Why Life Sciences ERP Validation is Complex and Always Ongoing

In life sciences, ERP validation is key to maintaining compliance with regulatory standards like GxP. It ensures your systems are accurate, secure, and always performing as intended. 

Take this scenario: A pharmaceutical company rolled out a new ERP system but skipped proper validation. Soon enough, they faced issues like batch record discrepancies and data entry errors. The outcome? Production delays and warning signs from regulators put them at risk of expensive fines. 

In contrast, another company that invested in a robust validation process saw no such issues. Their validated ERP system ensured that every process was consistently followed, with full audit trails, secure data handling, and reliable performance. This proactive approach not only kept them compliant but also minimized risks, saved time, and helped them avoid costly recalls.  

The risks of skipping ERP validation are huge. It could cost you: 

• Fines: Costly penalties from regulatory agencies 

• Recalls: Quality issues that disrupt supply chains and delay progress
• Reputation: Compliance failures damage trust and credibility
• Patient Safety: Errors that could compromise lives  

For life sciences businesses, validation is the foundation for compliance, operational efficiency, and delivering safe, effective products to the people who need them the most.  

The Complexity of ERP Validation   

ERP validation is non-negotiable for a life sciences company. But here’s the catch—it’s not a one-and-done task. Keeping your systems validated is a continuous process. Every system update, patch, or change triggers the need for re-validation to maintain compliance and data integrity.   

Your ERP system evolves with your business. Whether you are rolling out technical updates, adding new workflows, expanding into new markets, or responding to regulatory shifts, each change calls for fresh validation to stay in the clear, and every change—whether technical updates, new workflows, market expansion, or regulatory shifts—requires ongoing validation to maintain compliance. So, what are the changes that require your ERP systems to be re-validated?

• Technical Updates and Workflow Changes: System updates or workflow adjustments can affect data processing or integrations. Validation ensures nothing slips through the cracks after these changes. 
• Market Expansions: As you enter new markets, your ERP must align with different regulations and requirements. Validation ensures your system supports compliance wherever you operate. 
• Regulatory Changes: Regulations keep changing. Ongoing validation ensures your ERP keeps pace with evolving standards like GxP and regulatory (FDA, European Medicine Agency). 

Even minor software updates can impact how the system performs, so ongoing validation keeps your operations in check. Overlooking re-validation is risky. It can lead to compliance gaps, audit failures, fines, and even product recalls. In life sciences, that’s a risk you can’t afford.  

Common Challenges Life Sciences Companies Face During ERP Validation 

Validation is a journey full of challenges. Life sciences companies face constant regulatory shifts, the frustration of outdated manual methods, and the pressure to keep pace with evolving cloud technology—challenges that can derail the validation process. But tackling these hurdles starts with understanding them. Let’s explore the most common validation challenges:

Understanding How to Verify the System

Pharma companies often hit roadblocks when verifying systems due to complex regulations and software intricacies. Companies struggle with the time-consuming task of building their validation requirements list from the ground up. 

Defining the Validation Scope

If the scope is too narrow, you risk missing critical areas. If it is too broad, you waste time and resources. The key? Finding the right balance to stay compliant without stalling progress. 

Tracking Configuration Changes

Systems evolve, updates roll in, and keeping up with configuration changes is critical. However, pharma companies often struggle to track and validate these updates, giving way to compliance risks and performance issues. 

Manual Validation Bottlenecks

Manual validation drains resources with endless paperwork, repetitive testing, and human error. It’s slow, inefficient, and delays projects—pushing timelines and people to the limit. 

Flaws in Documentation & Testing

Messy documentation is a disaster waiting to happen. Errors in test scripts, results, or audit trails can trigger compliance violations and regulatory risks. 

Ensuring Ongoing Compliance

Keeping up with constant change while staying compliant is no easy task. New processes, evolving partnerships, and software upgrades demand that pharma companies adapt quickly—without ever missing a beat on compliance. 

Outdated Validation Methods

Outdated validation methods can’t keep up with today’s complex systems and shifting regulations. Obsolete techniques mean longer cycles, missed automation, and bigger compliance risks. 

Why STAEDEAN Life Sciences Toolkit? 

At STAEDEAN, we stay ahead of the curve when it comes to keeping up with the changes in regulations. We continually refine our validation processes to keep up with the changes, like moving from CSV to CSA. By focusing on comprehensive risk assessments and precise documentation, we provide the essential tools and strategies to help you meet evolving standards with ease and confidence. 

STAEDEAN Life Sciences Validation Toolkit is built to streamline the validation process, cut costs, and minimize errors. Developed to help you in your efforts to comply with GxP, it makes your entire validation process simple and efficient. 

Here’s how we simplify validation: 

• Expert-Driven: Applying a critical thinking approach to ERP implementation in alignment with ISO 9001 standards. 
• Risk-First Approach: With a strong emphasis on risk assessment and documentation, we provide the most effective validation methods and templates to help you stay compliant with new standards.
• Efficiency-Focused:  
  • Ready-to-use templates to save time and resources
  • Set of libraries including Testing library and automated solutions to limit errors and cost 
  
  
  

With the STAEDEAN Life Sciences Validation Toolkit, life sciences companies can: 

• Increase Efficiency: Identify inefficient processes and speed up operations.
• Cut Costs: Reduce validation expenses with an easy-to-use validation toolkit.
• Mitigate Risks: Improve accuracy by moving away from manual processes.
• Get Compliance Support: Get assistance in your efforts to comply with FDA and GxP.
• Stay On Course: Meet your deadlines and budgets without compromising quality.

Take Charge of Your ERP Validation Process 

Explore a detailed validation roadmap and gain insights into how the STAEDEAN Life Sciences Validation Toolkit addresses your toughest validation challenges.