Achieving Regulatory Excellence In a Virtual Environment: Is Pharma Ready?
Virtual operations have become a necessity in Pharma due to travel restrictions, quarantines, social distancing and absences imposed due to the Covid-19 pandemic. Working from home became the norm and in-person activities as audits were no longer allowed. Health Authorities have delayed on-site inspections which has delayed some approvals.
Regulatory requirements and regulations have not changed. Regulatory oversite and approvals are based on documentation, transparency, historical performance and risk. Regulatory excellence and success rely on evidence and proof. Data must be accurate and data integrity ensured. Quality Assurance must review and approve quality-related documents and data. Data must be available in a readily-retrievable manner throughout the retention period. The requirements have not changed but approaches to meeting the requirements have changed.
• What are the regulatory requirements?
• What are virtual operations?
• What has changed?
Mark R. TePaske, Senior Director of Global Regulatory Affairs, Quality and Compliance