We know the available elements of ALCOA. We will discuss
latter on the ALCOA topic. But currently we want to emphasis on the issue why
we are getting this issues? Data integrity no only the problem of a specific organization,
reflects how country are acting on the integrity issue. It will give very bad
impact on the overall pharmaceutical industry in India and it will reduce the confidence
level in different regulatory bodies.
Once again we need to work together to remove this issues
from our country. If we classify why this type of problems then we will get
following points,
- Shop floor people Awareness: It can be resolve by providing training
- Doing mistake by mistake (unknowingly): Repeated training and awareness program
- Doing mistake knowingly: It’s will be consider as a criminal offense.
- Lack of resources: This also a contributory factor for data integrity. e.g. man power also consider as resource which is a critical factor for integrity.
- Pressure of productivity on Quality: This is the management polity, manage need to be think on that strategy. Quality should have definite freedom to take flexible decision/action on any deviations.
