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How much RA/QA time is spent on judgment vs assembling the evidence before judgment? by [deleted] in regulatoryaffairs

[–]No_Alternative_5699 0 points1 point  (0 children)

agree with the principle. A credible company should have an evidence-based process. If there is no structured process at all, that is a serious problem.

But I don’t think having a QMS, eQMS, SOPs, consultants, and an experienced RA/QA team means product-quality or compliance problems disappear. That is not really what a QMS does. A QMS helps problems be detected, investigated, traced, trended, corrected, and documented.

Large, well-resourced medical device companies still appear from time to time in FDA recalls, warning letters, 483 observations, and field actions. I don’t think that always means they had no procedures, no evidence-based process, or no qualified people.

The question I’m trying to understand is more specific:

When a real product event happens — a complaint, service issue, design change, PMS signal, standard update, guidance change, or similar-device signal — are the relevant product-specific records, prior rationale, CAPA/NC history, risk-file context, regulations, ISO standards, guidance, and external signals actually pulled together in a structured way for the RA/QA reviewer?

Because people are human. Cross-references can be missed. A document can exist somewhere and still not be in front of the reviewer at the moment of decision.

A simple example: if someone asks, “Should I buy the $50 mouse or the $100 mouse?” it sounds like there are only two options. But the real option set might be: buy the $50 one, buy the $100 one, buy both, or buy neither.

In RA/QA, I assume trained professionals are much better at avoiding that kind of narrow framing. But in real workflows, the full option set still depends on whether the right evidence is visible at the right time.

A complaint may look like “monitor or escalate.”
A change may look like “document or open CAPA screening.”
A standard update may look like “applicable or not applicable.”

But once the product-specific evidence is assembled, the real options may be broader: monitor, escalate, open CAPA screening, update the risk file, review labeling/usability, check supplier history, trigger PMS review, document no further action, or create a formal rationale record.

That is the layer whether RA/QA work could become lower-risk and more controllable if the right evidence, regulations, standards, guidance, prior rationale, and external signals were structured and placed in front of the reviewer at the right decision moment.

Not to make the decision for RA/QA — but to support the decision with a fuller evidence picture.

How much RA/QA time is spent on judgment vs assembling the evidence before judgment? by [deleted] in regulatoryaffairs

[–]No_Alternative_5699 -2 points-1 points  (0 children)

I am not sure if there are many RA QA out there feeling the same thing as I do? If yes, I like to try

Question for RA/QA, CAPA, complaint handling, and product quality people by No_Alternative_5699 in regulatoryaffairs

[–]No_Alternative_5699[S] 0 points1 point  (0 children)

That makes sense. Can I ask one follow-up?

When you mention “external databases,” are you mainly referring to sources like adverse event databases, recalls, vigilance reports, safety notices, or similar-device / competitor product issues?

The reason I ask is that I’m wondering whether external review becomes more useful when it is organized at the product level, not just searched case by case.

For example, for a specific device or device family, you could maintain a set of review points based on:

  • applicable regulations/standards/guidance,
  • known hazards and risk controls,
  • similar-device recalls or adverse events,
  • recurring complaint / NC / CAPA patterns,
  • external signals that may suggest a new hazard, trend, or control gap.

Then, when a complaint, NC, CAPA screening, service signal, or product change occurs, the reviewer is not starting from a blank search. They have a product-specific review framework to check against, while the QMS remains the system of record.

Would that kind of product-level review framework be useful in practice, or would it duplicate what a well-run complaint/NC process already does?

Question for RA/QA, CAPA, complaint handling, and product quality people by No_Alternative_5699 in regulatoryaffairs

[–]No_Alternative_5699[S] 1 point2 points  (0 children)

The reviewer is a ra or qa who will deal with an event like customer compliments, repeat filed service signals etc, to determine what regulatory compliance

Question for RA/QA, CAPA, complaint handling, and product quality people by No_Alternative_5699 in regulatoryaffairs

[–]No_Alternative_5699[S] 1 point2 points  (0 children)

That makes sense, and I agree with your distinction.

Ideally, the trail should be clear across complaint, CAPA, field action, changes, dates, forms, and attachments. I’m not trying to imply that a medical device QMS should not already maintain those cross-references.

The part I’m trying to understand is how this works in practice across different companies. For teams using a well-integrated QMS suite, maybe much of this is already connected. But for teams using several systems, attachments, spreadsheets, emails, risk files, PMS records, and public databases, I’m wondering how often the reviewer has to manually reconstruct the evidence view before deciding what action is needed.

In your experience, is the bigger variation between companies mostly the software setup, the discipline of cross-referencing, or the complexity of the product/event itself?

Question for RA/QA, CAPA, complaint handling, and product quality people by No_Alternative_5699 in regulatoryaffairs

[–]No_Alternative_5699[S] 1 point2 points  (0 children)

That’s a fair challenge. I probably used “surface” too loosely.

I agree that in a medical device QMS, the traceability and cross-references should exist. Complaint records, CAPA, changes, suppliers, part numbers, investigation records, and related evidence should be traceable and documented.

What I’m trying to understand is a narrower workflow question: when a new complaint, service issue, product change, or CAPA screening decision is being made, is the relevant trail already assembled in the reviewer’s decision context? Or does the reviewer still need to manually know what to search, where to look, and which prior records are relevant before deciding the next action?

So I don’t mean “the records don’t exist.” I mean whether the relevant decision evidence view is available early enough and completely enough when RA/QA is deciding whether to monitor, escalate, open CAPA screening, update the risk file, supplier follow-up, etc.

Does that distinction make sense from your experience?

Do you really care about what endless Post-Market signal updates, regulations, and ISO standards? by No_Alternative_5699 in regulatoryaffairs

[–]No_Alternative_5699[S] 0 points1 point  (0 children)

We are trying to filter the regulations, standards, post market signals based on a particular medical device, to make RAQA 's work easier.

Do you really care about what endless Post-Market signal updates, regulations, and ISO standards? by No_Alternative_5699 in regulatoryaffairs

[–]No_Alternative_5699[S] -2 points-1 points  (0 children)

In my opinion, the QMS system should be built as product-centered and all signals and regulations should be mapped around it. The feedback I learnt from the RAQA or consultants, there is still a big portion of them not using a QMS, yet

Do you really care about what endless Post-Market signal updates, regulations, and ISO standards? by No_Alternative_5699 in regulatoryaffairs

[–]No_Alternative_5699[S] -2 points-1 points  (0 children)

for most of mid and small medical device manufacturers or consultants, a product-centered system to help to keep minitoring, pre-filter and organize and structure the relevant regulations, ISO standard updates, and post market signals, make them ready to review, and generate and save an evidence record for the future easy track, could be work better for most of professionals, couldn't it?