Comprehensive Pharmacovigilance SOPs
Standard operating procedures, or SOPs, are quality documents critical to any pharmacovigilance (PV) quality system. Experienced PV professionals need to dedicate time and diligence to ensure these documents are clear, concise, and easy to follow. SOPs need routine content review to ensure they are in compliance with current regulations.
Although it is well known that a list of SOPs is one of the first items to be requested during an FDA inspection, lack of or inadequately written SOPs, or failure by the companies to follow their own SOPs, are still one of the most common inspection findings.
Knowing the challenges that our clients face, Med Communications offers our clients a comprehensive PV SOP package that is:
- Fully auditable
- Regularly reviewed
- Maintained by Med Communications through our own Quality Management System
Companion documents, such as Work Instructions and Handling Guides, are also created to provide the client-specific and product-specific details necessary to effectively manage your safety information. With Med Communications’ team of experts, we can ensure your SOPs and companion documents are inspection ready. Contact us for more information on how we can help build or manage your PV SOPs: 877-477-0977 or https://medcommunications.com/contact-us/