FDA ALCOA Guidance

In their 2003 guidance on the implementation of their 21 CFR Part 11 data integrity rule, the FDA use the acronym ALCOA, where they define good data integrity practice as creating records that are attributable to the technician carrying out the testing, are legible, are created contemporaneously, original and accurate.

ALCOA attributable legible contemporaneously recorded original accurate

The FDA 21CFR part 11 ALCOA definition of complete, consistent and accurate data

Attributable

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 water system being tested and the date and time it was taken. This implies electronic signatures for users signed on to the system. Control over electronic signature format can be site specific and is usually controlled by the IT department using Microsoft Active Directory controls. Ideally the on-line instrumentation should be configured to follow Active Directory controls to ensure correct electronic signature format according to the site-specific rules.

Legible records

The record of course is required to be legible, which implies that hand-written records are not acceptable. The FDA goes on to suggest that electronic records should be stored in a format that is open and can be read on many computing formats so that it will be accessible and readable for years to come. The FDA recommends typical formats such as PDF, XML or SGML.

Contemporaneous

The word contemporaneously implies that the electronic records should be created immediately the sample is measured, implying that manual transcription of paper records is not good practice and that collating paper records and then manually transcribing them into electronic format at a later time or date is not good practice either.

Original

Naturally there is a danger with every transcription of test results from one form to another. Even scanning multiple paper records into electronic format runs the risk of duplication or missed scans. So the FDA recommends that the electronic record should be the original record created when the test was completed. Obviously, manually transcribed records are the riskiest, attracting the biggest opportunity for human error.

Attributable records

Finally the A in ALCOA. Naturally the electronic records should be accurate. This implies that the process for capturing those electronic records should be robust, i.e. manual calculations and manual data entry where opportunities for human error exist should be avoided. Attributable is the ‘A’ in ALCOA. Electronic records generated by on-line instruments should contain information that links the data to the instrument used to make the measurement and the time and date of the measurement.

 QC Step  Instrument  Application  Regulation  A  L  C  O  A
 Raw Material  ANATEL PAT700  On-line Water for Injection (WFI), Purified Water (PW), Total Organic Carbon (TOC), Temperature and Conductivity

USP <643>

USP <645>

EP 2.2.44

 Multi-level, Individual User Name and Password for all users  Legible secure PDF export for Alarm Trail, Audit Trail, Measurement Results  Secure PDF created on day of sample analysis  Original electronic record created directly from the instrument  Your SOPs pre-programmed into instrument and automated. No manual data entry. Pass/Fail calculations
 QbD1200  Grab-sample point of use testing for Water for Injection (WFI), Purified Water (PW) Total Organic Carbon (TOC)

USP <643>

EP 2.2.44

 Multi-level, Individual User Name and Password for all users   Legible secure PDF export for Alarm Trail, Audit Trail, Measurement Results  Secure PDF created on day of sample analysis  Original electronic record created directly from the instrument  Your SOPs pre-programmed into instrument and automated. No manual data entry. Pass/Fail calculations
 LS 13 320 XR  Active Pharmaceutical Ingredient, Excipients ISO 13320  Multi-level, Individual User Name and Password for all users    Secure PDF created on day of sample analysis  Original electronic record created directly from the instrument  Your SOPs pre-programmed into instrument and automated. No manual data entry. Pass/Fail calculations
 Production  Vi-CELL BLU  Mammalian cell viability and concentration  USP <1046>  Multi-level, Individual User Name and Password for all users        Your SOPs pre-programmed into instrument and automated. No manual data entry. Pass/Fail calculations
 Vi-CELL MetaFLEX  Mammalian cell bioreactor media health    Multi-level, Individual User Name and Password for all users        Your SOPs pre-programmed into instrument and automated. No manual data entry. Pass/Fail calculations
 MET ONE 3400  Routine environmental monitoring (air particulates) in sterile manufacturing
cleanrooms
 EU GMP Annex 1, CGMP, ISO 14644-1 & -2  Multi-level, Individual User Name and Password for all users  Legible secure PDF export for Measurement Results including metadata  Secure PDF created on day of sample analysis  Original electronic record created directly from the instrument  Your SOPs pre-programmed into instrument and automated. No manual data entry. Pass/Fail calculations
 MET ONE Facility Monitoring System  Sterile manufacturing cleanroom continuous air particulate monitoring  EU GMP Annex 1, CGMP, ISO 14644-2  Multi-level, Individual User Name and Password for all users  Legible secure PDF export for Alarm Trail, Audit Trail, Measurement Results  Secure data records stored in database at time of measurement  Original electronic record created directly from the instrument  Your SOPs pre-programmed into instrument and automated. No manual data entry. Pass/Fail calculations
 Final Product Testing  HIAC 9703+  Final product sub-visible particulate counting in parenteral drug products

 USP <787>

USP <788>

 Multi-level, individual User Name and Password for all users    Secure PDF created on day of sample analysis  Original electronic record created directly from the instrument  Your SOPs pre-programmed into instrument and automated. No manual data entry. Pass/Fail calculations
 DelsaMax  Stability testing therapeutic protein formulations (protein aggregations)  USP <787>          Your SOPs pre-programmed into instrument and automated. No manual data entry. Pass/Fail calculations

Additional ALCOA Resources

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