The importance of data integrity is a widely discussed issue. There has been a rise in regulatory bodies like the FDA and WHO auditors focusing specifically on this issue, ensuring better training of their staff to spot any breaches quickly and reliably.
With this rise of focus also comes an increase in complexity and difficulty for companies to maintain data integrity. This article will examine why it matters, why validation is important, and what you can do about it.
The Importance of Data Integrity in the Pharmaceutical World
Data integrity in the pharmaceutical industry refers to maintaining and proving the accuracy and consistency of any data collected over the lifetime of a pharmaceutical product. Any system in which data is used, stored, or accessed must have data integrity concerns as a key part of its setup. Integrity is utterly central to drug development, clinical trials, eventual manufacturing, and long-lasting regulatory compliance. It ensures accurate and consistent records, regardless of any changes made during the product’s life cycle.
Data integrity solutions can help pharmaceutical companies in a few ways:
Compliance
Regulation bodies require the production of data that has provable integrity and covers all aspects of the product life cycle. If you cannot provide solid evidence and data for your product or there are gaps in your information, your product is unlikely to be approved.
With such key policies in place, pharmaceutical companies can adhere to principles such as ALCOA+ and regulations such as the FDA’s 21 CFR Part 11 and the EU GMP Annex 11.
Product Quality
Ensuring the integrity of the data connected with every stage of a pharmaceutical product will help prove the product’s quality. Each stage of the innovation and trial process should be documented clearly, including results and quality assurance measures that have been taken at various stages. This can go a long way to establishing trust with regulators and end-users. Without this, there is no way to prove that your product is safe and of high quality.
Business Functions
The data produced in the creation and testing of products or even across studies undertaken is vital to the running of a pharmaceutical business. Implementing policies and procedures to manage the integrity of this data ensures that it is accurate for business decisions. By accepting the use of digital data and controls around its integrity, companies can make faster and more accurate decisions. For instance, reusing research towards the creation of more products at a later date.
Collaboration with other companies, pharmaceutical bodies, or educational bodies will also be streamlined and more effective when knowledge or technology is transferred if data integrity has been carefully maintained.
What if it is Not Maintained?
Whether the data integrity failure is deliberate or accidental, there could be a substantial impact on the company. This could range from receiving a warning letter from the FDA to revoking their pharmaceutical license.
It is highly likely that its share price will drop, affecting stakeholders, and the negative publicity surrounding the incident will result in a drop in customer trust and a negative reputation, which will be very hard to shift.
If products manage to get through to end users without quality or product assurance, then the results to the customer could be severe, putting their health and safety at risk.
The Role of Validation Tools in Data Integrity
Data is the key source of information allowing to state if assets operate in a validated state. Discrepancies, missing values, and any other errors will be highlighted so that they can be investigated and corrected.
By using expert tools, companies can produce more accurate data analyses, saving time and money. As always, precise data analysis can provide insights and growth opportunities for a business that might otherwise be missed. However, these will only be beneficial if the data is correct. Knowing the data is accurate can help with moving forward in the modern world, too. Machine Learning algorithms are gaining traction and improving in output very quickly, but they are only as good as the data that is put into them.
However, the most important role of data validation is ensuring that companies remain compliant with regulations and industry standards.
There are many different checks that can be performed, including the data type, coding, formatting, uniqueness, and consistency. These all ensure that the data is accurate and consistent, with nothing missing. By looking into digitisation tools for data validation, companies can reduce the risk of data integrity breaches and streamline the process, becoming more efficient in a fast-paced industry.
Problems with Data Integrity within Validation
Ensuring data integrity through validation is becoming harder. Requirements from regulatory bodies have not been changed, but the amount of data sources we now have and the amount of data produced is at levels higher than ever before. Pulling data from multiple systems and sources, constantly changing data, and unstructured data can all create a confusing network of information that needs to be double-checked for accuracy. The amount of time and resources required to check through everything is constantly increasing.
The rise in data privacy and digital security concerns has also made validation harder. Special precautions will likely need to be implemented when dealing with private information during the validation process. Privacy will also need to be considered at the start of gathering the data to protect information while maintaining data accuracy and completeness. Data anonymisation is one way to get around this. With data security, access to secure information is restricted, possibly causing blocks in the validation process. However, ensuring that there have been no external breaches is also a key data integrity check.
The rising use of machine learning, AI, the blockchain, and cloud computing technologies has made validation harder for companies. They have complicated the data network, including having more access points from multiple sources. This increase in complexity has increased the level of validation needed, with companies finding it much harder to keep up and stay compliant.
To help, the International Society for Pharmaceutical Engineering (ISPE) released the Baseline Guide Volume 8: Pharma 4.0 1st Edition with tips for companies trying to balance efficiency with the level of work needed.
The Solution
Digitisation of validation tools can go a long way toward reducing the time and cost needed to spend on the process. Time spent manually on intensive, bureaucratic, long-winded tasks can be reallocated by shifting to an automatic program, allowing companies to manage resources more effectively. Large global organisations can coordinate and systemise their validation processes, ensuring consistency across countries, let alone departments. Digital validation processes happen in real time, so responses to errors can be immediate, and the resulting analysis can be used for more informed decision-making.
Rephine understands how important data integrity is to pharmaceutical companies
We can help you in the implementation and validation of ValGenesis VLMS® to help streamline your validation processes, ensuring that your resources are used effectively while staying fully compliant, as our expert team is up to date with the latest regulatory bodies’ guidelines and requirements.
We support you in the digitalisation of your validation, either implementing your VLMS solution, or providing you with our own VLMS preconfigured platform, which you can use on your own digital implementations and validations.
