Enhancing and Restoring Safety & Quality Cultures - Dave Litwiller - May 2024...
AMS360 Short Intro (1).pptx
1. Access Management System
DATASTACK
1
Access Management System
• It’s an application to Control and monitor user access permissions and
rights to various computer systems
• The system automates process flow involved in requesting access
permissions and approving of those requests
• And so, it replaces existing paper forms to request and approve access
• The application can be used by all employees to request access to any type
of application, e.g.
• enterprise applications like SCM, Trackwise
• Applications used in manufacturing, packing, QC
• Databases, Shared folders, Servers etc.
• The system will also serve as centralized repository of records of all
access permissions provided on each application across all sites.
2. AMS
360
Monitoring and Control of Access
Robust reporting capabilities for management
oversight.
Instantaneous and granular information to
Auditors.
Automated Process Workflow
Get rid of paper-based access forms and manual
approvals. Fully automated access request and approval
process flows.
Highly Configurable
Access form and approval steps are highly
configurable for each Computer Systems
Central Repository
Central repository of details of access provided to users
in all Computer Systems (Applications, Servers, Shared
folders, Databases, QC Instruments, MFG Equipment)
cGMP Compliance
Built as per CGMP* Guidelines & compliant to FDA’s 21
CFR part 11 (ESER)
DATASTACK
3. DATASTACK
Basic Workflow for Access Request
3
Access Management System
QA Manager Login
QA Manager
reviews the
request
Approve/Reject
Request
Supervisor Login
Supervisor reviews
the request
Approve/Reject
Request
IT Admin Login
IT admin reviews
the request
Completes the
access request
Mark the activity as
completed
User Login
New Request for
Access
Submit Request
Start
User
acknowledges
getting the access
End
• Multiple levels of approvals
• Can be customized for each
asset for each role
Form for each asset
can be different and
can be customized
4. DATASTACK
Important Functions
4
Access Management System
• New Access
• Remove Access
• Modify Access
• Password Reset
• Unlock Account
Types of Requests
• Access Forms
• Approval Workflow
• Access Providers
• Trainings
Configurations
• Access by user
• Access by
systemasset
• Audit Trails
Reports
• Automatic remove access requests when employee leaves organization
Access Removal