Data Integrity
Enforced by Design
GoVal enforces ALCOA+ data integrity principles at every step of the validation lifecycle — with tamper-evident audit trails, 21 CFR Part 11 e-signatures, and immutable records that satisfy FDA and MHRA requirements.
What is data integrity in pharmaceutical manufacturing?
Data integrity in pharma means ensuring all GxP data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available — the ALCOA+ standard defined by FDA and MHRA. GoVal enforces these principles across validation records through tamper-evident audit trails, structured data capture, unique user authentication, and 21 CFR Part 11 compliant electronic signatures — eliminating the manual gaps that trigger data integrity observations and warning letters.
Data Integrity Gaps Are the #1 Warning Letter Driver
Manual validation records, shared credentials, and disconnected systems create data integrity failures that regulators find in every inspection cycle.
Backdated & Altered Records
Paper records and uncontrolled spreadsheets allow backdating, unauthorized amendments, and data alteration — the most severe data integrity violation inspectors pursue.
Shared Credentials
Team logins and shared system passwords break the Attributable requirement — regulators cannot determine who performed each action in the validation record.
Missing Raw Data
Test results recorded without retaining original instrument output and metadata violate the Original and Complete requirements — a frequent observation in lab and manufacturing systems.
Incomplete Audit Trails
Systems that lack timestamped, user-attributed change logs for every modification cannot satisfy the Contemporaneous requirement of ALCOA+ or 21 CFR Part 11.
ALCOA+ Built Into Every Record, Automatically.
GoVal enforces data integrity at the system level — no configuration required. Every validation record is attributable, complete, and immutable from the moment it is created.
Unique User Authentication
Every action is attributed to a specific user through mandatory individual login — satisfying the Attributable requirement and eliminating shared credential risk.
Tamper-Evident Audit Trails
Every record change — who, what, when, and why — is captured in an immutable, timestamped log that cannot be deleted, altered, or backdated.
21 CFR Part 11 E-Signatures
Role-based electronic signatures with meaning statements and unique authentication — fully compliant with FDA 21 CFR Part 11 and EU Annex 11 signature requirements.
Structured Data Capture
Guided, field-level data entry prevents free-text workarounds and ensures test results are recorded contemporaneously with correct metadata linkage.
Role-Based Access Control
Granular permissions ensure only authorized users can view, edit, review, or approve specific records — eliminating unauthorized access and modification risk.
Compliant Long-Term Archival
Records are stored in a controlled, enduring format accessible for the full regulatory retention period — satisfying the Enduring and Available requirements of ALCOA+.
Eliminate Data Integrity Risk Across Your Organization
Systematic ALCOA+ enforcement eliminates the data integrity violations that most frequently appear in FDA warning letters to pharma and biotech companies.
Every record entry, review action, and approval is automatically linked to a specific authenticated user — no manual attribution required.
Inspectors get immediate access to complete, structured records with full change history — no pre-audit document reconstruction required.
Standardized data capture and access controls across all sites and teams eliminate the site-to-site variation that regulators target in multi-facility inspections.
Data Integrity Questions
Short answers for validation, QA, IT, and compliance teams evaluating a modern VLMS platform.
What is data integrity in pharmaceutical manufacturing?
Data integrity means ensuring all GxP data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available — the ALCOA+ standard. FDA and MHRA require pharmaceutical companies to demonstrate this across all records, including validation documentation.
What is ALCOA+ in pharma?
ALCOA+ is the regulatory framework for data integrity in GxP environments. It stands for Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring, and Available. GoVal enforces all ALCOA+ principles through structured data capture, e-signatures, and tamper-evident audit trails.
What are common data integrity failures in pharma validation?
Common failures include data backdating, shared user credentials, unauthorized record amendments, incomplete audit trails, missing raw data, and manual transcription errors. GoVal's enforced electronic workflows and immutable audit logging eliminate all of these systematically.
How does GoVal enforce data integrity?
GoVal enforces data integrity through unique user authentication, tamper-evident audit trails capturing every change, electronic signatures that cannot be shared, structured data capture forms, role-based access controls, and immutable record archival — all built into the platform by default.
What FDA guidance covers data integrity?
Key FDA guidance includes 21 CFR Part 11 (electronic records and signatures), the 2018 Data Integrity and Compliance with Drug CGMP Guidance, and the 2022 CSA final guidance. GoVal is purpose-built to satisfy requirements across all three frameworks.