STARLIMS’ standalone version of its Scientific Data Management System (SDMS) will help clients comply with Food and Drug Administration (FDA) requirements for data integrity.

ALCOA is an acronym for data integrity requirements coined by the FDA, which the European Medicines Agency enhanced with a “+” for four more essential qualities. ALCOA+ stands for attributable, legible, contemporaneous, original, and accurate, plus being complete, consistent, enduring, and available.

Laboratories’ standard data integrity issues involve using shared passwords, weak control of user privileges, no computer system controls, inadequately defined processing methods, insufficient data, and absent audit trails.

As a result, the FDA is increasingly sending warning letters to labs that do not follow Good Documentation Practices (GDP). Insufficient data integrity can result in import bans, facility shutdowns, product recalls, civil lawsuits, and decreased market share and brand value.

In December 2018, the FDA published the Data Integrity and Compliance with Drugs.

CGMP Questions and Answers Guide for Industry. This issue guided ALCOA data integrity and 21 CFR requirements to address industrywide GDP issues.

Moreover, the document defined an audit trail as “a secure, computer-generated, time-stamped electronic record that allows for reconstruction of the course of

events relating to the creation, modification, or deletion of an electronic record.” Instruments that are run should record the user name, a date/time stamp for each run, and any details regarding processing or reprocessing.

Numerous LIMS, ELN, and CDS solutions address most laboratory testing workflow-associated data integrity requirements. However, data integrity issues persist due to challenges involving handling, storing, and archiving raw and processed data, which may be worsened by equipment interfacing problems.

STARLIMS has determined the above problems threaten the Biotech, Pharma, and Healthcare industries significantly. Fortunately, the STARLIMS SDMS can help address data integrity challenges.

Part 2 will discuss the STARLIMS SDMS (Scientific Data Management System) solution.

Alpha LIMS Implementation

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