Data Integrity & CSV
Data Integrity Assessments
Comprehensive data integrity assessments aligned to ALCOA+ principles, MHRA Data Integrity Guidance and FDA expectations, covering laboratory systems, manufacturing systems and hybrid paper-to-electronic environments.
Executive Overview
Data integrity, the completeness, consistency and accuracy of data throughout its lifecycle, is the single most cited area in FDA warning letters and EMA/MHRA inspection reports over the past decade. Regulatory authorities have made clear that data integrity failures represent a fundamental breakdown in the reliability of pharmaceutical quality systems, regardless of whether they result in product quality issues.
ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) provides the framework for evaluating data integrity across all GxP-regulated data generating activities. Meeting this standard in practice requires more than documented procedures, it requires system configurations that prevent manipulation, user access controls that enforce attributability and organisational cultures that do not generate pressure for data falsification.
Sthira Assure data integrity assessments systematically evaluate each element of the ALCOA+ framework across your computerised and hybrid data systems. We assess audit trail configuration, user access management, raw data controls, system administrator practices and the organisational context that shapes data integrity behaviours. Our findings identify both technical vulnerabilities and cultural risk factors that remediation programmes must address.
ALCOA+ Framework
- Attributable
- Legible
- Contemporaneous
- Original
- Accurate
- Complete
- Consistent
- Enduring
- Available
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Get in TouchCommon Compliance Risks
Audit Trail Deficiencies
The audit trail is the primary mechanism by which regulators verify data integrity. Organisations frequently configure systems with audit trails disabled, set to overwrite, or not capturing all relevant data operations. Inspectors specifically test audit trail functionality, and organisations that cannot demonstrate contemporaneous, complete and tamper-evident records face significant findings regardless of product quality.
Shared Login Credentials
Data attributability, the ability to identify who created or modified a data record, is fundamental to ALCOA+. Shared user accounts, generic login credentials and inadequate user access management make attributability impossible. This is one of the most frequently cited data integrity findings across FDA warning letters and MHRA inspection reports.
Undocumented Testing Practices
Practices such as unofficial testing (testing outside the analytical sequence), sample bracketing, result cherry-picking and unofficial standard preparation are among the most serious data integrity violations. These practices are rarely documented and can only be identified through rigorous assessment of analytical systems, personnel interviews and comparison of system audit trails with batch records.
Gaps at Paper-to-Electronic Boundaries
Many analytical laboratories operate hybrid systems where instrument-generated data is manually transcribed into paper records or LIMS entries. Each transcription point creates a data integrity vulnerability. Inspectors assess whether transcription processes are controlled, verified and free from opportunities for result selection or manipulation.
Scope of Assessments
Typical Deliverables
Frequently Asked Questions
What is ALCOA+ and how does it apply to pharmaceutical data?
ALCOA+ is the acronym for the key attributes that pharmaceutical data must have throughout its lifecycle: Attributable (traceable to the person or system that created it), Legible (readable and permanent), Contemporaneous (recorded at the time of the activity), Original (first capture of data, not transcribed), Accurate (correct, truthful, complete) — extended by Complete, Consistent, Enduring and Available. Regulatory authorities assess data against each ALCOA+ element. A single failure — data that cannot be attributed to an individual, or an audit trail that has been deleted — constitutes a data integrity finding.
What constitutes a data integrity failure in regulatory terms?
Regulatory authorities define data integrity failures broadly: any practice that compromises the completeness, accuracy or authenticity of a regulatory record. This includes shared user credentials (preventing attributability), audit trails configured to be overwritten or disabled, deletion of original data files, unofficial or pre-testing outside the official analytical sequence, result selection, manual alteration of instrument printouts and retroactive corrections without justification and counter-signature. Even practices that do not affect the accuracy of the final result are cited as violations if they compromise the traceability of the original record.
How do you assess data integrity in hybrid paper-electronic systems?
Hybrid systems — where instrument-generated electronic data is manually transcribed into paper records — create specific data integrity vulnerabilities at each transcription point. Our assessment examines whether raw electronic data is retained in its original form, whether transcription processes are controlled and verified, whether there is opportunity to selectively transcribe results, and whether the paper record accurately reflects the electronic source data. We also assess whether the system has been identified as hybrid and whether appropriate controls have been documented and verified.
What should a data integrity remediation programme include?
An effective data integrity remediation programme addresses both technical and cultural risk factors. Technical elements include audit trail configuration remediation, access control remediation, system administrator privilege restrictions and hybrid system controls. Cultural elements include root cause investigation of how the practices developed, management awareness and accountability, SOP revision, training and a monitoring programme to verify sustained improvement. Regulatory authorities expect remediation programmes to address root causes, not just implement technical controls, and to include evidence of effectiveness verification.
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