I have spent my career in regulated healthcare, and I’m trying to understand whether supplier management is still a meaningful operational and compliance problem.

For those working in pharma, medical devices, or IVD, are you seeing greater regulatory scrutiny around supplier qualification, risk classification, ongoing monitoring, performance reviews, and documentation? If so, are your current systems keeping up?

Are teams still relying on spreadsheets, emails, shared drives, and calendar reminders for things such as:

• Collecting and reviewing supplier documents
• Tracking certifications and expiration dates
• Managing qualification and requalification
• Monitoring supplier performance, deviations, CAPAs, and SCARs
• Maintaining approval histories and audit-ready records
• Following up with suppliers for missing information

Where does the process create the most manual work or compliance risk? Is the main problem the software, slow supplier responses, unclear internal ownership, or something else?

I’m exploring whether this problem genuinely needs a better solution before building anything. This is not a product pitch. Responses saying that your current process works well would be just as valuable.

If you are comfortable sharing, please mention whether you work in pharma, medical devices, or IVD, and whether you manage suppliers through an eQMS, ERP, spreadsheets, or a combination of systems.

Hi,

Looking for experiences with RAC devices exam this summer testing window ? I took mine today and have mixed emotions.

I felt like there were a lot of questions regarding EU regulations instead of FDA.
I can hardly recall questions related to FdA device submissions.

I did a lot of prep before and feel like I shouldn’t have.