Software implication in pharmaceutical production
How lives can be at risk and the implication of governments
I was talking with one of my coworkers. He was talking of one of his friend that works has a software developer for a company that develop products for drugs pills quality control in the pharmaceutical industry. He tells me that they had some problem with their production. They had many in deep bugs and architecture misconceptions. The result is the inefficacity of their product (we’ll call it: PhaQualCon) that lead to the apparition of false results. They have an abnormal level of false results; but the product is already used by pharmaceutical manufacturers. It seem a normal software development problem with normal consequences on the product. It’s possibly the problem of many technological projects (and probably all type of projects). My co-worker was saying that pharmaceutical companies have a threshold of false results not to exceed. The problem is that they can accept, refuse and remake some production tests to degrease their false results average. By this practice they can change some numbers to make them acceptable. So, this is not illegal in itself but I don’t think that this is really fair. I don’t know how the pharmaceutical industry work, but I can imagine that this is normal procedures and habits.
So the problem that I saw is not there. He is in the fact that these manufacturers rely on some type of quality control machines to know the average number of pills that are not conform to the specifications and then give these production test results to the government to make their production accepted. The machine not only counts this statistic but also discards or keeps pills. They rely on products such as PhaQualCon and they know that they aren’t trustable. Some manufacturers stopped their contract with the company but others don’t. Globally the production quality of drug pills relies on some piece of software that controls some type of hardware. The question is: What can stop pharmaceutical companies to pay the developer company of PhaQualCon to “add bugs” in their software to help them to have acceptable production quality tests accepted by the government? If they get cough, they have only to say that the problem is the result of a software bug and that this is not their fault. The company that develop PhaQualCon don’t seem to be supervised by some governmental agencies. They don’t have accounts to give to anybody. If their bad product is accepted by pharmaceutical manufacturer then he will be used to classify drugs pills for me and you. If such regulation exist and that the developer of PhaQualCon have accounts to give to some government, what ensure that the software have not been modified to adapt to the “exigencies” of the pharmaceutical manufacturer? If such a system (probably some type of certification) exists, will the certified system be reviewed monthly, quarterly, annually?
There are many questions on the subject. I think that this is our duties to ask them. Why? Because drugs can put lives of people at risks if drugs pills aren’t really exactly what they are supposed to be.