Is Data Integrity Essential?

Nowadays more than ever, the computerized age is gaining ground faster and the pharmaceutical industry has not been left behind. Reliance on computers and automated systems has increased drastically such that it has called attention to the efficacy, the quality as well as the safety of drugs and the general public health. At such a rate of incorporation of computerized systems, it has become a necessity for pharmaceuticals to undertake data integrity assessments routinely to ensure products produced are safe and do meet the market required quality standards.

Data Integrity Assessment
Needless to say, movement from the traditional paper data storage to the digital era has facilitated an immense amount of merits in terms of ease of access to data. However, it is important to note that such data should be of high integrity to avoid creating compromises. It is important to continually undertake a data integrity assessment for pharmaceuticals to ensure the utmost quality and compliance. As such, data integrity assessment allows for the execution of a high level of evaluation of pharma products to ensure strict adherence to data integrity as well as the guiding principles for data integrity. Such principles include:

• Attributable. A data integrity assessment ensures pharma data can be attributed to a reliable source and that should change be made on the data, they can be tracked accordingly.
• Ease of access and legibility. Data integrity assessment ensures the data can be accessed easily and can be read quite clearly should a need arise for the data to be accessed or to be referenced legally.
• The reliability of the data, as well as its accuracy, should be based on a recording as the data is being generated, observed or detection of a failure on the system. More so, the data should be routinely verifiable via a repetitive process of analysis and calculations and should provide similar results over and over
• Completeness, consistency, endurance, and availability are other aspects to which a data integrity assessment ensures quality and compliance of pharma products. As a guideline to comply with regulatory agencies and provide products of utmost quality, strict adherence to Good Manufacturing Practices (GMP) be it with pharmaceutical drugs, biotech or the medical devices companies is important. By assessing the integrity of data within the computerized systems in the pharmaceutical industry, gaps are clearly identified to which awareness is enhanced such that improvement strategies can be formulated to fill such gaps.

More so, it allows for the identification and the critical analysis of specific solutions such that eventually, solutions to be implemented can be of high relevance.

Data integrity assessment ensures focus is placed on the data integrity principles. In turn, such a focus ensures an understanding of a computerized system from a data integrity perspective regardless of whether a single or a high-level system identifying common loopholes on different systems giving rise to “general topic” The Pharmaceuticals field does mandate quality and compliance universally and as such, undertaking a data integrity assessment should be a routine practice as quality and compliance to GMP rules and regulations ensures the best of services are offered in meeting user needs and requirements.

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