by Prakash Achaary | Jan 10, 2024 | Blog
Change management in the pharmaceutical industry is Part 2 in our conversation on computer system validation (CSV). As discussed in Part 1, the increase in the use of automated manufacturing and quality systems is forcing an increased exposure on computer systems...
by Prakash Achaary | Jan 4, 2024 | Blog
Computer system validation (CSV) is a core item that regularly comes up during regulatory inspections. And, the US Food & Drug Administration (FDA) conducted 2,442 inspections in 2022, according to a recent report. To ensure inspection readiness, a two-part series...
by Prakash Achaary | Dec 27, 2023 | Blog
Clinical data science is growing exponentially, as the Bureau of Labor Statistics confirms that the need for data scientists is rising faster than other areas with a 35 percent project growth rate through 2032. And, as the pharmaceutical industry has seen in the last...
by Prakash Achaary | Dec 20, 2023 | Blog
Background Cell and gene therapies (CGT), often referred to as advanced therapeutic medicinal products (ATMPs), are rapidly emerging as favorable treatments, repeatedly targeting rare, ultra‑rare diseases and fall under regulators’ expedited programs [1]. To date, the...
by Prakash Achaary | Dec 14, 2023 | Blog
Data provenance in Real World Evidence (RWE) studies has quickly becoming an increasing focus in the industry, especially as 90% of pharmaceutical companies today have Real World Evidence teams according to Deloitte. If an audit is underway, for instance, consider an...