The U.S. Food and Drug Administration (FDA) emphasize the importance of data integrity in pharmaceutical manufacturing, particularly under its Current Good Manufacturing Practices (CGMP) rules. However, issues like fake lab results and sloppy record-keeping persist, posing risks to patients and losing confidence in the system. Independent oversight is crucial to ensure the quality of drugs we rely on, as it helps prevent slip-ups and maintains trust in the system.
What are the Data Integrity, and Why Should We Consider?
Data integrity is crucial for ensuring complete, reliable, and accurate information from start to finish. The FDA uses the acronym ALCOA—
Attributable, Legible, Contemporaneous, Original, Accurate, to represent this goal. If any of these elements fail, it’s impossible to prove a drug’s safety or functionality. For instance, a lab tech forgetting to log a bad test result or a batch record being messed with using a shared password can lead to a contaminated drug or a massive recall. The FDA issued a guide in 2016 to address this issue, but companies still need to improve.
Where Things Keep Going Wrong?
- Deficient Audit Trails: Electronic records, like chromatogram files, require information about who and when to accurately record events. If such details are missing, it is impossible to analyse the trial
- Shared Passwords: Shared accounts can hinder accountability, as CGMP suggests that every move should be tied back to a person, but shared accounts can complicate this process.
- Intentionally Deletion of Data: Removing an undesirable result without a solid reason can be a quick way to conceal issues.
- Paper Records: FT-IR spectrometers produce paper reports that may not provide the full details, indicating system cracks that can compromise quality, necessitating double-checking and addressing these details for future reference.
Why Independent Oversight Makes a Difference?
Here’s why Zenovel think having an outside set of eyes is a game-changer:
- No inside Pressure: A third-party auditor is crucial in ensuring a company’s work is accurate and fair, as it helps to identify potential errors to meet deadlines or save money, as per the FDA’s recommendation to involve outsiders when data is suspicious.
- Keeping People Honest: An independent reviewer can identify issues early in audit trails, ensuring accountability by examining shared logins and sloppy records.
- Checking the Tech: Labs use complex systems like LIMS or electronic batch logs, requiring unbiased oversight to prevent data manipulation and potential glitches, as without it, errors can occur.
- Building Trust: The FDA emphasizes the importance of follow-through in identifying data issues, stating that regular audits and clear reporting methods allow individuals to voice concerns without fear of legal consequences, even a minor tip about skewed data.
What Companies Should Do
- Strict internal audit, no shared passwords, robust workflow
- Perform third party audit to identify the potential issues within company
- Give training to the staff and identify data related red spots
- Keep the raw electronic files, much less paper documents which can easily trace
Overall, Data integrity is crucial for pharmaceutical products to meet safety and efficacy standards, and independent oversight is essential to prevent errors and falsification. The FDA mandates transparency and accountability, which underpin drug manufacturing processes and public confidence in therapeutic outcomes. As technological complexity increases and global supply chains expand, adherence to robust data integrity protocols is essential for compliance and patient protection.
Zenovel helps in maintenance and assurance of the accuracy and consistency of data over its entire life cycle. We address the issue related to the data by the physical and logical integrity.
In physical integrity our team resolves data storage and retrieval issues, ensuring data safety from computer malfunctions and disasters. We also suggests installing backup and recovery solutions, maintaining physical integrity through backup devices, electricity supply, RAID Arrays, archives, and encrypted hash functions. We ensure that problem detecting techniques must be utilized to ensure data safety. In case of logical integrity, our team ensures integrity and trustworthiness of data within a system, ensuring its rigidity, precision, and accuracy. It involves maintaining the linkages and restrictions that define the data’s structure and accurately representing the actual entities it is intended to record. This is crucial for accurate interpretation and use within databases and information systems.
