KNOW YOUR SYSTEMS

Engineering control is the best solution forever to overcome frequently happening errors, design your systems / equipments/ instruments such a way that operating people cannot do false actions by mistake or even deliberately. Nowadays many modern systems are available in market with inbuilt controls, or you also can design and build your systems as per your requirements. We should start our consideration of basic controls by agreeing on a fundamental guiding principle that procedural controls are never enough. Where humans are involved, mistakes will happen. Some of the companies are still using legacy systems, software, they should perform risk assessment proactively and necessary changes shall be initiated based on the outcome of risk assessment.

Qualify / validate your systems as per guideline requirements, this activity can be get done by subject matter experts/ third party consultants. They can add value of their knowledge to qualify the system and save your system from future data integrity breaches.

KNOW YOUR PROCEDURES

Being an owner of process/ procedures being carried out at your organisation, you must have control on procedures and process, complete understanding of process will help you to enforce procedural/ administrative controls, wherever engineering controls are not possible at all.

Known critical process parameters and critical quality attributes can be illustrated more explicitly to the team members who are involve in the actual operations and prone to do mistakes.

KNOW YOUR DOCUMENTS/ RECORDS

Prepare your documents to be user friendly, document executer shall be able to record entries easily, steps involve in the data entry shall be logical and sequential. Try to include notes/ instructions in bold, it will help to minimize mistakes to be happened by the executor, eventually an error free data will be recorded in the document.

KNOW YOUR WORKPLACE

Being a team leader, it is inevitable to be more vigilant about the work culture at your workplace, you must ensure that your team members are not working in stress of workload, pressure from seniors/ supervisors. Working ambience should be pleasant. Workplace should be easily manageable, apparatus and tools/tackles, materials/reagents must be easily available. Ensure that one person has not been assigned for two different tasks simultaneously. Insist that Logs, instructions, SOP/ STPs, documents for recording are always available with the person who is executing the task.

KNOW YOUR POLICIES

Define your policies with clearer objectives and expectations, explain the policies to your teams and encourage them to follow it voluntarily people will truthfully follow it. Policy should explain that everybody has freedom to ‘say no’ for unethical work and everybody has right to highlight unethical work practice to apex management straight forward.

KNOW YOUR PEOPLE

Based on the trends of observations, related to data integrity observations; most of the incidents related to data integrity happens due to human errors. Human error can be arising unintentionally or purposefully, error can lead to critical data integrity observation. Understanding behaviour of your subordinate is very important. Person who is performing activity assigned to him/her, must be trained and well aware about the role. They should be handy to handle critical activities without any pressure and any unintentional error.

Assigning the responsibility / work after assessment of ability and area of interest, can be good solution to minimize frequently happening mistakes. Make sure that your information technology assets are clearly identified and labelled (i.e., company asset tags and the like), have strong user-based security (e.g., system passwords and media encryption), and users are trained in security awareness, not just when they are hired but throughout their employment.

Many people ask with exasperation how it is possible to control all the people all the time? But now a days many software are available in the market complying to the all regulatory agencies expectations. Prevention of nefarious act is difficult, but it is typically accomplished through basic security controls, where the robustness of such controls is commensurate with risk.

Now a days many companies have their multilocation units globally, their man force working from different locations on single project software, it is very likely to happen the mistakes inadvertently or one can do it deliberately, to avoid these things happens even with malicious intent, appropriately designed security access to a collaborative, cloud-based space allowed for a prevention of disaster and a recovery of the deleted files is the most effective and proven control.

By following all above control measures proactively, you can save your organization to be cited with data integrity observations by regulatory authorities.