Part 3 will cover Holistic Solution Advantages and ALCOA Effect.

Holistic Solution Advantages

Providing an end-to-end solution, STARLIMS eliminates the issues that arise when laboratories have to deal with several vendors for support and resolving issues.  The implementation of one holistic solution decreases the chance that add-ons and modules will not work as designed, hindering tasks and delaying schedules.

Modern LIMS solutions provide electronic signatures and secure audit trails for compliance with 21 CFR Part 11. It will enable calibration and maintenance, equipment validation scheduling, and the verification of authorized users for training and particular analytical procedures. Combining this function with a comprehension of materials, processes, and samples with predictive analytics, a LIMS is capable of noticing trends, highlighting outliers, and notifying specific staff to assess and act.

Whether cloud-based or on-premises, a solid LIMS infrastructure will be user-friendly and in accord with the business rules of a laboratory. In addition, authorized users, such as laboratory staff and executives, will be able to easily access and review key data in real-time. Comprehensive data will provide insights that will allow leaders to make sound decisions regarding business initiatives and laboratory management.

ALCOA Effect

It is possible that each aspect of QA/QC data acquisition, handling, lab operation, and management will come under the scrutiny of regulators. Thus, a laboratory should adhere to the key principles of data integrity. As set forth by the FDA in 2016, data should be complete, consistent and accurate.

Thus, the acronym ALCOA (attributable, legible, contemporaneously recorded, original or a true copy, and accurate) has become the mantra for all labs aspiring to achieve data compliance. Since data acquired or created may come under regulatory inspection, meeting ALCOA principles is eased when data is electronically acquired.

STARLIMS Integrated Solution

Implementing state-of-the-art technology, STARLIMS provides a totally integrated solution that incorporates LIMS, Electronic Laboratory Notebook (ELN), Scientific Data Management System (SDMS), Advanced Analytics, and Mobile within a single application. This innovation makes building and maintaining custom interfaces required by third-party tools unnecessary.

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.