Data Integrity and Indian Pharma
Data integrity has become a major concern for the pharmaceutical industry, due to the increased vigilance of regulatory bodies such as the FDA, the MHRA, and the WHO. When we refer to ‘failure of data integrity’, what we mean is the corruption of data culled by an organisation.
A simple overview of all 483 forms issued in the year 2017 indicates that the majority of these observations are related to the human error when it comes to data integrity compliance (Figure 1).
The work culture in any medical laboratory is the most vital and least discussed factor in maintaining data quality. All these errors can be subdivided into the following three categories:
- Mistakes may have happened inadvertently.
- Mistakes may have occurred due to lack of knowledge.
- Mistakes may have been performed deliberately.
There are also various factors that could lead to substandard levels, which are in-turn being touted as the violation of the GMP regulations. Some of these important factors are:
The casual approach and laid-back attitude of the employees
The importance of their jobs must be clearly understood by the employees. In return they will pay more attention and carry out their responsibilities with care, caution and with the necessary attention to detail.
The volumes of ‘tasks allotted’ and the ‘pressures exerted’
Managers must always bear the strengths and weaknesses of the individuals in mind while assigning responsibilities.
Manager and employee’s relationship
Managers should always propagate a positive attitude and healthier working atmosphere for the smooth and honest running of any company.
Fear
Fear is an overriding human reason for the suppression or manipulation of data. The same fear then causes the prevention of acknowledgment of any mistakes and negates the possibility of preventing further compliance issues.
All said and done, the attitudes of your employees plays a crucial role in maintaining the quality and ethics of the organisation. Whether for better or for worse, employee attitudes tend to have a drastic impact on the quality and productivity of an organisation. The employees must be well trained and awareness programs must be conducted to make them aware about all requisite information such as:
- What is data integrity and why is it important.
- The role of every employee towards maintaining the data integrity.
- The methods and systems to be followed to ensure the integrity of data
maintenance. - The complications and costs of the audit failures to the company.
The implementation of automated systems might be helpful in mitigating few of the risks concerned with alteration and deletion of the data. But, unless the mindset of the people on the floor changes, the proportion of the observations coupled with human errors will never be brought to zero. And herein lies the biggest issue faced when it comes to data integrity compliance today.
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