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The client, already on a path to digital transformation, had successfully digitized most of their operational processes using our digital solutions. However, their Out-of-Specification (OOS) and Out-of-Trend (OOT) processes remained manual, creating a disconnect in their otherwise streamlined digital workflow. This gap not only hindered the efficiency and accuracy of their quality management but also made it challenging to synchronise these critical processes with their existing digital platform. The client sought to fully integrate and digitize their OOS and OOT processes to achieve seamless operations, enhanced data integrity, and improved regulatory compliance.
Despite the significant digital advancements, the client’s OOS and OOT processes were still managed manually. This manual handling led to delays in investigations, increased potential for human error, and reduced overall efficiency. The paper-based nature of these processes created bottlenecks, slowing decision-making and corrective actions.
The disconnect between the manual OOS and OOT processes and the already digitized eQMS created a significant challenge. This lack of integration made it difficult to maintain a consistent flow of information. Consequently, there was a risk of data discrepancies and misalignment, affecting the overall quality management system.
We transformed the client’s OOS and OOT processes by fully digitizing them, replacing manual paperwork with electronic forms and workflows. This change made data capture and management more efficient, eliminating the reliance on paper records and reducing the chances of errors.
Additionally, we seamlessly integrated these digitized processes into the client’s existing digital systems, allowing for real-time synchronization of data across all quality management activities. This integration ensured consistency and transparency in their operations, while the automated workflows enabled quicker decision-making and improved follow-up actions, enhancing overall efficiency.
Our team collaborated with the stakeholders to gather detailed requirements for the OOS and OOT processes. We thoroughly understood the current manual workflows, pain points, and desired outcomes.
QEdge’s workflow configuration tools were utilized to design digital workflows that replicated and improved upon the manual processes. The workflows included steps for OOS/OOT logging, investigation, root cause analysis, corrective and preventive actions (CAPA) identification, and approvals.
We organized workshops and training sessions to teach users how to initiate and track OOS/OOT incidents and generate reports. This structured training and implementation approach ensured a smooth transition to digitising OOS and OOT processes, enhancing efficiency, data integrity, and user adoption.
With QEdge, bring all the quality processes such as Change Control, Deviation, Investigation, CAPA, Market Complaints, OOS, OOT, Risk Assessment and other quality related activities like SOP management, Training management, Audit management, Vendor qualification and PQR/APQR on a single platform.
Experience a Digital Transformation journey with a trusted automation and digitization partner. To start, email us at sarjen@sarjen.com or visit qedge.sarjen.com.
Sarjen Systems has been serving the Pharma & Life Science industry for the last 25 years. We keep updating our products on a regular basis to serve our customers with products that are compliant. Our products are greenfield products and technologically updated as per requirements.
QEdge Quality Management Software Suite
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6th Floor, Arista, 100 Feet Anand Nagar Rd, Jodhpur Village, Ahmedabad, Gujarat 380015
Phone : +91-79-66214899
Email: sarjen@sarjen.com