Background
A global pharmaceutical manufacturer required remediation and compliance support for its computerized packaging systems, including serialization lines, to address regulatory gaps and improve operational efficiency.

Challenge
The packaging lines had gaps in procedures, training, and validation strategy, resulting in incomplete testing of product features and potential data integrity risks. Systems also relied on generic passwords, increasing vulnerability and non-compliance.

Approach

• Performed a GAP analysis of computerized systems, identifying missing procedures, inadequate training, and weaknesses in validation strategies.
• Implemented system security improvements, including:
  • Removal of all generic passwords from machine HMIs.
  • Development of administration SOPs to enhance data integrity and regulatory compliance.
• Developed a requalification project plan to serve as a template for all future packaging line requalifications.
• Introduced operational improvements to enhance packaging efficiency, including:
  • Line/machine settings lists for each product.
  • Standardized change parts to reduce setup time.

Outcome

• Successful remediation of computerized packaging systems, improving compliance with GMP and data integrity requirements.
• Operational efficiency improvements reduced line setup times and increased packaging throughput.
• Established a requalification template for consistent future compliance activities.

Key Takeaway
Targeted GMP/CSV consulting, combined with process improvements and system security enhancements, ensures regulatory compliance while increasing operational efficiency across packaging lines.