Q319 · What does “Data Integrity” mean in a QMS?…

Q319 · Category G: Quality management and compliance systems (Q301–Q350)

Data integrity means the completeness, consistency and accuracy of data. In pharmaceutical regulation, it is commonly summarised by the “ALCOA+” principles: data should be attributable, legible, contemporaneous, original and accurate. The “+” stands for complete, consistent, enduring and available. Paper records and electronic data must both comply with these principles. Data integrity is crucial because all decisions about the quality, safety and efficacy of medicines are based on this data. If the data is unreliable, the entire quality system and all evidence of compliance lose their foundation.

📘 Regulatory basis

Although the term “data integrity” does not appear expressly in every piece of legislation, its principles are embedded throughout GMP and GDP. For example, PIC/S and the World Health Organization (WHO) have both issued dedicated data integrity guidelines, which have become inspection standards for regulators worldwide, including the Hong Kong Department of Health.

📗 Drew Tang's recommendations

We recommend that clients safeguard data integrity through both technology and culture. Technically, use validated electronic systems with audit trail functionality, restrict data amendment permissions, and ensure system security and data backups. Culturally, emphasise to all staff the importance of honest record-keeping, and strictly prohibit data falsification or retrospective “completion” of records. Include data integrity as a dedicated checkpoint in internal audits.

📕 Risk notice

Data integrity is one of the key areas of focus in pharmaceutical regulatory inspections worldwide. Any form of data falsification, deletion or improper amendment, once discovered, will be regarded as serious deception. This will not only result in a failed inspection and severe regulatory penalties, but may also destroy the company’s reputation. Regulators may consequently question the authenticity of all data you have submitted in the past.

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.

What does “Data Integrity” mean in a QMS? Why is it so important?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang