Introduction
This user manual describes how to use LabHQ effectively to process samples for laboratory testing. LabHQ LIMS is an information management system, which allows data associated with material testing to be created, entered, processed and stored for reporting, typically via a Certificate of Analysis document. The system operates via the internet to afford remote access for example, by clients of a remote independent laboratory, or manufacturing staff at another site.
LabHQ has two user interfaces; the LabHQ Application is a Windows PC based component used by the laboratory to process samples. The web browser-based LabHQ Web Client is a second interface offering functionality for user to submit samples, view sample progress and access reports. Where the laboratory is a contract operations, the web client could also be used by clients of the laboratory.
As the sample lifecycle could involve the analysis of regulated pharmaceutical products, this system could be designated as a GMP-critical application. With this in mind, it has been designed to meet international Good Manufacturing Practice (GMP) regulations, as well as those concerning regulated electronic records and signatures (RERS).
The Sample Hierarchy
The Sample Life Cycle
External to the system, samples are sent to the lab. When the physical sample arrives, Jobs and Samples within the study are received within LabHQ by the laboratory. Test Methods can be added or removed from the samples at registration before a workbook is created. Workbooks are created by selecting a set of sample tests and assigning an associated analyst. Analysts can then enter results, automatically completing calculations and checking against product specifications. Results maybe entered directly into LabHQ from equipment readings or data recorded on hard-copy workbooks printed from LabHQ. Validation of results is carried out (by someone independent of the user who entered the results), and the results may then be approved. The client user will be able to access the Certificate via the LabHQ Web Client as soon as the results have been approved, which can be viewed on the screen and printed.
Where all samples have been approved, the Job and the Study will automatically take on the status of approved. Once a Study is approved, Jobs and Samples cannot be added or edited.
There is a provision in the system to start an investigation on a sample test method because a result is out of specification or the validator finds an issue with the test results. A comment can be entered, which may reference an external process for completing an investigation, and a flag on the sample test method will appear. Before the results can be approved, the investigation must be stopped to ensure all outstanding activities are completed before the results are available to the client user.
Users gain access to the LabHQ Application and the LabHQ Web Client by logging on, where they must correctly enter their personal User Name and password. Multiple incorrect attempts at log in results in the user’s account being locked by the system. User accounts are used to configure specific permissions for each system function, to allow actions to be restricted to those necessary for the user to perform their role in LabHQ.
At key points in the default sample life cycle there is an option to send e-mail/alert notifications to other LabHQ users, as an additional communication mechanism that some event has occurred. Such notifications can be sent at Job submission, Sample receipt, Sample registration, Sample approved and Job document added. These notification events can be configured for each user as part of the User Account set-up. All e-mail services are operated independently by LabHQ and do not require the use of existing e-mail applications for sending the notifications.
LabHQ Infrastructure
The specifications for PCs and laptops to operate LabHQ Application are:If there is a history or known likelihood of internet disruptions at your facility it is suggested that having a backup means of accessing the internet for operating LabHQ is considered, such as a mobile broadband dongle from a mobile network provider, providing the facility has sufficient signal strength.
- Operating System – Microsoft Windows Vista/7/8/10 machine
- Internet Connection (Recommend broadband speeds of 100kbps/user)
- Minimum 1GB RAM memory
- Minimum 1024 x 768 (XGA) Monitor resolution
Note: LabHQ Application is not designed to operate on Apple computers or operating systems for portable devices, such as Android
The specifications for PCs and laptops to operate LabHQ Web Client are:
- Operating System – Microsoft Windows Vista/7/8/10 machine*
- Web browser: Google Chrome version 48 or later, Mozilla Firefox version 44 or later, Microsoft Internet Explorer 9 or later*
- Application to view PDF documents (e.g. Adobe Acrobat Reader)
- A minimum processor equivalent of a 1GHz Pentium IV is recommended with 512MByte RAM.
- Minimum 1024 x 768 (XGA)Monitor Resolution
- Minimum 256 kilo bit Broadband connection
* Other operating systems (e.g. Android) and web browsers (e.g. Safari) may operate LabHQ Web Client successfully, but these have not currently been tested by the system supplier so correct operation is not guaranteed.
Insert Figure 1-3: LabHQ Communication Structure
The system prints reports on standard monochrome or color printers that have drivers for the above Microsoft Windows operating systems, connected either locally or via a wireless/cabled networked.
Any organization using LabHQ must ensure that suitable PC anti-virus software and/or network firewalls are installed, operable and are updated to ensure that the LabHQ system and data integrity is maintained.
Other Considerations before using LabHQ
- There is a regulatory expectation that all users will have appropriate training for their use of the system, and this should be documented. This is the responsibility of the laboratory who operates the system for their samples.
- The system can be configured to utilise electronic signatures for key actions. All users must be aware that the e-signature is the legally binding equivalent of their handwritten signature. It is recommended that each user must agree to this in writing, for example by signing a declaration on the form completed when setting up their user account.
- In order to aid compliance with electronic record regulations, the system records key actions for system access, sample and test data in an audit trail, which records who did what, their set role, when, what changed and the reason for doing so, where appropriate. This implies that the system must be able to identify each user. This occurs by the system recording the User Name, entered at login, for each action. It is therefore critical that each user account is traceable to an individual user, which means that:
a) The User Name must be linked to the recognisable full name of the user (used when printing reports).
b) It is therefore not permitted to have generic logon accounts that may be used by more than one user.
c) As a condition of use, each user is responsible for keeping their logon password confidential.
It is highly recommended that these points are included in the training of each user.
- The exception to point b) above is the default account created when the LabHQ instance is created. As part of the initial system configuration, once specific User Accounts are created, at least one of which has permission to edit User Account information, the default account must either be locked or permissions be restricted to only those functions in LabHQ which do not modify critical data.
User Interface Conventions
- The header contains function access tools such as menu items and page title
- The main body
- And the footer generally contains function specific action buttons and navigation buttons
- Menu available to the user based on permissions
- Logged-in user information
- Lifecycle icons displayed based on user permissions
- Page title
- Searchable left-hand pane. Items selected in this pane dictate the data displayed on the right.
- Buttons to complete the current function, such as Cancel, Save, Receive, etc.
Questions, warnings and confirmations are typically displayed as pop-up dialog windows, which are conventionally navigated using [Yes], [No], [OK] or [Cancel] buttons.
LabHQ Reports
By default, the system does not apply any security to the pdf reports as it is anticipated that these will be mostly printed immediately. If you require these features in order to save or e-mail the pdf, then you will need to install Adobe Acrobat or a similar pdf reader application which can then be set up as your default pdf reader, while also providing these features.
There are two reports within the LabHQ lifecycle which do not open in pdf prior to printing. These reports are the sample labels generated at receipt and workbooks. This feature ensures users of the system cannot retain the report by saving as a file as a means to record all printing and re-printing actions in an audit trail.
Many reports also give the option to alternatively export the report data into a file format that can be opened in Microsoft Excel. This may be useful if there is a need to use the data in another document or perform further analysis or processing of the data. Depending on the report, it may be necessary to filter out or remove page header and footer information from the exported data before processing and formatting can be performed.
Note that once report data has been exported it is no longer controlled by LabHQ security features, so data integrity is not guaranteed and must be manually controlled as required.