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Pharmaceutical Data Integrity ALCOA Checklist

Interactive GMP checklist for pharmaceutical data integrity, ALCOA principles, ALCOA+ expectations, documentation, audit trails, electronic records and corrective actions.

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Pharmaceutical Data Integrity ALCOA Checklist

This pharmaceutical data integrity checklist is designed to help QA, QC, GMP, regulatory and compliance professionals assess documentation and data controls against the fundamental principles of ALCOA and related ALCOA+ expectations.

The checklist can be used during internal audits, self-inspections, routine GMP reviews, data integrity assessments, laboratory inspections and preparation for regulatory inspections.

Quick Answer: ALCOA refers to five fundamental expectations for trustworthy pharmaceutical data: Attributable, Legible, Contemporaneous, Original and Accurate. ALCOA+ extends these expectations with additional principles including complete, consistent, enduring and available data.

7 ALCOA+ Sections

35 Checkpoint Items

25 Required Responses

4 Key Standards

Checklist Completion 0%

0 of 25 required responses completed Not Started

📋 Inspection Information

Complete the inspection details before evaluating the checklist.

Site / Facility Name *

Inspection Date *

Inspector Name *

Department * Select department Quality Assurance Quality Control Production R&D Regulatory Affairs Engineering Warehouse Other

Supervisor / QA Contact

Batch / Lot / Reference No.

1. Attributable

5 Items ▼

1.1

Are all GMP records attributable to the person who performed the activity? *

Verify that records identify the individual responsible for performing, reviewing or approving the activity.

✓ Yes

✕ No

1.2

Are individual user accounts used for electronic GMP systems? *

Verify unique user identification and appropriate access controls. Shared accounts should not obscure individual actions.

✓ Yes

✕ No

N/A

1.3

Are electronic signatures linked to the individual user? *

✓ Yes

✕ No

N/A

1.4

Are audit trail entries attributable to individual users? *

✓ Yes

✕ No

N/A

1.5

Are responsibilities for creating, reviewing and approving records clearly defined? *

✓ Yes

✕ No

2. Legible

5 Items ▼

2.1

Are GMP records clear, readable and permanent throughout the retention period? *

✓ Yes

✕ No

2.2

Are corrections made without obscuring the original information? *

Check correction practices for paper records, including reason/date/initial requirements where applicable.

✓ Yes

✕ No

N/A

2.3

Are scanned or digitized records sufficiently clear for review? *

✓ Yes

✕ No

N/A

2.4

Are entries protected from unauthorized alteration or deterioration? *

✓ Yes

✕ No

2.5

Can records be readily read and understood during QA review? *

✓ Yes

✕ No

3. Contemporaneous

5 Items ▼

3.1

Are activities recorded at the time they are performed? *

Verify that personnel do not rely on unofficial notes, memory or retrospective recording.

✓ Yes

✕ No

3.2

Are date and time entries recorded accurately? *

✓ Yes

✕ No

3.3

Are laboratory results entered immediately after testing? *

Particularly important for HPLC, GC, dissolution, microbiology and other computerized laboratory systems.

✓ Yes

✕ No

N/A

3.4

Are retrospective entries appropriately identified and justified? *

✓ Yes

✕ No

N/A

3.5

Are system clocks synchronized and appropriately controlled? *

✓ Yes

✕ No

N/A

4. Original

5 Items ▼

4.1

Are original records or true copies maintained? *

✓ Yes

✕ No

4.2

Are raw data, metadata and associated records retained? *

✓ Yes

✕ No

N/A

4.3

Are original laboratory electronic data retained? *

Verify that chromatographic, spectroscopic and other computerized analytical data are not replaced by reports alone.

✓ Yes

✕ No

N/A

4.4

Are true copies verified for completeness and accuracy? *

✓ Yes

✕ No

N/A

4.5

Are unofficial worksheets or temporary records controlled? *

✓ Yes

✕ No

5. Accurate

5 Items ▼

5.1

Are calculations verified and mathematically correct? *

✓ Yes

✕ No

5.2

Are instruments calibrated and within their required status? *

✓ Yes

✕ No

N/A

5.3

Are transcription errors checked and controlled? *

✓ Yes

✕ No

5.4

Are analytical results supported by complete raw data? *

✓ Yes

✕ No

N/A

5.5

Are abnormal, invalid or unexpected results investigated appropriately? *

✓ Yes

✕ No

6. Complete & Consistent

5 Items ▼

6.1

Are all data generated during an activity retained? *

✓ Yes

✕ No

6.2

Are audit trails enabled where required and appropriately reviewed? *

✓ Yes

✕ No

N/A

6.3

Are deleted, invalidated or reprocessed results retained and explained? *

✓ Yes

✕ No

N/A

6.4

Are data sequences complete and consistent with the performed activity? *

✓ Yes

✕ No

6.5

Are backup and restoration controls sufficient to preserve complete data? *

✓ Yes

✕ No

N/A

7. Enduring & Available

5 Items ▼

7.1

Are records protected throughout the required retention period? *

✓ Yes

✕ No

7.2

Can authorized personnel retrieve data when required? *

✓ Yes

✕ No

N/A

7.3

Are archived electronic records protected from unauthorized modification? *

✓ Yes

✕ No

N/A

7.4

Are data available for QA review and regulatory inspection? *

✓ Yes

✕ No

7.5

Are data integrity deficiencies documented and assigned corrective actions? *

✓ Yes

✕ No

Corrective Action / Observation

0 Completed

0 Yes

0 No

0 N/A

Inspection Result

0%

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Pharmaceutical Data Integrity Audit Ready?

Use this interactive ALCOA checklist for internal GMP reviews, QA assessments, laboratory data integrity checks and audit preparation.

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Pharmaceutical Quality Assurance • GMP • QA/QC • Data Integrity

This checklist is an educational inspection aid. Always compare checklist requirements with your organization's approved SOPs, quality system and applicable regulatory requirements.