Out of Specification Analysis Solution is a critical enabler for any quality centric organization that aims at improving the efficacy of their quality processes and their credibility. It leverages AI’s capability to perform deep analysis of textual information to extract actionable insights.

AI powered Out of Specification (OOS) Analysis Solution enables deep analysis of OOS data, extraction of Root Causes from them and their classifications by areas of accountabilities.

This will help the leadership to drive Targeted Analysis and Interventions.

For driving better adoption of Standard Operating Procedures and their compliance, organizations need to enable the employees with better access to SOP and implement techniques to guide them to the right information related to their specific SOP queries.

AI is very effective in situations that involves management of knowledge from a huge corpus of documents.

AI based Process Assistance Solution that is trained on a corpus of SOP documents will enable Deep Discovery and Contextual Reponses to the Process SMEs and Auditors, on queries related to SOP.

Highly competitive and regulated nature of markets necessitates pharma companies to be perpetually compliant and ready for FDA audits. Towards this they need to continuously analyse the audit observations of their peer companies and perform corrective actions, proactively. Conventional manual analysis of FDA observations tend to be error prone and time consuming.

AI’s capability to perform deep analysis of textual information to extract actionable insights can be leveraged here. AI based FDA Inspection Insights Solution performs deep analysis of 483 / Warning Letters and extracts key issues from the auditor observations. These insights will help pharma companies to efficiently drive targeted action plans and be more compliant and be “audit ready”.

Quality centric organizations - like pharma companies – look out for opportunities to reduce the OOS in their production batches by advanced process control techniques. AI based machine learning models are effective in optimization of decisions that involve multiple parameters with ‘not so evident’ correlations.

AI based production control systems identifies the critical Process Parameters at each stage of manufacturing and their impact on the Quality Parameters and the optimization of Process Parameters.

This will help pharma companies to drive targeted process control to improve the robustness of their products.

Pharma majors are actively exploring opportunities to drive efficient and cost effective innovation.

With loads of valuable and relevant drug related information available publicly, AI driven models can be leveraged to drive cost effective and efficient research and innovation.

Drug Repurposing solutions powered by AI can leverage publicly available drug related information and medical journals to explore newer opportunities for existing, approved drug / molecule, to target new indication or pursue new routes of administration