Q379 · Department of Health inspectors repeatedly…

Q379 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)

Data integrity has been a major focus of pharmaceutical regulators worldwide in recent years. It refers to the “ALCOA+” principles, which require data throughout its lifecycle to be: attributable (who did it), legible, contemporaneous (recorded at the time the activity occurred), original and accurate. The “+” stands for complete, consistent, enduring and available. Put simply, data integrity requires all your records, whether on paper or electronic, to be genuine, reliable and untampered with. For example, an analyst must not record experimental data on scrap paper and then transcribe it into the official logbook after obtaining a “good” result; an electronic system must not allow ordinary users to amend or delete data at will without any audit trail.

📘 Regulatory basis

Major regulatory bodies such as PIC/S, WHO and FDA have all issued specific data integrity guidance. Although the Department of Health in Hong Kong has no separate guideline, its GMP/GDP inspections fully adopt the internationally recognised ALCOA+ principles as assessment criteria.

📗 Drew Tang's recommendations

We recommend that clients conduct a comprehensive data integrity risk assessment covering the entire process from data generation and processing through to reporting and archiving. For paper records, standardise record-keeping practices, prohibit pencils and correction fluid, and ensure signatures and dates are recorded correctly. For electronic systems, ensure compliance with FDA 21 CFR Part 11, with features such as audit trails, access controls and electronic signatures. Training staff in a culture of data integrity is more important than any technical measure.

📕 Risk notice

Data integrity issues, particularly the falsification or alteration of data, are the one type of non-compliance to which regulators apply “zero tolerance”. If conclusive evidence is found—for example, hidden or altered data discovered by checking waste paper, the computer recycle bin or the system audit trail—the Department of Health will almost certainly take the most severe measures, including licence revocation and criminal prosecution. This is an industry “cardinal sin”.

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang

Business Manager Tang Shangyong (Drew Tang) will review your products, operating model, licence type and preparation requirements with you one-to-one. The precise service scope is confirmed in writing; pharmaceutical duties are carried out by legally qualified personnel, and approvals are determined by the competent authorities.

Department of Health inspectors repeatedly emphasise “data integrity” (Data Integrity). What exactly does this mean?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang