Quality assurance

Batch record retention and archiving is a critical process in the pharmaceutical and manufacturing industries, ensuring that all production-related documents are accurately stored, preserved, and accessible over the mandated retention period. Batch records provide detailed information on the manufacturing process, quality control, and product release, making them essential for regulatory compliance, quality assurance, and traceability. Effective retention and archiving processes involve stringent organization, secure storage, and controlled access to prevent unauthorized use or tampering. Additionally, archiving staff must ensure both physical and digital records are managed with integrity, enabling quick retrieval during audits or inspections. This structured approach supports data integrity, enhances product accountability, and contributes to the organization’s overall compliance with industry standards and regulatory requirements.