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Krishnendu Singha
Manager – Quality Assurance
[The author is a Quality Assurance professional of a leading MNC]

DI issues – a cause or effect
“It is only the laboratory where such issues were noted, otherwise, we were good at everything”- heard almost after every USFDA inspection once a 483 or warning letter has been issued. It’s been always the laboratories accused of objectionable GMP findings specifically related to data integrity issues.

The question that remains unanswered is why would someone from one department of a big organization be so unethical, so unprofessional that they tend to cause such damages to their own organization who they receive salaries from? In fact, they had to work hard to earn this job! Neither are the lab professionals happy to have damaged organizational reputations. We perhaps may need to rethink whether we are blaming the corners for holding dust of a big room. It might turn out that we start realizing integrity issues are actually the consequence of an organizational deficiency and a reflection of an operational integrity; it has less to do with data and more to do with integrity. Data integrity non-compliance therefore is not the cause but a real effect.


External training is great but…
“We have called a most leading Pharma consultant group to come to our plant and train our people to enhance their knowledge on data integrity…” responded an affected company to a regulatory agency audit observation.

It is absolutely important to learn the most modern and emerging concepts from the consultants but it is noticed for many organizations that they arrange external training for their down-the-line doers, but the top management keeps them away. Almost all the data integrity related trainings need involvement of the top first as trainers say “it starts from the top”, but low engagement does not warranty a successful deliberation. The fact for most of the cases is that training is more a show-off work in either to demonstrate action against certain deficiencies or, to complete a pre-planned training schedule or even, to spend the budget allocated for trainings. The content, application and objective of training thereby is always ignored.

Sense transfer – the greatest of corporate traditions as ever!!
The most popular internal corrective and preventive action method indeed is sense transfer. Many organizations claim to be highly committed to Quality and Patients. They often show a critically concerned face in a board meeting, a serious voice and a ‘zero tolerance’ gesture while communicating concerns to the down streams. The serious faced managers and supervisors take on doers heavily without giving any solution. “If anyone is found to do this, we will do that” is one of the most common mandates heard so often from the supervisors to the doers. These fatwas are most commonly perceived to be the effective stands taken by the management because of ego satisfying senses that get transferred from the top to the bottom. Let’s check what happens as a result of sense transfer. The doers, including best performer, can suffer of fear of a possible failure. Such fear of failure leads to more errors. And to avoid unpleasant consequences the doer starts figuring out ‘short-cuts’ which only adds to the problems instead of resolving them.


It is not the human condition but the working condition where human work…
I have asked many individuals why data integrity issues are so much prevalent in the industry. Most of them pointed out to many aspects such as culture, lack of guidance, lack of automation, manipulative tendencies, lack of monitoring etc. When the same question was asked in a different way: “What does not create data integrity issues?” some interesting simple facts got revealed. Unanimously, the response is that, if a performer is delighted to perform the work, has adequate time to perform the task, has adequate knowledge and expertise, and the method is robust and stable, and if environment is empathic, there would never occur data issues whatsoever. This explains what should be done at the first place. Most of the people say, unplanned supply urgencies sometime is the cause of laboratory hurries and worries. Some say, most methods are tricky at times; those methods are not well developed (though validated as documented). When it comes to expertise, most people understand what they need to do when everything goes perfect but, most of them do not know what exactly needs to be done if something goes wrong. Almost all say, error is not allowed, repeat analysis is too costly for a laboratory. In fact, scientifically, error and mistake are not synonymous. Error is part of analysis. The first chapter of any book of analytical science is error. Error is obvious; mistakes should be only taken care of. Errors and mistakes should be distinctly understood and addressed empathically. Most analysts in a lab are most and probably only afraid of failure. Humiliating consequences to a failure (the sense transfer) either makes analysts lose confidence or they become too smart. Problem begins from here. There are several other reasons. Perhaps, these are the real root causes requiring urgent attention.

Do automations have all the answers…..?
The current focus has shifted a lot towards having secured data management laboratory software programs. Most of these programmed softwares are able to restrict deviations as well as to capture real steps taken by analysts. Automated audit trails and interfaced synced lab documentation templates such as LIMS, LES are good advancement of technology which helps to determine quality and reliability of data. These softwares improve visibility of a performance but do not mitigate the real causes. Let’s take this example. Lab softwares cannot prevent manipulation if an analyst chooses to manipulate test for content uniformity by filling sample solutions from four flasks instead of ten, to ten HPLC vials in fear of a failure. Time should be spent as much as possible to understand and mitigate the fear, not in developing ability to catch the thief. The method, priorities, knowledge should first be worked out before relying on softwares. Let automated softwares then present the most trusted performance. 

The Big Picture
No matter how much big the risk looks like, there is no doubt that a big opportunity is lying ahead of us, to transform organizations into ‘better’ organizations of tomorrow. It is no time for worrying, rather a time to be thankful of the issues. It is time to introspect and fine-tune all internal tools and machineries to synthesize a more value driven organization. Data issues bring quality and process more closely to each other by shifting paradigm from building process for quality to building quality into process; efficiency and compliance will thereby go hand in hand…..and customers will follow.



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