Your Product Can Pass Every Test… But Will Your Lab’s Data Pass the Audit?

Why Data Integrity Is More Than a Checkbox — It’s Your Client’s Trust Introduction

In the pharmaceutical world, passing analytical tests is only half the story. The other half? Ensuring your data is audit-ready. One in three FDA warning letters cite data integrity issues. That’s not a statistic — it’s a wake-up call.

Data integrity isn’t just about ticking boxes — it’s about trust, compliance, and your reputation.

Why Data Integrity Is Under the Spotlight

With increasing global regulatory scrutiny from bodies like the FDA, EMA, and CDSCO, the stakes for data integrity have never been higher. Failure to comply with data standards can result in:

• Batch rejections

• Product recalls

• Delayed submissions

• Loss of client trust and contracts

  
  

Top Data Integrity Failures in Pharma Labs

• Manual entries without audit trails

• Uncontrolled spreadsheet use

• Shared login credentials

• Non-validated software

• Lack of backup systems

  
  

These are more common than you think — especially in outsourced analytical testing environments.

ISO 17025:2017 and ALCOA+ Principles — Your Roadmap to Compliance

Modern labs must align with ISO 17025:2017 and ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available) principles to ensure trustworthy data systems.

At Hetero Analytical, our systems are:

✅ LIMS-integrated for real-time traceability✅ Built with audit trails and access control✅ Backed by validated software and trained analysts

Real Consequences: What Non-Compliance Costs

Even a single data integrity failure can derail months of work and cost companies millions:

• A failed audit can lead to site bans

• Clients may demand retesting or new data

• Regulators may initiate inspections or warning letters

  
  

How Hetero Analytical Ensures Audit-Ready Data

• Secure LIMS platform for traceable, timestamped entries

• ISO 17025-accredited methods

• Automated data capture from instruments

• Regular internal audits & integrity training

  
  

Whether it’s stability studies, method validation, or routine testing, our data systems are built to pass the toughest audits.

Final Word

Your product may pass every test — but unless your data passes the audit, you’re still at risk.

Partner with Hetero Analytical for data integrity you can trust — and clients can verify.