The pressures are mounting for life sciences companies from both regulators and patients: increasing regulatory mandates, intense pressure on pricing and non-stop technological advancements. To thrive and take the lead, business leaders must address the new imperative head-on.
Compliance and regulatory functions have an opportunity to better align with business strategy and respond to external opportunities/pressure in a drive toward efficiency/effectiveness. Modern compliance organizations are risk intelligent, efficient, and deliver through business partnership and enablement.
With the advent of the COVID-19 pandemic, many companies have had to adapt to a new way of working very quickly. Many countries have installed working-from-home policies which have led to an unprecedented reliance on business-wide connected systems and software. Life Science companies that were previously reliant on paper-based or hybrid quality management systems have had to adapt to an increasingly and irrevocably digital world.
With a workforce that is working remotely rather than in offices, companies have been forced to develop new processes to remain connected and ensure quality and compliance standards are upheld throughout the company and its value chain.
Cloud adoption, agile ecosystems and connected platforms all combine to ensure that information isn’t lost through ineffective communication across departments and teams. This has enabled many Life Science companies to avoid missing issues that could have a dramatic effect, delaying projects, damaging their reputation, or even costing lives.
The rate of mergers and acquisitions that have been taking place within the Life Science industry, along with new quality software and IT systems being introduced all the time, have also led to many challenges. Companies merging and/or adopting different systems throughout the company make it more difficult to adopt comprehensive and uniform quality and compliance strategies.
Another way automation has been applied is to detect high-risk abnormalities in imagery through large-scale interpretation and processing of clinical trial data. Enterprises are reaping the benefits of adopting automation, and it is set to expand through the Life Science industry in 2022 as companies reevaluate how they can incorporate the technology in their business models.
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