 Good Laboratory Practice
STARLIMS helps lab establish and maintain
Good Laboratory Practice (GLP) documentation procedures for
closed-loop traceability and
regulatory compliance. Among other
functions, STARLIMS facilitates maintaining versions of test
methods, training certifications for analysts, logbooks for
instruments and standards, control charts, MSDS and more.
The Materials Manager maintains the inventory
of standards, reagents, containers and other materials used in
the sampling and testing processes. In addition, the system
provides tabs to maintain additional information such as links
to MSDS, material recipes, etc.
The Instrument Management Module helps ensure
regular ongoing maintenance, by establishing schedules, tracking
completed tasks (including real-time annotations on actions
taken) and flagging incomplete tasks. Depending on lab-specific
configurations, certain requests may be disabled until the
required maintenance task is completed.
STARLIMS ensures the highest standards of
integrity and quality, in conformity with GAMP, ISO 17025, GLP,
EN requirements for audit trails, security, data integrity and
data archiving. This includes customer compliance with 21 CFR
Part 11 requirements for electronic records and signatures.
Good Laboratory Practice Security
STARLIMS security configurations facilitate
good laboratory practice by allowing users
to determine the functions and content accessible for a given
role. For instance, the functions of analysts would typically
include entering results and performing peer approval. Using the
STARLIMS Role Design Wizard, system administrators rapidly
create multiple roles, and assign them to various users.
Likewise, access to content can also be
limited to specific groups and individuals within the
organization. For instance, members of the chromatography group
may only be able to view their own group’s data, but a lab
manager may access data from various groups.
The Dashboard Parts Manager provides tools to
configure different dashboards for different roles, so the
appropriate content is delivered according to each person’s job
description and organizational affiliation.
 Good Laboratory Practice:
Audit Trail
The automatic audit trail function records
all changes in the audit log, indicating the nature, user and
reason for the change. The system administrator can limit the
fields subject to the audit trail, and the conditions required
to implement changes.
Version Control
STARLIMS safeguards data integrity by
disallowing changes to critical information such as test plans,
specifications, test methods and other controlled procedures.
Critical information can only be modified by creating new
versions.
Good Laboratory Practice: Document Management
STARLIMS offers laboratory document management as well as scientific data management in a single platform that fully
complies with 21 CFR Part 11. STARLIMS Document Management
functions are fully integrated into the STARLIMS workflow, for
automatic simultaneous presentation of STARLIMS content and
captured documents enterprise-wide. Routed content and documents
may include SOPs, analyst certifications, electronic training
materials, investigation reports, captured instrument outputs,
COAs (Certificates of Analysis) generated by the laboratory for
users, scanned COAs received from suppliers, and more.
Altogether, STARLIMS provides scientists and
lab users the ability to securely store and share complete
scientific reports in various textual, graphic and audio visual
formats. This provides rich and complex data extraction during
data querying and analysis for good laboratory practice.
Multi-Lab Capabilities
As an Internet-based system,
STARLIMS V10
enables using a single database to run multiple laboratories
operating at different geographical sites. Access to data is
defined for each user. Some users may only view local data,
while management may access a wider view spanning multiple sites
and labs. Alongside these functions are capabilities that allow
for transfer of samples between labs to accommodate for
conditions such as capacity overflows, etc.
Add-On Modules
The stability studies module provides a
workflow for the creation, review and approval of stability
study protocols, which are converted to studies. It provides
reminders as to when samples need to be pulled from storage and
sent to testing. Built-in inventory management capabilities
provide real-time information about the stored samples, their
location and storage conditions. The reporting and analysis
module provides tools to extract stability data and perform
calculations (expected shelf life, etc.)
To Learn More about STARLIMS Good Laboratory
Practice, see also:
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