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The pharmaceutical industry has long been in the public eye. People all over the world rely on quality medicines, medicines that are safe to use and above all, that are effective in curing diseases to cure them.
However, due to human error or sometimes lack of ethics, some manufacturers do not meet these requirements. As a result, patients waste their resources on treatments that are ineffective and may cause more harm than good.
In fact, there are various regulatory guidelines on data integrity to monitor the conduct of organizations and manufacturers in producing quality medicines before they reach the market. National regulatory authorities collect information that should be accurate and complete so that the public can have confidence in manufacturing products.
Recently, there has been a lack of integrity, especially in the lapping of computerized systems. However, with certain regulatory guidelines and standard sets, data integrity is essential to compliance. Below are some of these guidelines.
Part 11 of Title 21 of the CFR is a widely used document for appropriate data management. This applies to electronic records with signatures. This section is divided into three subsections. The General Provisions section gives a brief overview of all terminology used in the document and all record types included and records that are not applicable.
The second part, the Electronic Records section emphasizes the need for signatures on records. It also states that computerized systems must be effective to ensure accuracy, reliability and consistency of data input and processing. Access to these systems should be restricted through IDs and passcodes. Personnel must be trained and experienced in using computerized systems to ensure data security and integrity.
The third section emphasizes controls such as electronic signatures and periodic password changes.
FDA uses an acronym, ALCOA, which stands for ‘attributable, legible, contemporary, original and accurate’ to show the direct impact of data quality on product quality.
Compliance with FDA data integrity and cGMP guidelines is to explain the function of data protection and integrity in good manufacturing practices. The idea is to increase production of good quality drugs by manufacturers. As mentioned earlier, the data should be 100% accurate and can be relied upon. It should be consistent with the actual practice of an organization. However, this is draft guidance so not a requirement that must be followed.
In the United Kingdom the MHRA GxP document is a guide to quality control of medicines through data integrity. It emphasizes that, for manufacturers to provide the best quality of medicines, data integrity is fundamental.
Ethical behavior is mandatory for all professionals. Adequate safeguards are provided to reduce the likelihood of unethical behavior by manufacturers. For example, data manipulation should be completely prohibited. Generated passwords should be strong and made available only to personnel who have appropriate authority on the system.
Everyone is responsible for data security and integrity Inspectors sent by national regulatory authorities do not make allowances for lack of data integrity to maintain manufacturers’ best interests at the expense of patients’ well-being. These guidelines must be followed strictly.
