The concern around data integrity at most companies – not only on the ones based out of India – is intermingled with the cultural background of personnel on the shop floor, lack of awareness on the regulations around data security, and finally, a lack of design control to prevent such issues. In geographies with monarchial legacy, people are used to following orders without questioning if they are right. In countries where the personnel come from this lineage, the cultural values dictate that saying ‘no’ to their manager is considered disrespectful, and hence such companies thrive on the value system of the leader. Hence, there is a real concern in companies that culturally fit the description above, and where management choose to cut corners to achieve business goals. In addition, some of these companies have low tolerance for people that voice their concerns, and that prevents employees from owning up to errors and resorting to data manipulation to save their jobs.

Let us look at some other practices – all of us who have studied in the eastern world can relate to some of the practices followed by us when we were in school. There is a rough book and then there is a fair copy. During live lectures, notes are taken in a rough book as it may have corrections and mistakes. The notes are then copied again in the fair book excluding the mistakes such that the fair copy is clean. The fair copy is submitted for endorsement by the teacher and grades are allocated for neatness. Employees who grew up with this concept struggle with concomitant recording and they write on a sheet of paper or back side of label etc., and then later transcribe onto a batch record. The intent at times is not to change the data but to enter the data ‘neatly’; however this is not acceptable within the ALCOA principles.

In certain countries, there is a trend of asking one’s team member to do one’s own work by delegation. This goes to the extent of delegating authority to use one’s password at workplace without knowing the implication of this act. Managers reveal their password to their juniors to perform electronic reviews and approval. The realization that this is the equivalent of giving someone else the authority to sign your bank checks comes in much later. The fact is that your password stands for your signature and is legally binding and represents ‘you’- any issues that come up will need to be hence addressed by ‘you’. Language barrier add an additional layer of complexity to the data integrity situation. English not being the native language, employees are sometimes not eloquent enough to address questions to the satisfaction of the regulatory inspector.

Several instances of data integrity concerns reported globally have similar causes. Let us look at a few:

1. Lack of willingness to spend on compliance needs. Eventually, ends up spending ten times the amount to hire international consultants for remediation once the firm is in data integrity turmoil.
2. Resource constraints leading to inadequate staffing in quality divisions.
3. Lack of independence of quality division. Many firms have their quality control reporting into operations. Quality control is the final safety net for the product before it steps out and most patient safety decisions by QA are based on the data that QC generates.
4. Quality is the responsibility of Quality function and not a company-wide culture.
5. Lack of top management commitment to quality.
6. Lack of interest from the leadership on regulatory inspections, its readiness and its outcome.
7. Quality function is pushed to take decisions in favor of meeting business numbers instead of compliance.
8. Quality is not a collective responsibility in the organization.
9. Not spending in hiring a competent quality team. Your quality leaders must understand regulations well as they will interpret and execute the standards as expected.
10. Build lots of circles of policing and reviews rather than invest in building a culture of compliance and integrity.
11. Common culture of backdating like meeting agenda, meeting minutes, circulars, secretarial papers etc slowly seeps into the company’s culture and eventually into quality system documents as well.
12. Low spend on electronic system and automation, which are key to real time recording and data integrity.
13. Low tolerance to accept shop floor errors.

Our research has shown that firms that run into issues of warning letter and import bans weaken their brand, lose investor and customer confidence, and hence take a significant hit to their market share and revenues. It also takes a long time (if at all) to regain the trust that is lost, with investors, customers and regulators. It is our view that companies look at their internal structures, systems, people and culture to address the issues above. The time spent is worth the benefit that can be achieved.