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Saas - l4

saas - l4

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v9991 v9991
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26 views14 pages

Saas - l4

saas - l4

Uploaded by

v9991 v9991
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
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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

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