Sarcouncil Journal of Engineering and Computer Sciences

Abstract: Life sciences mergers and acquisitions pose unique challenges in harmonizing diverse IT systems while meeting regulatory requirements under international laws and frameworks, including FDA 21 CFR Part 11, EU GMP Annex 11, HIPAA, and SOX. This paper describes the challenges of harmonizing all aspects of IT for compliance after the merger, including system heterogeneity, audit-trail discontinuity, and conflicting standard operating procedures. The study design employed a blended methodology, combining case-study analysis of key pharmaceutical and medical device mergers with practitioner survey questions. The study proposes a four-phased harmonization process that includes compliance gap assessment, development of a unified control framework, system rationalization, and continual monitoring. It can be established that regulatory inspection readiness is achieved much faster for organizations that use a structured harmonization approach than for those that opt for an ad hoc integration approach. This research offers a viable governance process for computerized health-care compliance officials and CIOs who face the regulatory uncertainty accompanying life sciences mergers and acquisitions.