Efficient remote auditing to help Pharma companies
On-site audits can be replaced by well-organized remote auditing. There is a need for frequent auditing in Pharma business. Most of these audits can be carried out remotely. Document reviews and interviews can easily be conducted remotely. When remote audits are well planned and organized, they are as efficient as on-site audits.
At Biocodex Nordics Pharmaceutical and Medical Services, PhaMe, we have developed an efficient process for performing remote audits. Our certified auditors master different GxP areas. Our expertise encompasses, for example, pharmacovigilance, GMP, GDP and registration audits, mock audits in preparation for official audits as well as internal audits – anywhere in the world.
Our remote audits consist of:
- Pre-audit questionnaire for the subject area as well as pre-material requests
- TC/video interviews
- TC/video document review
- Audit report
- CAPA follow-up
- If necessary, a translator will be available for support during the audit.
Why remote auditing?
- Cost-effective (no travel expenses and working hours missed due to travelling)
- Reachability to countries where travelling is not recommended
- Local documents and SOPs are often available in the local language, so interviews have an important role.
- In some areas outside the EU, the local legislation is not as advanced as in the EU, so the agreements are the main reference material utilized in the audit.
About the author
Susanna Heinonen works as the Head of Pharmacovigilance for Biocodex PhaMe. A total of 10 years of working with various local and global pharmaceutical companies has given her expertise and insight into different subject matter areas and pharmaceutical industry in general. Susanna’s focus areas include pharmacovigilance (PV), Good Distribution Practices (GDP) of medicinal products, and medical marketing compliance (PIF and EFPIA Code of Ethics for pharmaceutical marketing).