ALCOA & ALCOA Plus - Importance of Data integrity in Pharmaceutical industry | Pharma Udyog | Interview

Data integrity has recently been in the agency spotlight. In part because of the draft data integrity guidance issued April 2016, but primarily due to an increased number of inspection findings involving the reliability and trustworthiness of data. Expectations for ensuring data integrity are evolving and increasing. The rise in 483 observation citations and warning letter rates issued for relating to data integrity is direct evidence of this trend.

We rely on this industry standard initialism known as ALCOA, which has been expanded on to ALCOA+ (currently used by the FDA, WHO, PIC/S and GAMP – Data Integrity), this neatly requires all data to have the following qualities:

• Attributable — Who acquired the data or performed an action and when?
• Legible — Can you read the data and any entries?
• Contemporaneous — Documented at the time of the activity.
• Original — A written printout or observation or a certified copy thereof.
• Accurate — No errors or editing without documented amendments.
• Complete — All data including any repeat or reanalysis performed on the sample. 
  
• Consistent — All elements of the analysis such as the sequence of events follow on and are date or time stamped in the expected sequence.
• Enduring — Not recorded on the back of envelopes, cigarette packets, sticky notes, or the sleeves of a coat but in notebooks or electronic media in the data systems of instruments.
• Available — Can be accessed for review and audit or inspection over the lifetime of the record.

Data Integrity and ALCOA

Data Integrity is increasingly becoming a critical GMP issue the in the Pharmaceutical and Medical Device Industry, originally the ALCOA acronym was used as a simple and practical guide by Stan Woolen of US FDA as to the US FDA expectations regarding evidence of both paper-based, electronic, and hybrid quality systems or records. As such, it has been helpful in developing strategies to prospectively generate strong evidence in both research and manufacturing endeavors. It is now a GMP imperative that all staff are trained in ALCOA and Data Integrity to ensure a company culture that values data integrity. The ALCOA helps us to define what we mean when we say data should have integrity or our data, records and actions.