According to MasterControl’s 2022 Digital Quality Maturity Study conducted by Cicero research, the majority of quality organizations are going digital, have plans to go digital within the next five years, or believe this is where they need to go to achieve compliance and remain competitive. However, a high number of companies still design quality management systems around manual, paper-based, or hybrid processes which are error-prone, disconnected, and cause delays. Believing that most of their competitors are more digitally mature than they are, and that they need to digitally transform to get ahead, companies still hesitate to implement software solutions.
Regardless of their size, the primary barrier that quality organizations face is the belief that the cost of an advanced quality management system (QMS) outweighs the benefits that come with it. Unfortunately, this is the costliest mistake that companies can make at a time when industry leaders are continuing to invest in software solutions, especially those that support emergent technology, which is a dramatically and rapidly changing industry itself. Pharmaceutical companies, for example, are investing in more patents related to artificial intelligence (AI)[i]and hiring more talent skilled in AI to prepare for, develop, and monitor this technology than any other sector.[ii] Mentions of AI in pharmaceutical company filings increased 105% between 2016 and 2021.[iii]