ALCOA+ is a culture, not a checklist
ALCOA+ — Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available — has become the universal framework for data integrity in regulated life sciences. Yet most organisations treat it as a compliance checklist rather than an operational philosophy. The result is a gap between what SOPs say and what bench scientists actually do.
Data integrity failures are now the leading cause of regulatory warning letters, GLP non-compliance findings, and FDA Form 483 observations globally. In India, the NGCMA has intensified its focus on data integrity during GLP inspections, and CDSCO is incorporating data integrity assessments into manufacturing facility audits.
Common failure modes in Indian laboratories
The most frequent data integrity failures we encounter in Indian life-science organisations are not deliberate fraud — they are systemic design failures. Hybrid (paper + electronic) data systems with no clear data lifecycle definition. Audit trails that are enabled but never reviewed. Electronic signatures that do not meet 21 CFR Part 11 or Annex 11 equivalents. Training records that confirm awareness of ALCOA+ but not competence in applying it.
Designing integrity into systems
Effective data integrity is designed into workflows, not audited into compliance. This means: defining your critical data and metadata for every study type, mapping the complete data lifecycle from creation to archival, implementing technical controls (access restrictions, audit trails, backup validation) before relying on procedural controls, and establishing a data governance structure with clear accountability.
The role of culture and leadership
Technical controls alone are insufficient. Data integrity requires a culture where errors are reported without fear, where corrections follow documented procedures, and where leadership visibly prioritises accuracy over speed. Test Facility Management and Study Directors set this tone — and inspectors assess it through personnel interviews, not just document reviews.
Building an ALCOA+ remediation programme
For organisations that have received data integrity observations — or want to prevent them — LaborWissen offers a structured remediation programme. We begin with a data integrity risk assessment across your systems, processes, and personnel. From there, we design and implement targeted interventions: system configuration improvements, SOP revisions, role-specific training with competency assessment, and a monitoring programme that catches drift before inspectors do.