Cloud System Assessment

Overview

Cloud-based systems are increasingly used across pharmaceutical and life-sciences operations for quality, laboratory, manufacturing, pharmacovigilance, regulatory, training, and business processes.

While cloud platforms can offer scalability, flexibility, and operational efficiency, organizations must still ensure appropriate control over GxP data, system availability, security, supplier responsibilities, backup, recovery, change management, and validated-state maintenance.

Mediature GxP Solutions Pvt. Ltd. (MGS) supports pharmaceutical, biopharmaceutical, API, medical-device, laboratory, CRO, pharmacovigilance, and other regulated organizations with cloud-system assessment, supplier evaluation, risk assessment, validation support, data-integrity review, security-control assessment, and lifecycle governance.

Our Cloud System Assessment Services

Cloud GxP Impact Assessment

Evaluation of the system’s intended use, GxP relevance, critical data, business process, and potential impact on quality, safety, and compliance.

Cloud Supplier Assessment

Assessment of cloud vendors, software providers, hosting providers, and service partners to understand their capabilities, controls, quality practices, and responsibilities.

Shared-Responsibility Assessment

Evaluation of responsibilities between the regulated organization and cloud provider for areas such as:

• Security
• User access
• Backup
• Recovery
• Infrastructure
• Software updates
• Incident management
• Data retention
• Business continuity
• Change control

SaaS System Assessment

Compliance review of Software-as-a-Service platforms used for regulated business processes.

Cloud Validation Support

Risk-based validation support for cloud-hosted GxP systems covering requirements, configuration, testing, supplier evidence, traceability, and release.

Data Integrity Assessment

Review of how GxP data are created, transmitted, processed, stored, backed up, retrieved, archived, and protected within the cloud environment.

Security & Access Review

Assessment of authentication, authorization, role-based access, privileged accounts, user lifecycle, and other security controls relevant to GxP use.

Backup & Recovery Assessment

Review of backup arrangements, retention, restoration capability, redundancy, disaster recovery, and recovery responsibilities.

Business Continuity Review

Assessment of contingency plans and service continuity arrangements for critical cloud-based GxP operations.

Change & Release Management Review

Evaluation of how vendor updates, patches, configuration changes, upgrades, and platform releases are assessed and controlled.

Data Location & Retention Review

Assessment of data-storage arrangements, retention, archival, retrieval, and organizational responsibilities for GxP records.

Periodic Cloud Review

Support for ongoing assessment of supplier performance, incidents, changes, security, service levels, validation status, and continued system suitability.

Cloud Models We Can Support

Depending on scope, MGS can support assessment of:

• Software as a Service (SaaS)
• Platform as a Service (PaaS)
• Infrastructure as a Service (IaaS)
• Public cloud environments
• Private cloud environments
• Hybrid cloud environments
• Vendor-hosted GxP systems
• Cloud-based eQMS
• Cloud-based EDMS
• Cloud LIMS
• Cloud LMS
• Pharmacovigilance platforms
• Regulatory systems
• Other cloud-hosted GxP applications

Key Cloud Compliance Considerations

MGS may assess:

• Intended use
• GxP criticality
• Supplier qualification
• Service agreements
• Responsibility matrix
• Data ownership
• Data location
• Data integrity
• User access
• Privileged access
• Authentication
• Audit trails
• Encryption
• System availability
• Backup
• Recovery
• Disaster recovery
• Business continuity
• Incident management
• Security monitoring
• Vendor changes
• Software updates
• Data export
• Data portability
• Record retention
• Archival
• System exit strategy
• Periodic review

Our Approach

• Understand

Define the cloud service, business process, intended use, critical data, users, integrations, and regulatory relevance.

• Assess the Supplier

Review vendor capabilities, quality controls, technical environment, service model, certifications, documentation, and responsibilities.

• Assess Risk

Evaluate risks related to data, availability, security, change management, supplier dependency, and business continuity.

• Define Controls

Establish client and supplier responsibilities, validation activities, procedural controls, monitoring, and governance requirements.

• Verify

Support risk-based validation and review of configuration, security, backup, recovery, interfaces, and critical functionality.

• Maintain

Support supplier monitoring, periodic review, change assessment, incident evaluation, and continued validated-state maintenance.

Deliverables

Depending on scope, MGS can provide:

• Cloud GxP impact assessment
• Cloud supplier assessment
• Supplier questionnaire
• Responsibility matrix
• Cloud risk assessment
• Validation strategy
• Security-control assessment
• Data-integrity assessment
• Backup and recovery review
• Business-continuity assessment
• Change-management assessment
• Data-retention assessment
• Periodic-review report
• Remediation plan
• Compliance-status tracker

Why Choose MGS

GxP & Cloud Perspective

MGS evaluates cloud systems from both regulatory and technical control perspectives.

Supplier-Focused Assessment

Our approach considers the critical role of cloud vendors and clearly defines which controls remain the regulated organization’s responsibility.

Risk-Based Validation

Validation effort is focused on critical GxP functions, data, integrations, and supplier-dependent risks.

Data-Integrity Focus

MGS considers data ownership, storage, transfer, access, backup, retrieval, and retention throughout the cloud lifecycle.

Lifecycle Support

We can support cloud-system selection, implementation, validation, upgrade, periodic review, migration, and retirement.

Who We Support

MGS can provide cloud-system assessment support for:

• Pharmaceutical manufacturers
• API manufacturers
• Biopharmaceutical organizations
• Medical-device companies
• Laboratories
• CROs
• Pharmacovigilance organizations
• Quality departments
• Regulatory teams
• IT and digital teams
• Organizations adopting SaaS platforms
• Sites migrating GxP systems to cloud environments