As discussed in Part 2, 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 3 will discuss Effects of ALCOA, Big Data, Real Time Monitoring, and Authorization & Oversight.
Effects of ALCOA
Every aspect of QA/QC operations may come under regulatory review, and so laboratories must comply with the chief principles of data integrity as mandated by the FDA in 2016. ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate) is now the laboratory mantra for data compliance, and its achievement is eased by acquiring data electronically as enabled by STARLIMS, rather than manually.
Big data is increasing the demands on storage on data archiving and storage. Although the SDMS capacity does not present a problem, determining the methods for the storage and retrieval become even more crucial. The use of manual entry and pen and paper records will not be satisfactory because QA/QC labs must verify the sources of data for audits. Thus, labs must integrate their LIMS platform with instrumentation, allowing the capture of data from the source. STARLIMS has this capability.
Real Time Monitoring
Utilizing electronic solutions, STARLIMS provides total visibility of all processes to all laboratory staff, whether on-site or off premises. Through comprehensive information collation, its electronic systems enable the application of real-time monitoring and analytics. This enables the pre-emption of problems related to SOPs, workflows, and test failures.
Authorization & Oversight
Weak security measures for logins and authorization are coming under greater regulatory concern. A strong compliant infrastructure is also needed to prevent the unauthorized manipulation of results. STARLIMS does not permit laboratory analysts or technicians to carry out tasks for which they are unqualified or lack proper training. In addition, they will not be allowed to assign samples for testing on uncalibrated instruments or instruments that have not undergone required scheduled maintenance. STARLIMS proactively supports measures that prevent errors that may prove costly and result in protracted investigations.
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.