As the pharmaceutical, bio-pharmaceutical and medical device business passing through the Pandemic crisis, with very high demand of emergency medicines, vaccines and preventive devices in an environment of highly controlled limited mobility of workforce and supply chain. The future business model of the time demands a balance of working from remote/ virtual platform, admixed with conventional physical manpower oriented on-the-site functioning. The trend and evidence is quite predictive, human civilization is expected to live with similar future crisis predominantly, the foresight of drug manufacturing and supply will phenomenally reliant on digitalization & automation, with the delegation from virtual and conventional platforms in parallel.
Our team is confident enough in supporting your organization in laddering the QUALITY standard from quality-by-design to quality-by-compliance to predictive-patient centric-quality in this digital era, that sustain growth of the next generation quality system. We have path-breaking trend in delivering 30-40% increases in productivity in testing, and a full range of improvements leading to about 50 percent reductions in overall quality control costs. We have showcased that digitization and automation ensured better quality and compliance by reducing errors and variability by more than 60%, as well as allowing faster and effective resolution of problems over 75% percent faster closure times.
. Assessment of digitalization and automation in build and mapping of automation requirement
. Mapping of knowledge base available for the digital manufacturing and assurance of quality, redesigning of roles, KPI and mechanism of governance
. Risk based approach to derive the scope for working on digital vs conventional platform with meaningful science and technology, intended for better reliability and throughput
. Stepping up the process of agile digitally-enabled quality/ automated quality/ distributed quality
. Exploration of possibility to employ digital tools like Smart-glasses, Pokemon-go for simplifying documentation and personalized work instruction
. Standardization of quality system compliance with the help of AR guided artificial intelligence, cobot, robotics, LIMS, cloud computing, software interfaces, RFID, mobile devices, etc
. Real time microbial monitoring, lighthouse, reduction of testing with statistical database, upgrading to NIR and Raman spectroscopy, control of the CPP and CQA with dynamic limits of trends, etc.
. Conceptualizing dynamic scheduling, live document review, RM/PM release and batch approval/ rejection at unit/ corporate level, video collaboration with supervisor and experts
. Virtual training and effectiveness, deviation, investigation of failure and CAPA, validation, APQR, dossier filing, etc. Use of PAT and parametric batch disposition decision
. Remote audit of the vendor, supplier, CRO, and manufacturing; assessment of preparedness to face a remote regulatory audit, response to regulatory audit observation, PAS filing.
Copyright © 2019 - 2022 Qualxcl Technical Consultancy Services | Designed & Developed By InfoSky Solutions