Pharmaceutical organizations, as with other industrial sectors, have taken advantage of computerization and this area is expanding as part of digital transformation initiatives (not least the automation of areas of laboratory testing or with drug discovery). This leads to challenges of how to capture, analyze, and archive data and metadata (‘data about data’, such as the time that a datum was recorded).
Although there many safeguards in replace (most of which fall under the auspices of Good Manufacturing Practice), things can still go wrong when pharmaceuticals are manufactured (see Digital Journal’s coverage of the infamous New England Compounding Center as an example).
Most recently regulators have turned their focus and attention towards Records and Data Integrity (RDI) as that is fundamental to the evidence created across all aspects of GMP. The regulators have positioned a number of key statements to clarify their expectations. The U.S. Food and Drug Administration (FDA), for instance has increasingly observed Good Manufacturing Practice violations involving data integrity during inspections. The Agency regards this as troubling since ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs. Moreover, these data integrity-related violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees.
The U.K. medicines agency, the Medicines and Healthcare products Regulatory Agency
(MHRA) uses a mnemonic to help guide practitioners with good data integrity practices, This is ALCOA, which represents:
A – Attributable: Records and data linked to the individual or system performing the action.
L – Legible: Records and data readable and traceable across the lifecycle.
C – Contemporaneous: Records and data reported at the time it has occurred.
O – Original: Records and data are the primary source (or true copy).
A – Accurate: Records and data are correct and free from errors.
To this some add ‘ALCOA-plus’, adding in:
Complete: Records and data are complete (including any repeat runs, analysis),
Consistent: Records and data enable reconstruction of events, results and sequences,
Enduring: Records and data are recorded in permanent form and preserved,
Available: Records and data are available for review, audit and inspections.
Pharmaceutical organizations can avoid regulatory citations, according to industry watcher Orlando Lopez. Writing in Pharmaceutical Technology, Lopez says that the most common error is not considering how records will be captured and tracked, including considerations as to how any changes are captured in an audit trail, as part of the design process. To overcome this, Lopez states, it is necessary to ensure integrity of electronic records as part of a system validation and implementation will ensure a positive compliance report.
Cultural change is important too, in parallel with the technological strategy. Records and data integrity governance is the sum total of company policy, procedures, people and the an organization’s quality management system.
