Understanding FDA ALCOA Guidance for Data Integrity.

In this article, you will learn the ALCOA Guidance for Data Integrity as per FDA requirements.  Moreover, you can discover how to get a Document Management Procedure Template and Document Management Software Application to handle your GMP records activities fast and easily.

ALCOA is an acronym for;

• Attributable,
• Legible,
• Contemporaneous,
• Original,
• Accurate

It is a technique that can help ensure paper and electronic data are compliant with FDA Regulations and guidance.

ALCOA is used by regulated industries to evaluate its compliance with data integrity and is essential to ensuring Document Control Management (DCM) and Good Documentation Practices (GDPs).

ALCOA applies to paper and electronic data.  For more information about ALCOA for electronic records, press here.

ALCOA principles are essential for a complaint paper and electronic data management life cycle system, complying with GDPs, complying with GMPs, and driving data integrity initiatives.

Complete, Consistent, Enduring, and Available (CCEA) was added to ALCOA in 2010.

ALCOA-CCEA is commonly known as ALCOA-C or ALCOA+.

The information provided below defines FDA ALCOA Guidance for Data Integrity.

Attributable

All paper and electronic data must be attributable to the person generating the data including who performed an action and when. Attributable can be accomplished by recording manually by initialling and dating a paper record or by audit trail in an electronic system.

Attributable can be interpreted to mean that records should include an electronic ‘signature’ to link them to the instrument/person that made the measurement and they should also include a reference to the system being tested and the date and time it was taken. This implies electronic signatures for users signed on to the system.

Legible

All paper and electronic data must be legible and permanent. Ensuring records are legible and permanent assists with its accessibility throughout the data life-cycle including the storage of paper and electronic data.

Contemporaneous

Contemporaneous means to record the paper or electronic data at the time it is performed. Date and time stamps should flow in order of execution for the data to be credible. Data should never be backdated, or forms completed with expected results prior to execution.  The contemporaneous may include an audit trail that captures details such as additions, deletions, or alterations of information in an electronic record without obscuring the original record.  Audit trails facilitate the reconstruction of the details relating to the electronic record.

Original

Original data is the paper or electronic medium in which the data point is initially recorded including protocol, form, notebooks, spreadsheet, database, or software application. Understanding where the original data is generated to ensure content and meaning is preserved.

Accurate

For paper and electronic data to be accurate, the data should be free from errors, complete, truthful, and reflective of the observation. Editing should only be performed by using the principles of GDPs.

Moreover, you can consider the following terms incorporated recently.

The following terms are commonly known as ALCOA-CCEA, ALCOA-C, or ALCOA+.

Complete

All paper and electronic data including original test results and repeat test results must be properly recorded clearly identifying the person performing the test as well as when the test was performed.

Consistent

The data’s sequence of events should be in the expected sequence of operations and appropriately date or time stamped to demonstrate the data are contemporaneous.

Enduring

Paper and electronic data are appropriately recorded in laboratory notebooks or validated software systems including spreadsheets and databases.

Available

Paper and electronic data are required to be readily available for review, audits, or inspections for the required lifetime of the record. Paper and electronic data should be clearly indexed and/or appropriately labelled to facilitate retrieval.

For more information questions and answers about Data Integrity and Compliance With Drug CGMP Guidance for Industry press here.

CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

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You can download samples of the Document Control Management DCM procedure templates in .pdf format. 

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REFERENCES:

For more information about FDA ALCOA Guidance for Data Integrity, refer to:

httpss://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

httpss://www.fda.gov/media/118202/download

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.40

QS Regulation and Guidance • Quality System Regulation and Preamble

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/ucm230127.htm

Inspection Guide – Pages 8, 15, 21, 22 and 23

httpss://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074899.htm

Guide to Inspections of Quality Systems [Quality System Inspection Technique (QSIT)]

www.fda.gov/iceci/inspections/inspectionguides/ucm074883.htm