Real-World Evidence of Workflow Excellence.
We don't believe in "one-size-fits-all" transformations. These case studies represent specific engagements where we partnered with pharmaceutical companies to solve defined operational challenges using workflow-driven software.
The Challenge
A mid-size manufacturing plant was operating on a 100% paper-based system. Batch records were frequently reaching QA with illegible entries or missing supervisor signatures, leading to release delays of 5–7 days. Manual transcription from weighing scales was a significant source of data integrity risk.
The Implementation
We implemented a custom eBMR system that mirrored their existing Master Batch Record (MBR) structure. We integrated the software with their digital weighing scales to automate data capture and enforced step-by-step sign-offs. The transition was phased over 12 weeks to ensure zero production downtime.
The Challenge
A growing pharmaceutical group was managing deviations and CAPAs using disparate systems across three manufacturing sites. Centralized quality teams had zero live visibility into site-level trends, making it impossible to identify systemic risks before they caused audit findings.
The Implementation
SQUETIKA deployed a unified QMS platform with site-specific workflows that aggregated into a central corporate dashboard. We implemented automated escalation triggers for overdue CAPA actions and built a custom reporting engine for quarterly quality reviews.
The Challenge
A clinical research organization struggled with tracking SOP read-acknowledgments for a rapidly expanding team. During a mock audit, they were unable to demonstrate that all personnel had reviewed the most recent protocol amendments before trial initiation.
The Implementation
We implemented an automated Document Management System (DMS) with a mandatory "Read & Acknowledge" workflow. The system restricts access to new protocol documents until the previous version's acknowledgments are archived and provides a one-click Audit-Ready Document Register.
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We don't ask you to change your processes to fit our software. We build the software to fit your process. Start with a consultation.