ALCOA was born in the 1990s as FDA’s five principles of data integrity. The industry later added four more (Complete, Consistent, Enduring, Available), represented as “ALCOA+”. EMA’s guidance on computerized systems then added a tenth: Traceable, manifesting as “ALCOA++”.
ALCOA++ is not legally binding, but it is the bar data records must clear to count as trustworthy evidence. For validation professionals, these standards are never out of sight as failing them has resulted in countless observations and warning letters.
VLMcare is a modern digital validation platform that focuses on data over documents. Its object-based approach is ideal to upholding data integrity standards. Here’s how:
- Attributable: every data point must be traceable to the person who created or changed it. Every review, approval, and execution in VLMcare routes through an authenticated, Part 11-compliant e-signature, with a timestamped record of who did what. Where segregation-of-duties requires it, verified/unverified execution paths allow an independent reviewer to sign off separately from the person who ran the test without a separate system or manual handoff.
- Legible: data must be clear and understandable. Within VLMcare, requirements, risk items, and test cases exist as structured objects rather than paragraphs inside a document, and each object has a permanent page showing its full history in one view. Test execution is guided step by step, with method, expected result, and actual result captured in a consistent structure.
- Contemporaneous: data must be recorded at the time of the event, not reconstructed afterward. VLMcare explicitly enforces evidence capture at the moment of execution: mandatory fields block progress until evidence is attached, and every piece of evidence is automatically timestamped in both the file name and the audit trail, closing the door on backdating or after-the-fact reconstruction.
- Original: source data should exist once and be preserved, not duplicated and drifted. Because requirements, risk items, and test cases live as discrete objects rather than copy-pasted content across documents, there’s one system of record without content drift. Pre-approved external documents — vendor IQ reports, for instance — can be uploaded directly as originals rather than re-keyed into a new format.
- Accurate: data must be free of undocumented errors or amendments. Risk priority calculates automatically from standard FMEA inputs (instead of a subjective judgment call), and the trace matrix is auto-generated from programmatic object links versus manually transcribing rows between separate documents.
- Complete: every test, repeat, and reanalysis must be documented — not just the clean run. VLMcare’s Validation Summary Report pulls together every linked requirement, risk item, test result, defect, and remediation action automatically, with zero manual compilation. Because a defect record is generated directly from a failed test and the retest ties back to the original failure, the full sequence — including what didn’t pass the first time — stays in the record.
- Consistent: the same process must be applied the same way every time. A standardized, repeatable FMEA scoring method means two different teams validating two different systems apply risk-based rigor identically. Pre-configured, GAMP-aligned deliverable sets auto-populate based on system type and category, so the required deliverables don’t vary by who’s setting up the project.
- Enduring: the record must survive, durably, in a validated system. VLMcare holds every object as a permanent, individual record. Finalized documents generate automatically into PDFs and land in a managed repository rather than living as an editable file on someone’s desktop.
- Available: data must be accessible for review, audit, or inspection throughout its life. Real-time dashboards in VLMcare surface deliverable status as it happens, complete audit trails export to PDF or Excel on demand, and testing and review can happen from any device. VLMcare removes the common bottleneck of evidence getting trapped or forgotten on one machine or in one inbox.
- Traceable: data must be traceable through the entire process and lifecycle, including every change. This is the foundation of VLMcare’s value to validation teams: because requirements, risk items, and test cases are modeled as connected objects versus static document content, the trace matrix is inherently a live view of relationships that already exist, including the many-to-many links (shared components, cross-system requirements) that are very difficult to trace by hand.
As every validation professional knows, data integrity is not an empty, performative checklist. It is the backbone of quality. And the most important ingredient in passing inspections and audits with flying colors.
VLMcare’s inherent architecture supports and enforces ALCOA++. Every facet of the product ensures data integrity is foundational to every validation program.
