Life Sciences Enterprise Systems Survey Trend Report

Research focus

This trend report focuses on the following:

• Biggest administrative, compliance, and operational challenges
• Satisfaction with ERP or enterprise systems
• How ERPs are implemented and how well elements of ERPs meet business goals
• Compliance with ERES
• Future focus areas to improve business processes

Key observations

Compliance challenges

• 46% experience challenges with FDA Title 21 CFR
• 33% with cGMP
• 28% with GMP

ERES-compliant digital signature solutions

Only 18% of survey respondents said they have a fully compliant ERES digital signature solution.

Biggest operational and administrative challenges

• 54% struggle with supply chain visibility
• 48% have difficulty with forecasting

Future focus to improve business processes

• 59% will focus on analytics or reporting
• 43% will focus on forecasting and trend analysis
• 39% will be focusing on compliance and regulatory management to improve business processes

ERP implementation

• 32% have an on-premise ERP
• 34% have an ERP that is cloud or SaaS-based
• 16% have a hybrid implementation

Challenges with supply chain disruptions

• 52% are experiencing challenges with inventory management
• 42% have difficulty with their tracking and traceability due to supply chain disruptions

Satisfaction with current ERP or enterprise system

• 30% are satisfied or very satisfied with their existing ERP
• 48% are neutral
• 22% are not satisfied

What are some of the biggest operational challenges?

Supply chain visibility was the most common challenge for survey respondents, which is not surprising in light of the supply chain disruptions in the news. The knock-on effects of supply chain issues can be seen in other challenges, such as inventory tracking, procurement, and production planning.

What are some of the most significant administrative challenges?

Forecasting is generally a complex discipline to master, and the added issues arising from supply chain disruptions and economic uncertainty make it even more challenging.

Inflation is likely making cost analysis a more difficult task as well. Various regulatory issues collectively present a significant administrative challenge for life sciences companies.

Which of the following are the biggest compliance challenges?

FDA Title 21 CFR is a complex compliance challenge since so many elements need to be addressed, such as audits, systems validation, electronic signatures, and more.

GMP and cGMP also represent significant technical challenges to ensure the proper design, monitoring, and control of all manufacturing operations.

What are the biggest challenges brought about by supply chain disruptions?

Like other industries, life sciences must manage significant administrative overhead with inventory management.

Tracking and traceability is also a critical compliance hurdle coming shortly, and supply chain issues likely exacerbate this.

As disruptions in the global supply chain persist, onboarding vendors efficiently is now a competitive advantage.