Part 2 will cover Automation of Crucial QA/QC Processes and Support of QbD and Data Integrity.

Automation of Crucial QA/QC Processes

Users can configure STARLIMS to automate most of the QA/QC laboratory’s crucial processes. Along with retests, the solution can generate calculations, workflows, reminders, alerts, and retests. STARLIMS can also automate calibration, schedule environmental and stability samples, and issue purchase requests when inventory is low.

STARLIMS can also sample outsourcing, enabling labs to swiftly identify samples that are required to be send out to third parties. Personnel can also track samples to ensure the punctual completion of tests.  

QA/QC laboratories are required to manage outsourced analytical workflows with as much diligence as operations within their facilities. Bidirectional data traffic to and from a lab will eliminate mistake-prone stages involving manual data entry. Thus, partners are required to operate with secure data management, allowing two-way flow of digital data that is fully traceable.

Support of QbD and Data Integrity

Supporting assurance of end-to-end assurance of data integrity through traceability of processes associated with sample or batch, STARLIMS also provides secure sample management tools, instrument integration, electronic signatures, chain of custody, and audit trails. As a result, the probability of human error and unauthorized data revisions are significantly decreased.

STARLIMS is a smart platform that enables QbD from the beginning stages of development to the last step of manufacturing. QA/QC lab personnel are able to anticipate and prevent impacts on product consistency through regular reviews of process controls and trending data provided by STARLIMS.

A configuration that combines LIMS to an SDMS (scientific data management system) and an ELN (electronic laboratory notebook) will further decrease errors resulting from manually entered data. Moreover, it will promote adherence to SOPs (standard operating procedures). The distinct advantage of STARLIMS is that it comes as a completely integrated solution, providing SDMS, ELN, Advanced Analytics, and Mobile features. This avoids integration headaches resulting from a mix of software from various third-party vendors.

Part 3 will cover Holistic Solution Advantages and ALCOA Effect.

Alpha LIMS Implementation

Alpha has been involved with the implementation of over 50 LIMS systems ranging in size from small, “off-the-shelf” software systems to very large, highly customized, multi-functional systems, including STARLIMS, for both governmental agencies and private enterprises. For affordable client-focused network consulting services and solutions, please call Alpha today at (410) 295-9500.