As discussed in Part 1, the FDA and EMA have tasked pharmaceutical companies to determine the basis of a QbD (Quality by Design) approach for their product life cycles.
Part 2 will discuss Automation of Critical Processes, Data Integrity, and Holistic Solution.

Automation of Critical Processes

Configurable in order to automate most QA/QC laboratory’s crucial processes, STARLIMS generates workflows, calculations, calibration, alerts, reminders, trigger resets, and reports. Similarly, environmental and stability sample scheduling and purchase requests for inventory stocks can be automated.
QA/QC labs must also ensure that third-party analytical workflows are overseen as diligently as on-premise operations. Fully integrated bidirectional data traffic to and from a QA/QC laboratory eliminates mistake-prone manual data entries.

Data Integrity

STARLIMS helps ensure data integrity via traceability of processes, secure sample management, audit trails in compliance with 21 CFR Part 11, electronic signatures, instrument integration, and chain of custody. As a result, the probability of human error and unauthorized data revisions are greatly decreased, making data traceable, secure, and trustworthy. Supporting QbD, STARLIMS allows QA/QC laboratory staff to be proactive in the prevention of product inconsistencies through process control reviews and trending charts generated by the platform that detect harmful variations or anomalies.
Integrating a LIMS with SDMS (scientific data management system) and ELN (electronic laboratory notebook) capabilities decreases mistakes resulting from manual data transfer during SOPs (standard operating procedures). ELN enables front end electronic orchestration and back end recording of workflows and processes. Full integration by STARLIMS of LIMS, SDMS, and ELN features eliminates third-party vendor configurations and reduces TOC (total cost of ownership).

Holistic Solution

STARLIMS offers a unifying holistic solution that decreases the chance of additions becoming faulty and inoperable, impacting project validations and schedules. There are several benefits garnered by implementing a fully integrated solution as mentioned above. In addition, a holistic approach promotes easy access to crucial scientific and business decision-making data.
Part 3 will discuss Effects of ALCOA, Big Data, Real Time Monitoring, and Authorization & Oversight.
Alpha Engineering LIMS Implementation
Alpha Engineering Associates, Inc. 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 Engineering Associates today at (410) 295-9500.