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GxP Compliance & Validation

Compliance &
Validation Support

Biocore's regulatory intelligence infrastructure is built for the highest compliance standards. Comprehensive documentation and validation support for pharma teams deploying in GxP-regulated environments.

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SOC 2 Type II
21 CFR Part 11
GxP Validated
AES-256
GDPR
SOC 2 Type II
Security controls audit
21 CFR Part 11
Electronic records & signatures
GxP Validation
IQ / OQ / PQ documentation
FDA Inspection
Documentation & support
AES-256
Encryption at rest & in transit
GDPR
EU data protection compliance
Enterprise

Request Compliance Documentation

SOC 2 reports, GxP validation packages, and VQQ — available to enterprise customers.

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Security

Security Standards

Security

SOC 2 Type II Report

Biocore maintains security controls aligned with SOC 2 Type II standards. Security documentation is available for enterprise customers to support vendor qualification and security assessments.

Available Documentation

SOC 2 Type II audit report (under NDA for enterprise customers)
Security control documentation
Penetration testing reports (summary available)
Security assessment questionnaires

Request Process: Contact [email protected] for SOC 2 reports. Provided within 5–7 business days. A non-disclosure agreement (NDA) may be required.

Encryption

Data Encryption

All data is encrypted at rest and in transit using AES-256 and TLS 1.2+. Encryption controls are applied uniformly across stored regulatory data, backups, and API communications.

Encryption Controls

AES-256 encryption for all data at rest
TLS 1.2+ for all data in transit
Encrypted backups with managed key rotation
API communications secured end-to-end
Data Privacy

GDPR Compliance

Biocore's platform and data handling practices are designed with GDPR requirements in mind. Data processing agreements (DPAs) are available for enterprise customers operating under EU data protection obligations.

Data Protection Measures

Data Processing Agreements (DPAs) available on request
EU data residency option for GDPR-regulated deployments
Data subject request support and documented procedures
Privacy-by-design principles applied across platform
Sub-processor disclosure available to enterprise customers

DPA Requests: Contact [email protected] to request a Data Processing Agreement.

GxP & Regulatory

Regulatory Compliance Frameworks

FDA

21 CFR Part 11 Feature Matrix

Biocore Services are designed to support 21 CFR Part 11 compliance requirements for electronic records and electronic signatures.

Available Features

Audit Trails — comprehensive logging of all system activities
Access Controls — user authentication and role-based access
Electronic Signatures — support for Part 11 Subpart C requirements
Data Integrity Controls — mechanisms to prevent unauthorized modification
Data Provenance Tracking — complete lineage and history of changes
Record Retention — configurable data retention policies

Detailed Specifications: Contact [email protected] for detailed feature documentation.

Important: Biocore provides the tools and infrastructure to support compliance, but Customer must validate and operate the system in accordance with applicable regulations. See Terms of Service Section 7.

GxP

System Validation Documentation Package

Biocore provides comprehensive validation documentation packages to support your GxP validation process — facilitating IQ, OQ, and PQ protocols.

Documentation Package Includes

IQ Protocols — Installation Qualification protocols and test scripts
OQ Protocols — Operational Qualification protocols and test scripts
PQ Protocols — Performance Qualification protocols and test scripts
Validation Summary Report — template for validation summary reporting
System Documentation — architecture, data flow, security controls
Change Control Procedures — system update and validation impact procedures

Request Process: Contact [email protected] for validation documentation packages. Typically provided within 7–10 business days.

Important: Customer is solely responsible for system validation. Biocore provides documentation to facilitate validation but does not provide regulatory consulting or validation services. See Terms of Service Section 7.

Audit

Audit Trail Specifications

Comprehensive audit logging and monitoring capabilities to support compliance tracking and regulatory inspection requirements.

Audit Trail Capabilities

Comprehensive Logging — all system activities and data changes
User Identification — all actions attributed to specific users
Timestamp Precision — compliant with GxP requirements
Action Tracking — modifications, deletions, and access attempts
Reason for Change — change reason tracking where applicable
7-Year Retention — audit logs retained for GxP compliance
Tamper-Evident — audit logs protected against unauthorized modification
Export Capabilities — logs exportable for regulatory inspection

Detailed Specifications: Contact [email protected] for logging format, retention policies, and export capabilities documentation.

Signatures

Electronic Signature Specifications

Support for electronic signature requirements designed to meet 21 CFR Part 11 Subpart C compliance.

Electronic Signature Capabilities

Signature Capture — electronic signature capture mechanism
Signature Information — printed name, date/time, and meaning captured
Record Linking — signatures linked to records and cannot be disassociated
Tamper-Evident — signatures protected against unauthorized modification
Authentication — user authentication required before signature capture

Detailed Specifications: Contact [email protected] for implementation details and Part 11 Subpart C compliance documentation.

Important: Customer is responsible for proper use of electronic signatures and adherence to applicable GxP and FDA regulations. See Terms of Service Section 7.

Operations

Operations & Infrastructure

Resilience

Data Backup & Disaster Recovery

Comprehensive data backup and disaster recovery procedures to ensure data availability and business continuity.

Backup & Recovery Capabilities

Backup Frequency — regular automated backups with configurable frequency
Data Retention — policies aligned with compliance requirements
Disaster Recovery — comprehensive disaster recovery procedures
RTO — Recovery Time Objective specified in SLA
RPO — Recovery Point Objective specified in SLA
Business Continuity — continuity planning and documented procedures

Detailed Specifications: Contact [email protected] for backup frequency, retention policies, RTO/RPO, and continuity procedures.

SLA: Specific backup and disaster recovery commitments are detailed in the Service Level Agreement provided with your Order Form. See Terms of Service Section 1.

Qualification

Vendor Qualification Questionnaire (VQQ)

Biocore provides Vendor Qualification Questionnaires and equivalent documentation to support pharmaceutical vendor qualification processes.

Available Documentation

Standard Vendor Qualification Questionnaire (VQQ)
Security assessment questionnaires
Compliance documentation summaries
System capability documentation

Request Process: Contact [email protected] to request VQQ documentation. Typically provided within 5–7 business days.

FDA

FDA Inspection Support

Biocore provides reasonable cooperation and support during FDA inspections of Customer facilities, including system documentation, validation materials, and technical support.

Inspection Support Includes

System documentation and validation materials
Responses to FDA inquiries about system capabilities
Technical support during inspections (with advance notice)
Audit logs and system documentation for inspection purposes

Inspection Support Process: Contact [email protected] with advance notice. See Terms of Service Section 12 for detailed provisions.

Change Management

Change Control Procedures

Controlled change management procedures to ensure system updates are managed in a manner that supports customer validation requirements.

Change Control Process

Advance Notification — minimum 30 days notice of system updates (managed hosting)
Change Control Documentation — impact assessments provided for each change
Rollback Procedures — available if updates impact validated processes
Validation Impact Assessment — provided for changes affecting validated state
Documentation Support — guidance to support GxP validation requirements

Detailed Procedures: Contact [email protected] for notification timelines, validation impact assessment process, and rollback procedures.

Self-Hosted Deployments: Customer has complete control over system updates and assumes full responsibility for validation and compliance. See Terms of Service Section 8.

Resources

Additional Resources

Terms of ServicePrivacy PolicyDocumentationSchedule Demo
Enterprise Ready

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Our team will provide the compliance documentation packages your organization needs, on your timeline.

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