Data Integrity Survey Results
We had conducted a data integrity
survey that has amazing results. 3360 visitors of pharmaguideline.com
participated in this data integrity survey and 87 % them were from India..
There were 8 simple questions regarding data integrity. Questions had options
to select and all were mandatory to answer. These are the results and their
interpretation.
Q1. Does your company have Standard
Operating Procedure for data backup and deletion for
HPLC/GC/UV-Spectrophotometer etc.?
29% of pharmaceutical companies
don't have an SOP for the data backup of instruments like HPLC, GC and UV
spectrophotometer.
It means about one third
pharmaceutical companies don't have care about data of the important analytical
instruments.
Q2. Does your company have the
procedure to review data integrity?
23% of pharmaceutical companies
don't have a procedure to review the data integrity. Without any procedure, how
these companies can implement data integrity, its a big question. This figure
shows that only 77% of companies have implemented the data integrity and 21 CFR
part 211 guidelines.
Q3. Do you know the requirements of
21CFR compliance?
This question was asked in addition
to the last one. 21% of employees of the pharmaceutical are not aware of the
requirements of the 21 CFR compliances. It ensures that more than 20% of
companies have not implemented the data integrity procedures.
Q4. Do the employees in your company
share user IDs for GC/HPLC/FTIR/UV instruments?
User IDs of analytical instruments
are shared by the employees of 30% of pharmaceutical companies. Sharing user
IDs during analysis is a serious data integrity violation but analysts of these
companies share login credentials for the analytical instruments.
Q5. Does your company have any
system to report the quality issues anonymously?
Some companies have a system to
report the data integrity issues by the personnel without sharing their
identity. But 38% of companies don't have implemented this system. It is not
mandatory to have such a system but it can help to improve the data integrity
in pharmaceutical companies.
Q6. Who has the administrator rights
of the instruments like HPLC and GC?
The person having administrator
rights of any computer or software can change or delete the data or change the
date of the computer system.
Analysts having administrator rights
can analyze the sample in any that is the biggest data integrity violation. 14%
of analysts and 35% of lab incharge have administrator rights that are not good
for a fair analysis. In 51% of companies, the IT personnel have administrator
rights of the computers used in the analysis. It shows only 51 % of companies
are following the right procedure for administrator rights.
Q7. Does your company have an
efficient and qualified manpower?
When we asked this question, 10%
responders admitted that their company doesn't have the efficient and qualified
manpower. It means 10% of pharmaceutical companies are running without
qualified personnel.
Q8. Does your company have data
integrity issues that can be found in a regulatory inspection?
This question describes the overall
condition of data integrity in pharmaceutical companies. 51% of survey
responders admitted that their company has data integrity issues and these
issues could be found in regulatory audits. It means more than half of
companies have data integrity issues.
Results of this survey show that a
lot of pharmaceutical industries are not serious about data integrity. A lot of
data integrity issues are there in pharmaceutical manufacturing facilities. It
is required to focus on these issues to manufacture the quality products that
would be safe for the patients.