In the pharmaceutical industry, data integrity is not just a regulatory requirement—it’s a cornerstone of product quality, patient safety, and operational trust. At MFT Consult, we empower companies to embed data integrity into their culture by leveraging the ALCOA+ framework and aligning with international standards such as FDA 21 CFR Part 11.

 

“ Without data integrity, there is no data reliability. And without reliability, compliance is just an illusion.” — MFT Consult”

The Power of Data Integrity in Life Sciences

Data integrity ensures that pharmaceutical decisions are based on accurate, consistent, and secure information. It underpins compliance, product quality, and public trust.

Applying ALCOA+ and FDA 21 CFR for Lasting Compliance

The ALCOA+ principles and FDA regulations are the foundation for maintaining reliable digital and paper-based records in regulated environments. Implementing these effectively reduces audit risk and strengthens operational systems.

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Three Key Implementation Points:

1. Gap Analysis
   • Identify weaknesses in existing data practices and resolve issues before inspections.
2. Validated Digital Systems
   • Implement robust systems such as eQMS, LIMS, or MES that ensure traceable, compliant records.
3. Team Training
   • Train personnel on ALCOA+ principles to build a culture of accountability and accuracy.

FDA 21 CFR Part 11 Compliance
This regulation governs electronic records and signatures in regulated environments. It ensures digital data is trustworthy, retrievable, and secure. At MFT Consult, we support implementation through systems validated to meet these criteria.

How MFT Consult Can Help:

• Conduct comprehensive gap analyses across departments.
• Support the selection and validation of electronic systems tailored to your operations.
• Offer custom training sessions on ALCOA+, data handling, and audit readiness.
• Develop compliance roadmaps that align with global best practices and inspection trends.

Data integrity is not optional—it’s foundational. By adopting the ALCOA+ principles and ensuring FDA 21 CFR Part 11 compliance, pharmaceutical companies can safeguard their processes and reputations. MFT Consult provides the strategy, systems, and support to help you achieve compliance with confidence.

💬 Contact us today to explore how we can help you strengthen your data integrity framework.

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