Even without the implications of Brexit, these are turbulent times for regulatory teams. Compliance has become a full-time job, and administrative demands are on a permanently upward trajectory.
The more rules there are, and the more frequently these change, the greater the risk of something going wrong (with product labelling, for example). Often it is highly skilled employees, people with doctorates, who are called up to check amended labels and patient literature to ensure it is correct and up to date.
Yet these experienced Regulatory skills are in short supply. A 2014 survey by Real Staffing found that Quality Assurance and Regulatory Affairs are among the main growth disciplines in life sciences. It also identified a widening skills gap.
Repetitive, non-value-added tasks are demotivating and a poor use of professionals’ time. It also adds stress and removes the sense of reward from people’s work. TalentKeepers (The Dirty Truth: Employee Turnover Costs, 2015) has found low morale to be one of the largest determinants of employee turnover and poor engagement currently. This is as costly as it is inconvenient: the financial impact of losing a skilled employee can be twice their annual salary.
Service quality can suffer too if people’s hearts aren’t in the task, which is worrying in Regulatory Affairs where attention to detail is so critical.
In situations like these technology usually comes to the rescue, alleviating repetitive manual tasks so that skilled employees can use their talents more constructively. But when it comes to checking the minutiae of pharma product labelling, it isn’t quite so straightforward. There are so many subtleties at work that companies haven’t been able to trust software to make the right judgement calls.
But things have moved on, and it’s now possible to automate several rounds of regulatory checks, allowing professionals to focus their time where it is needed. This means expert time can be saved for final oversight.
Tools based on Unicode text comparison take just minutes to reliably pinpoint even the tiniest variations in a document comparison. Average savings can add up to five hours a week on manual proofreading/text verification. Against the average salary of a specialist Regulatory Affairs employee (estimated at $85,000 or EUR 76,000), this works out at a yearly saving/productivity increase of $13,500 (EUR 12,000) per RA user.
Reducing dependence on manual processes is a futureproofing strategy too. A rise in life sciences merger and acquisition activity, and the growing trend of smaller batch numbers and increased drug personalisation, means label demands are soaring and becoming more complex to manage. Each new demand multiplies the burden on RA and QA functions to be responsive, accurate and thorough at a time when there is almost no capacity to spare.
All of this demands new ways of managing the workload.
This article is taken from Pharmiweb, July 2016