Pharma Warehouse Management

1. How Can Pharma Companies Avoid Data Integrity Issues?

2. Did you know that 65% of warning letters issued by the FDA cited data integrity problems in 2021? That is a massive spike from 2020, where 51% of the 483s cited data integrity as a problem. Data integrity is a critical topic in pharma manufacturing. Despite the FDA’s ‘set-in-stone’ guidelines, we see numerous 483s citing data integrity as an issue each year. And this problem exists globally. What is data integrity? Data integrity is the practice of maintaining and ensuring the accuracy of data consistently during the manufacturing of a product. All records during the manufacturing process need to be validated as per FDA’s guidelines. Any change to the data without reflecting in the records is considered a failure of data integrity. It involves ensuring which user created and saved a record along with date and timestamps and that all data is accurate, consistent, and complete, making it reliable and trustworthy. It is important to note that FDA has not made any changes to the definitions or regulations or expectations in recent years. There have not been any new guidelines or regulations in the category. This clearly indicates that the companies have not been able to implement the requirements satisfactorily.

3. To ensure data integrity, pharma manufacturers need to ensure all data meets the guidelines outlined in the ALCOA acronym: Attributable – All information about the person collecting the data, the origin of the data, and the timestamp of data collection. Legible – Data should be easy to read. Contemporaneous – All data must be recorded as and when the activity is done. Original – The original data records need to be preserved throughout their life cycle and be long-lasting. Accurate – Data needs to be error-free and high quality, with all changes being reflected in the supporting documentation. Why data integrity issues still persist… There are commonalities in the data integrity issues cited in warning letters over the years: incomplete production record data, incomplete lab data, and deficient access control regularly top the list of the most common data integrity observations.

4. In most cases, issues with data integrity reflect the company culture and mindset towards following best practices, automation, importance of maintaining authentic records and quality. Lack of a data integrity assurance strategy One of the biggest reasons for failure to comply with data integrity guidelines is that there is an abundance of data which makes it challenging to maintain quality across the board. But there is a way this data in pharma manufacturing can be managed? How to avoid data integrity issues The reason why the FDA has such stringent data integrity regulations is that pharmaceutical products have an impact on public health. It is imperative that all products marketed to the public are safe to consume and effective. Data integrity plays a crucial role in ensuring that.

5. Make Data Integrity a Part of Your Company Culture Once we understand why data integrity is so critical, it becomes easier for business owners to ensure their teams are aligned with the values. Quality must become a part of every process, and every phase of pharma manufacturing, from sourcing raw materials to the point the product reaches the consumers. And the best way to ensure quality is by ensuring data integrity across the product’s journey. Achieving data integrity compliance involves a cultural change throughout the company, which originates at the top and needs to be a continuous process. Set up a Robust Data Integrity Strategy The first step for any company is to assess its current systems and processes to understand the problem areas. Assess the compliance status of your existing systems and the scope of your company’s data integrity efforts. Lack of clarity in any organization area commonly leads to data integrity issues. Next, the company must create a strategic plan to tackle the problem areas. Tackling your data integrity issues head-on will create proper data management best practices and data integrity compliance. Digitization helps reduce human intervention and sets in place a do-er and checker system, thus reducing errors.

6. The FDA has laid out clear guidelines delineating expectations from pharma companies. How the guidelines are to be met is usually a company’s decision. The companies use their own understanding of the regulations to set up systems. Some might even be convinced that data integrity can be maintained using traditional methods. It is widely observed that companies that still follow archaic means of managing data find it extremely difficult to meet the data integrity guidelines. Manual systems to capture, store and utilize data require human intervention and can even be accessed by anyone and altered. Automate Shopfloor and Warehouse Processes Automation of warehousing and manufacturing processes allows you to set up SOPs that guarantee compliance with 21 CFR Part 11. It does not leave compliance to chance, forcing personnel to abide by the regulations at each step. Not only does this simplify the work and make your system more efficient but it also ensures a favorable outcome in case of an audit. In addition, automation by default generates a lot of data that can be used to derive insights and create reports. In the long run, this allows businesses to make data-driven decisions to achieve favorable business outcomes.

7. It also enables you to be audit-ready with the help of tools that allow the electronic capturing of data and recording information on electronic logs. To Conclude… While there are numerous other reasons for the failure of data integrity, starting with the points mentioned above can give you a good start in establishing a good practice. Not only will acting on these points improve the quality of products and save time, but it will also reduce the chances of receiving 483s. Ensuring data integrity is a by-product of adopting FDA-recommended best practices. For some companies, it could mean a deep-rooted cultural change. Several solutions in the market today can be adopted to resolve data integrity issues. Investing in quality software compliant with 21 CFR Part 11 and ALCOA, such as PHARMISION, is a must for organizations struggling with data integrity issues. If you want to know more about data integrity and solutions that can help you maintain it, please feel free to talk to us. You can also go through our solutions here for a better understanding.