Tag: submissions

Addressing ERES Control Failures During System Upgrades to Prevent Part 11 Noncompliance In an environment where regulatory compliance is paramount, the implementation of ERES controls plays a critical role, especially…

Addressing ERES Control Issues During Inspection Walkthroughs In the realm of pharmaceutical manufacturing and quality control, the implementation of Electronic Records and Electronic Signatures (ERES) controls is critical. This is…

Managing Hybrid Paper-Electronic Workflow Risks During Inspections The increasing reliance on hybrid paper-electronic workflows in pharmaceutical manufacturing can lead to control issues, particularly during regulatory inspections. This article presents a…

Addressing Weak System Access Controls During the System Upgrade: A Comprehensive Playbook In today’s pharmaceutical landscape, ensuring robust system access controls is paramount, especially during system upgrades. Weaknesses in these…

Addressing Uncontrolled Hybrid Paper-Electronic Workflows During Inspection Walkthroughs In recent regulatory inspections, hybrid paper-electronic workflows have become a significant area of scrutiny. When not managed correctly, these workflows can lead…

Managing Record Retention Challenges During FDA/EMA/MHRA Inspections In today’s regulatory landscape, adherence to record retention requirements is non-negotiable, particularly under 21 CFR Part 11. Failures in maintaining accurate records can…

Addressing Record Retention Failures During Inspection Walkthroughs: A Comprehensive CAPA and Revalidation Playbook In the highly regulated pharmaceutical environment, the integrity of record retention is pivotal for compliance during inspections.…

Addressing Record Retention Failures in the Validation Lifecycle for Compliance In pharmaceutical manufacturing, ensuring robust compliance with regulatory frameworks is critical. Record retention failures are a significant concern during the…

“`html Addressing Misuse of Electronic Signatures in System Operations: A Risk-Based Remediation Playbook The increasing reliance on electronic records and electronic signatures (ERES) in the pharmaceutical industry brings significant regulatory…

Managing Uncontrolled Hybrid Paper-Electronic Workflows in Pharmaceutical Operations In today’s pharmaceutical landscape, integrating hybrid paper-electronic workflows has become a necessity. However, uncontrolled workflows during system operation can lead to significant…