’s time in the laboratory. The label contains the Sample ID, batch number and product information.
Specification
A pre-defined set of criteria detailing the expected characteristics and tolerance limits for a product to ensure consistency and compliance in testing.
Test
A test method performed on a specific sample in LabHQ.
Test Method
A procedure in LabHQ that defines all of the parameters (test method inputs) to be performed on samples and the results (test method outputs) to be generated from performing the test.
Test Method Input
The parameters required to be performed on a sample during testing. These could include values required for calculations.
Test Method Output
The results to be generated after performing a test on a sample. These could include the final result derived from a calculation using one or more test method inputs.
Test Suite
A group of test methods in LabHQ typically required to be performed on a product together.
Trend
A graphical representation of the results for a specific product and test method over a given time period in LabHQ.
Test Suite
A test suite is a group of test methods typically carried out together. Test suites are assigned to products to aid with job submission. Test suites are independent and can therefore be used across multiple products.
Units
Refers to the units of measurement when quantifying test results in LabHQ. These might include units of measure for mass (g, kg), volume (ml, l), concentration (mg/l, ppm), temperature (Celsius, Fahrenheit) or time (seconds, minutes).
User Account
A unique profile related to each individual granted access to LabHQ. A user account allows users to log in to LabHQ, access certain features or functionality through permission control and access certain data through client access.
Versioning
Version control in the LabHQ application helps preserve data integrity. Version control works by creating a modifiable new version of a data object rather than allowing the original to be modified. Version control in LabHQ applies to test methods and products.
Workbook
A printable report generated by LabHQ for recording test results for a limited number of jobs/samples which can be transferred to LabHQ following completion of testing. The workbook serves as a hard copy of test data for record keeping and regulatory purposes, where the documentation may be required as part of an inspection.