Klavs Esbjerg, CEO and founder of Epista Life Science, is on a mission to help his clients continuously improve regulatory compliance and in turn, transform their compliance obstacles (such as risk management) into real business opportunities.
The practical aspects of this vision are as important to regulatory bodies as they are to the companies Epista serves. To get clear on the real challenges facing the Life Science industry, in 2017 Epista pioneered a novel methodology that actually measures compliance in pharmaceutical, medical devices and biotech companies.
Here’s snapshot of sample and the survey:
- 35 sets of questions surveying all aspects of quality and compliance
- 38 Danish Life Science companies participated in the survey
- 90 percent had between 100 & 200 employees
- Almost an even split of employees vs. managers
- 80 percent of companies surveyed had been in business for 10-20 years
The results were profound, giving insight into not just overall compliance, but also into what Klavs calls the “quality culture” of a given company. This speaks to the intangibles that an organization does without actually stating that they do it – those behaviours that aren’t necessarily governed by written procedures, but that are more dictated by values.
Here are some of the key findings of Epista’s 2017 Study of Compliance Maturity:
- 73 percent of respondents said their company is very good at writing Standard Operating Procedures (SOPs) & felt confident about their Quality Management System (QMS).
- 79 percent felt they had adequate notice about and an awareness of regulatory quality requirements.
- 68 percent felt they had an established quality policy.
- 67 percent felt that quality policy was internalized throughout their company.
But then, reality check – here are additional, telling results:
- 51 percent said regulatory requirements and business requirements are seen as opposing forces.
- Furthermore, most said that employees are not consistently aware of the company’s quality goals, nor are they clear on how their work contributes to the overall organizational quality.
- Only 48 percent of the organizations surveyed said that they had real, defined Quality Management Systems (QMS) and processes in place.
- Just 58 percent said that quality is measured, but even if those cases these measurements are not typically used to drive process improvement.
- Only 20 percent periodically review quality guidelines and procedures.
These disparities in the results are telling: the same company that believes it “documents everything” – presumably to convince regulators that they are compliant – may not be anchoring their quality systems to anything that’s related to the actual processes within the company.
This phenomena may be in part due to the classic regulator’s stance, “if you didn’t document it, then it didn’t happen.” This leads to a landslide of paper documentation, and ultimately a compartmentalization of responsibility that separates quality assurance departments from the rest of the organization. It also wastes time, effort and money on what amounts to secretarial work, when those valuable resources could be put to better evolving business and regulatory practices aimed at boosting the bottom-line.
Klavs’ recommendation? Life Science companies must focus more on their processes to ensure they’re aligned with both business and compliance requirements. And quality management departments must be better integrated into the organization as whole in order to support a strong quality culture where values governing compliance are clear and consistent.
These game-changing insights can help companies pivot and focus on meaningful issues, from business challenges like price pressures and regulatory compliance, and technical challenges including adapting cloud-based solutions, integrating AI, and so on.
In the end, the survey says it all: how quality is executed company-wide is that key ingredient to determining today’s Life Sciences companies’ ability to survive – and thrive.
Klavs Esbjerg will share preliminary, hot-off-the-presses results from Epista’s 2018 Study of Compliance Maturity and speak about proactive quality risk management for Life Science companies at the one-day conference, “Practical Solutions in CSV and SDLC for GXP & MedDev” on 3 October in London.