Is CSV implementation that important?
The author receives daily requests from pharmaceutical companies, medical device companies, vendor companies, and others for consulting on CSV (computerized system validation) implementation.
In many cases, the reason given is simply that regulatory requirements must be complied with, for example, to prepare for regulatory inspections or to avoid being pointed out in customer audits.
It is the so-called blind compliance situation.
However. In the first place, the purpose of healthcare-related regulatory requirements is to guarantee patient safety, assure product quality, and guarantee product efficacy.
It is a complete set of CSV documents for the purpose of inspection (documentation for the purpose of inspection), which is not the end of the story.
Where in the world are they working?
The purpose of CSV implementation is not to respond to inspections. Often the purpose and means are reversed.
CSV is imposed when a computer system is used in a process subject to regulation.
However, computer systems have an indirect impact on meeting the requirements of predicate rules (GLP, GCP, GMP, GVP, GQP, GPSP, etc.).
Since it does not directly affect patient safety, product quality, or product efficacy, CSV implementation is not of paramount importance.
To implement CSV, companies spend compliance costs.
However, the costs used by the companies are not paid for by the companies themselves, but are passed on to the drug or product prices.
In other words, it is the patient’s responsibility.
Therefore, it is not acceptable to spend any amount of money on compliance costs.
To put it a little more bluntly, the medical care would only be able to save the high income earners.
We should not blindly implement CSV and spend compliance costs because of regulatory requirements or because of inspections.
First, it should be determined to what extent the computer system in question affects patient safety, product quality, and product efficacy.
It is the so-called risk-based approach.
In particular, Japanese companies tend to want to establish uniform standards in advance. However, in the risk-based approach, there are no standards to begin with.
The validation of each computer system should be based on the degree to which it affects patient safety, product quality, and product effectiveness.
Whenever there is an inquiry regarding CSV implementation, the author always asks what kind of product it is and which business area (non-clinical, clinical, CMC, manufacturing, post-marketing safety management, etc.).
The reason for this is that different products have different risks, and different processes have different risks.
For example, the risk would be high for sterile drugs, anticancer drugs, psychotropic drugs, blood products, and vaccines.
On the other hand, gastrointestinal medications and nutritional supplements would be less risky.
Company personnel are more likely than regulatory inspectors to have a higher level of knowledge of the product in question than the inspectors.professionalThe first is.
They should also be familiar with what risks are latent in each process and to what degree.
I urge you to We hope you will aim for a professional activity.
Creating CSV procedures and forms that anyone can do is nonsense.
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