Data Integrity by Raman Mehta

Pharmaceutical and Biopharmaceutical industries must develop the strategies to eliminate the Data Integrity from their Organizations. However, the biggest problem is that the Organization are bounded with multiple myths which stops them to come out of the issues pertaining to data Integrity. Five biggest myths which are hindering in the process of improvement are:

Our Organization is Not having Data Integrity Issues

Organization generally believes that they are not corrupted by this syndrome. However this is the biggest myth ever. Data Integrity is not always personnel driven, however it can be due to the poor systems and poor technology. Use of traditional systematic controls and obsolete technology may lead to be inherited issues in data integrity which may or may not be identified. It is therefore utmost important to identify the scope of improvement is every aspects, which includes (but not limited to),

  • Use of updated Technology & Equipment
  • Use of Electronic Data management System
  • Data should be managed/replicated electronically through validated system through its life cycle.
  • Digitalization & automation must be preferred when data recording is required.

Today’s Adjustment – Tomorrow’s Culture!

Data Integrity issues cannot be disclosed or reported

Be Open! Being a Subordinate or Being a Manager Always be Open!

You can discuss every sort of mistakes in an environment where you are open and free from any mental fear.

No regulator believes that any organization is free of the Data Integrity Issues; however, data manipulation is violation which is not acceptable at all.

Data Integrity issues cannot be eliminated

You can! Time can fulfill all impossible tasks. Only thing you need to do is keep going and believing that it is possible. It’s not a one day job although it is a continuous system. You need to update all components required for the same:

  • Personnel – Understanding about ALCOA+ etc.
  • System and Technology – Use of Technology and Automation of tasks / Operations etc.
  • Use of systematic and procedural controls – Restriction of user rights etc.
  • Adequate Quality System .

More Documents doesn’t means a better Quality System

Cost is required to ensures Data Integrity

A cup of Coffee even costs something, so how can such a great task be achieved free. But it should not be represented like a ghost as we are told in grandma stories.

  • It is a continuous process and as discussed earlier try to adopt the following basic steps:
  • Automate – wherever possible,
  • Digitalize – for better accuracy
  • Prefer Systematic Controls – Over manual control
  • Develop Open Culture – Be Ready to accept Change with Time

Data Integrity is Personnel Driven

5M Tool teaches us that Man can be the One of the Root Cause of any failure. However there is not any task which can be accomplished without Man. Therefore in any failure you can pinpoint Man a Root cause every time if you wish to do so. This is not justifiable, we need to go beyond and identify the further reasons to understand the real reasons behind the Data Integrity.

Think Beyond “You”!

Conclusion         

It is important we come out of the myths about Data Integrity. Data Integrity issues can be eliminated and it’s a organizational objective not an individual objective. Data Integrity implementation is always a continuous process and do-able always.


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