Regulatory Guidelines on Data Integrity : Pharmaceutical Guidelines

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Regulatory Guidelines on Data Integrity

All regulatory agencies force pharmaceutical companies to manufacture best quality products. Therefore they have their guidelines for data integrity to maintain and secure records.
The pharmaceutical industry has been on the public eye for a long time now. People all over the world depend on quality medicine, safe to use drugs and above all, those that are effective in curing the disease they are meant to cure.

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 bring more harm than good.

In effect, there have been different regulatory guidelines on Data Integrity to monitor the Institutions and manufacturers' behavior in regards to producing quality medicine before it reaches the market. The national regulatory authorities collect data that should be accurate and complete to determine the trust the public can put on the manufactures products.


Recently, there have been integrity deficiencies especially on lapsing computerized systems. However, through some regulatory guidelines and standards set, data integrity is essential to becoming compliant. Below are some of these guidelines.
Related: Importance of Data Integrity in Pharmaceuticals

Part 11 of Title 21 of CFR is a document widely used for appropriate data management. It applies to electronic records, including signatures. This section is divided into three subparts. The General Provisions section gives a brief view of all terminology used in the document, and all the record types that are included in it and those records that do not apply.

The second part, the Electronic Records section emphasizes the need for signatures on records. It also states that computerized systems must be effective in ensuring accuracy, reliability and consistency of the data input and processed. Access to these systems should be restricted through ID and passcodes. Using computerized systems requires staff to be trained and experienced so as to ensure data security and integrity.

The third part is on the emphasis of electronic signatures and control such as periodic password changes.

The FDA uses an acronym, ALCOA, meaning 'Attributable, Legible, Contemporaneous, Original and Accurate to show the direct impact of data quality on product quality.

The FDA Data Integrity and Compliance with cGMP guideline are to explain the work of data security and integrity in good manufacturing practice. The idea is to enhance the production of good quality medicine by manufacturers. As stated earlier, data should be 100% accurate and can be relied on. It should be consistent with the true practices of an institution. It is, however, draft guidance hence not a requirement that must be followed.
Related: FDA’s Top Data Integrity Issues Found During Inspections

The MHRA GxP document in the United Kingdom is a guidance provided to regulate the quality of medicines through data integrity. It emphasizes that, for manufacturers to provide the best quality of medicine to its, data integrity is fundamental.

Ethical behavior is mandatory for all professionals. Appropriate safeguards are given to reduce the chances of manufacturers lacking ethical behavior. For example, manipulation of data should be completely prohibited. Passwords created should be strong and should only be made available to staff that has proper authority on the systems.

Everyone is responsible for Data security and integrity. Inspectors sent by National Regulating Authorities do not give allowance for lack of Data integrity to maintain manufacturers' best interest at the expense of patients' good health. These guidelines are to be adhered to strictly.





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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3 comments: Post Yours! Read Comment Policy ▼

  1. Good morning sir,This is chinnammalu.why we perform Assay duplicates in Pharma.

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  2. How we can minimize analytics error in duplicate

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