GxP & E-Signatures API
GxP compliance dashboard, electronic signatures, audit trail export, and validation template management
GxP & E-Signatures API
The GxP API provides compliance dashboard data, audit trail management, and electronic signature capabilities for FDA 21 CFR Part 11 regulated environments. All procedures require organization-level authentication (orgProcedure).
gxp.getComplianceStatus
Get the overall GxP compliance status for the organization dashboard.
Input: None
Output:
{
overallStatus: "compliant" | "partial" | "non-compliant";
categories: Array<{
name: string; // e.g., "Audit Trail", "E-Signatures", "Access Control"
status: "compliant" | "partial" | "non-compliant";
completionPercentage: number;
findings: number;
}>;
lastAuditDate: Date | null;
}
gxp.getAuditTrail
Get paginated audit trail with comprehensive filtering.
Input Schema:
{
entityType?: string; // Filter by entity type (e.g., "action", "item")
entityId?: string; // Filter by specific entity
userId?: string; // Filter by user
action?: string; // Filter by action type (create, update, delete)
startDate?: string; // ISO date range start
endDate?: string; // ISO date range end
page?: number;
limit?: number;
}
gxp.exportAuditTrail
Export filtered audit trail to CSV or PDF format.
Input Schema:
{
format: "csv" | "pdf";
filters?: {
entityType?: string;
startDate?: string;
endDate?: string;
};
}
Output: Returns a download URL for the generated export file.
eSignatures.sign
Create an electronic signature on a record with identity verification.
Input Schema:
{
entityType: string; // Type of record being signed
entityId: string; // ID of record being signed
meaning: string; // "approved" | "reviewed" | "authored" | "witnessed"
password: string; // Password re-entry for identity verification
}
Output: Returns the created signature record with timestamp and user identity.
eSignatures.verify
Verify the integrity of an electronic signature.
Input Schema:
{
signatureId: string;
}
Output:
{
valid: boolean;
signature: {
id: string;
userId: string;
userName: string;
meaning: string;
signedAt: Date;
entityType: string;
entityId: string;
};
}
eSignatures.getHistory
Get signature history for a specific record.
Input Schema:
{
entityType: string;
entityId: string;
page?: number;
limit?: number;
}
Permissions
| Procedure | Required Role |
|---|---|
gxp.getComplianceStatus | Admin or Quality role |
gxp.getAuditTrail | Admin or Quality role |
gxp.exportAuditTrail | Admin or Quality role |
eSignatures.sign | Any authenticated member |
eSignatures.verify | Any authenticated member |
eSignatures.getHistory | Any authenticated member |
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