Measuring Digital Maturity in QA/RA and it's Regulatory Readiness in Pharmaceutical Industry: A cross organizational Study
| dc.contributor.author | Ragu, Gowtham | |
| dc.date.accessioned | 2025-12-22T10:21:15Z | |
| dc.date.available | 2025-12-22T10:21:15Z | |
| dc.date.issued | 2025 | |
| dc.description.abstract | This study looks at how digital maturity in pharma QA/RA work shows up in day-to-day practice and how it links to regulatory readiness. A 10-dimension Digital Maturity Index (DMI) was used as the overall lens; six dimensions were studied live in interviews (Strategy & Governance, Technology Infrastructure, Data Integrity & Records, Process Automation & Workflow, Compliance Readiness/Assurance, Continuous Improvement), and four were considered in the background (People & Capability, Supplier/Cloud Assurance, Master Data/Interoperability, Performance & Insight). Conducted six semi-structured interviews (P1– P6) across QA/MES and RA operations. Transcripts were coded line-by-line; themes were compared across cases; each dimension was rated 1–4 with a one-line reason. Findings are clear. Controls are steady: people describe draft → review → approve, role-based access, “supersede, not delete”, and audit-trail checks. These behaviours sit at level-3 and relate to smoother submissions and stable audits. Differences in readiness come from flow, not from the basic control layer. Where MES/workflows stop on exceptions and manual pockets sit outside systems (e.g., RA reuse/notifications in spreadsheets), cycle-time increases and people do double work. Where teams added small pre-checks or used auto-routing, clock-stops reduced and movement was faster. Technology is mostly stable, but integration gaps (e.g., RIM↔EDMS duplicate typing) and one paper-heavy site explain delays. In RA, one case showed level-4 assurance due to a full change → submission → approval trace. The study suggests practical fixes that can be done this quarter: write a short rationale in periodic reviews; add pre-checks at the common stop points; align 8–10 master-data fields between systems; keep a tidy supplier pack; and make the weekly pipeline data-led with two simple KPIs. These small steps connect digital maturity to everyday readiness: fewer queries, fewer clock-stops, shorter cycle-time, and smoother approvals. | |
| dc.identifier.uri | https://hdl.handle.net/20.500.14136/292 | |
| dc.title | Measuring Digital Maturity in QA/RA and it's Regulatory Readiness in Pharmaceutical Industry: A cross organizational Study | |
| dc.type | Thesis |