Requirement Description
The hosting infrastructure must support scaling
Scalability resources up or down based on demand, ensuring
performance consistency.
Robust security measures including data encryption,
Security
secure access controls, and regular security audits.
Adherence to relevant industry standards and
Compliance regulations for data handling and privacy (e.g., GDPR,
HIPAA if applicable).
Mechanisms to ensure data accuracy, consistency, and
Data Integrity
protection against corruption or loss.
High availability with commitments to service level
Uptime agreements (SLAs) for system uptime, possibly 99.9%
or higher.
Capability to integrate with other enterprise systems or
Integration
third-party applications through APIs or middleware.
Regular data backups and a disaster recovery plan to
Backup & Recovery
minimize data loss and downtime.
Support for multiple users or organizations while
Multi-tenancy
ensuring data isolation and security.
Real-time monitoring of application performance and
Monitoring & Logging extensive logging for troubleshooting and auditing
purposes.
24/7 support with defined response times, regular
Support & Maintenance updates, and maintenance without significant
downtime.
Responsibilities and Accountabilities Matrix:
Activity Responsible
Infrastructure
Cloud Service Provider
Management
Security Implementation Security Engineers
Compliance Checks Compliance Officer
Data Management Data Managers
Performance Monitoring System Administrators
System Integration Integration Specialists
Backup & Disaster
IT Operations
Recovery
User Access
System Administrators
Management
Application Maintenance Software Developers
Support Services Customer Support
Accountable Consulted Informed
SaaS Provider IT Operations Executive Team
SaaS Provider Compliance Officer All Users
SaaS Provider Legal Team Executive Team
SaaS Provider Data Analysts All Departments
SaaS Provider IT Support Operations Team
SaaS Provider IT Architects Affected Departments
SaaS Provider Risk Management All Users
SaaS Provider HR for Permissions All Employees
SaaS Provider Product Managers Customer Support
SaaS Provider Product Team All Users
Requirement
1. Cloud Infrastructure
2. Application Deployment
3. Data Storage
4. User Management
5. APIs and Integrations
6. Security and
Compliance
7. Backup and Recovery
8. Monitoring and Logging
9. Scalability and
Performance
10. Documentation
RACI Matrix
Roles
P: Product Owner
A: Application Administrator
D: Developer
Q: Quality Assurance
S: Security Specialist
I: Infrastructure Engineer
U: User Support
Activities and Responsibilities
Activity
1. Cloud Infrastructure
Setup
2. Application Deployment
3. Data Storage
Configuration
4. User Management
Configuration
5. API Development
6. Security Audits
7. Backup and Recovery
Setup
8. Monitoring and Logging
Configuration
9. Scalability and
Performance Optimization
10. Documentation
Creation
11. User Support
12. Application Updates
Legend
R: Responsible
A: Accountable
C: Consulted
I: Informed
Description Priority
Scalable, secure cloud infrastructure (e.g.,
High
AWS, Azure)
Containerized deployment (e.g., Docker) for
High
easy updates
Secure, compliant data storage (e.g.,
High
encrypted, access-controlled)
Role-based access control, authentication,
High
and authorization
RESTful APIs for integrations with existing
Medium
systems
Regular security audits, GDPR, HIPAA
High
compliance
Automated backups, disaster recovery plan High
Real-time monitoring, logging, and alerting Medium
Auto-scaling, load balancing for high traffic High
Comprehensive documentation for users and
Low
administrators
and Responsibilities
P A D Q
R R
R R
R R R
Requirements for Hosting L4 RFxL in Saa
Requirement Area
Infrastructure
Data Security
Application
Configuration
Integration
Validation
Backup & Recovery
Audit Trail
Access Control
Support & Maintenance
Scalability
Licensing & Subscription
RACI Matrix for Activities Relevant to Saa
Activity
Infrastructure
Provisioning
Application
Configuration
Data Security
S I U
Implementation
Integration with
R
ERP/MES
Validation (IQ/OQ/PQ)
Backup & Recovery
R
Setup
Audit Trail Configuration
Access Control
Implementation
Ongoing Support and
R
Maintenance
R Compliance Monitoring
R
Key:
R
R R: Responsible (Performs the task)
A: Accountable (Ensures the task is completed)
C: Consulted (Provides input or feedback)
I: Informed (Kept updated on progress/results)
for Hosting L4 RFxL in SaaS Model
Details Key Considerations
Cloud-hosted environment (e.g., Must meet scalability, availability (99.9%+ uptime),
AWS, Azure, GCP) and disaster recovery requirements
Compliance with regulatory
Encryption at rest and in transit, multi-factor
standards (e.g., GDPR, HIPAA, 21
authentication (MFA), and data access controls
CFR Part 11)
Hosted application must meet
Support for GS1, EU FMD, US DSCSA, and other
traceability and serialization
regional serialization standards
standards
Seamless integration with ERP (L5) Use of APIs, middleware, or secure file exchanges for
and MES (L3) systems real-time data synchronization
SaaS vendor provides validation IQ, OQ, PQ documentation and ongoing validation
packages for compliance support
Automated backups and quick SLA for Recovery Time Objective (RTO) and Recovery
restoration processes Point Objective (RPO)
Fully compliant audit trail Complete logging of changes, with user access logs
functionality meeting 21 CFR Part 11 and Annex 11
Role-based access control (RBAC) Segregation of duties, user group hierarchies, and
for all users privilege escalation monitoring
Service-level agreements (SLAs) for incident resolution
24/7 support from SaaS provider
and scheduled maintenance notifications
Application must scale with
Support for peak loads during production cycles
transaction volume
Subscription-based model covering Flexible pricing based on the number of users and
required modules modules
or Activities Relevant to SaaS Hosting
SaaS Vendor Pharma Company IT
R A
R A
R C
C R
C R
R C
R C
R C
R A
C C
erforms the task)
Ensures the task is completed)
vides input or feedback)
updated on progress/results)
Quality Regulato
Team ry Team
C C
C C
A C
A C
A C
A C
A C
A C
C C
A R
