Data Integrity

Data Integrity is a term that is broad in scope, having different meanings depending upon the context in which it is used. Within the context of FDA regulatory compliance (GMP, GLP and GCP) data integrity refers to the assurance that data maintains all of the following required elements over its entire life-cycle.

Required Elements of Data Integrity (ALCOA+)

In their April 2016 Guidance for Industry entitled “Data Integrity and Compliance with CGMP” FDA established five required elements for data integrity, whereby the first letter of each element formed the 5-letter acronym ALCOA which was intended to serve as a mental construct to aid in remembering them. FDA would go on to introduce four additional required elements and the acronym by which all nine elements have collectively come to be known is ALCOA+. The nine elements of data integrity currently required by FDA are:

• Attributable – Data must clearly indicate who is responsible for the data or who performed the recorded activity. Additionally, data must be traceable to its source such as a study, activity or a specific analytical testing run.
• Legible – Data must be recorded in a legible (readable) manner that is easily understood by others.
• Contemporaneous – Data must be recorded at the time the data is generated or the activity is performed. Manual data must be dated. Electronic data must be date and time-stamped.
• Original – Data must be retained in the format in which it was originally generated or as an accurate copy thereof.
• Accurate – Data must reflect the “actual” or “true” values and events, free from error.
• Available – Data must be accessible for review at any time throughout its entire life-cycle.
• Enduring – Data must be protected from loss or damage and remain ‘readable’ throughout its entire life-cycle.
• Complete – Data must be maintained in its complete state, i.e., nothing missing or manipulated. Electronic data requires an ‘audit trail’ to show that nothing has been changed, added or deleted.
• Consistent – Manual data must be chronological and identified with the date entered. Electronic data must have a date/time stamp that is in the expected sequence.

Data Life-Cycle

• Generation of Data – When generated to satisfy a regulatory requirement, data is immediately deemed to be a GMP/GLP/GCP record and subject to all data integrity requirements.
• Usage of Data – The usage of data (e.g., in performing calculations) is subject to all data integrity requirements.
• Storage or Archiving of Data – Data must be stored/archived in a manner which satisfies all data integrity requirements.
• Destruction of Data – The timing and effectiveness of data destruction must satisfy all data integrity requirements.

The Importance of Data Integrity

Preserving the integrity of your Company’s data throughout the entire data life-cycle is now a basic requirement of FDA regulatory compliance but it is equally important from the standpoint of running your business in an efficient manner. FDA issued its Data Integrity Guidance for Industry in response to the poor quality of data that was being observed during inspections and also being submitted in support of GMP, GLP and GCP applications such as NDAs (New Drug Applications), ANDAs (Abbreviated New Drug Applications), INDs (Investigational New Drug Applications) and 510(k) Medical Device Applications. The requirements for Data Integrity are here to stay. Noncomplying organizations can expect to encounter FDA enforcement action and the rejection of regulatory submissions.

CPT Can Assure the Integrity of Your Test Results and Supporting Data.

You can no longer afford to entrust your testing to a laboratory that is not fully compliant with FDA data integrity requirements. Whether it be Analytical Chemistry, Microbiological, Clinical, Photobiological or In-Vitro Toxicological testing, FDA demands compliance with ALCOA+ data integrity requirements. A dependable testing laboratory recognizes that obtaining accurate test results is only one-half of their responsibility; The second-half is maintaining a highly compliant testing environment in which data integrity is assured throughout the data life-cycle. Give us a call…we won’t let you down.