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Start Small & Smart with Regulatory Automation

May 08, 2020
Regulatory Automation

Companies who did large implementations (like RIM, EDMS, Change Management, ERP, others) have all noticed their costs and timelines doubled than what is budgeted initially.

These large systems that BioPharma implemented have helped them streamline business functions and track data. However many of these systems still require significant manual processing. PwC's 2017 effectiveness benchmark report found that users spend half their time focused on mundane, repetitive tasks of gathering data from various systems. This led to many of the systems reaching the point of diminishing returns.

On positive side, the speed, scale and cost of automation are evolving better with help of robotic automation, natural language processing, machine learning systems that offer companies new opportunities to improve process performance and realize significant cost savings

For Regulatory processes, some of these technologies can be implemented in short sprints, focused on specific sub-processes, with manageable costs. This approach of "small & smart" automation leads to "fast" implementation of flexible and adaptable technologies that fill the gaps left by your current or legacy enterprise tools or document systems, thereby enabling much higher productivity for labeling teams

Small automation can improve the productivity of individual regulatory processes by 80 to 100 percent and overall labeling functions by 30 percent or more

Small automation does not replace large enterprise systems or your future big automation initiatives. These are easier to implement and much less expensive. They can be applied to individual processes or tasks without having to go through complex cross-functional discussions (negotiations) and coordination in large projects.

Traditionally, companies could not begin to capture gains from large IT implementations until they had standardized processes and databases that were accessible to a broad set of users, which could take years. In contrast, automation doesn't depend on standardization or centralization (unlike your large projects or systems) leading to higher flexibility and adaptability

Applying small automation is anew way of working, and company leaders will need to ensure that both they and their teams have right knowledge to be successful.

"small" automation can be applied to several processes like auto authoring, data with document merging, document publishing, submission readiness checks, translation automation, compliance checks, broad QC checks, and few more areas

Please reach out to us to discuss how we are helping customers achieve these automation goals using our patent-pending REGai which is a cloud based modular focused Regulatory platform that will work with your current systems / technology


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