Tag: inspection

Addressing Record Retention Failures during System Operations – A Comprehensive Playbook Record retention failures during system operation pose significant risks to data integrity and compliance within the pharmaceutical industry. These…

Addressing Record Retention Failures During System Operation: An Inspection-Ready Playbook In the pharma manufacturing landscape, record retention failures can lead to significant operational challenges, especially during inspections. These failures can…

Managing Compliance Gaps in Hybrid Paper-Electronic Workflows During an Audit In the evolving landscape of pharmaceutical manufacturing, hybrid paper-electronic workflows pose significant challenges, particularly during compliance audits. When these workflows…

Addressing ERES Control Failures During the Validation Lifecycle to Avoid Part 11 Findings In today’s pharmaceutical landscape, the integrity of electronic records and electronic signatures (ERES) is paramount. Failing to…

Enhancing System Access Controls to Avoid Part 11 Findings During Inspections The integrity of pharmaceutical manufacturing processes heavily relies on stringent system access controls, especially in the context of electronic…

Managing Uncontrolled Hybrid Paper-Electronic Workflows During System Upgrades During system upgrades, the integrity of hybrid paper-electronic workflows can often become compromised, leading to potential non-compliance and data integrity issues. In…