D2.T3.2.2 - Shaun Pitt - SharePoint the next eQMS solution · Who is QikSolve and what do we do?...
Transcript of D2.T3.2.2 - Shaun Pitt - SharePoint the next eQMS solution · Who is QikSolve and what do we do?...
Agenda
• Introduction
• What is SharePoint
• Why organisations are choosing SharePoint
• SharePoint as a platform for Quality Systems
• Q and A
Who is QikSolve and what do we do?
SharePoint Consultants & Developers
Over 10 years experience in:
Infrastructure & Information Architecture
Technical design, implementation and integration
Business Process Improvement
Hybrid, Cloud and On-Premise solution
We specialise in solutions
Document & Content management
Intranet & Team Collaboration Sites
Quality Assurance Processes
Business Management Tools
• CRM / Expense Management / HR
Who is QikSolve and what do we do?
sites content
search cloud
Documents, lists,
auditing, versioning,
office integration,
InfoPath forms
SharePoint creates
sites, internal, teams,
intranets, projects,
multi-lingual
External sharing,
Office 365, Azure,
Document, data,
information, search
refinement
What is SharePoint?
automation insight
compliance collaboration
Dashboards,
metrics, Excel 2013,
Power BI, Reporting
Workflows, email
alerts, tasks, business
process management
Sharing, personal
sites, feeds, follows,
productivity
Records
management,
auditing, security
trimming
What is SharePoint?
Why SharePoint?
collaboration productivity
remote
centralised
securityversioning
auditing
web – office - cloud
solutions
quality
rapid
ROI
• matured product, been through a number of versions (since 2003)
• deep integration with the MS Office suite and MS technology stack
• All tools available inside and outside of organisation – and to
external partners
• Allows for a mix of controlled and uncontrolled documents and
information
• Integration
Why choose SharePoint?
Why choose SharePoint?
• Universal adoption
• Resource and Support Availability
• Flexible to meet any size problem
• Speed of delivery
• Maximises ROI
• And SharePoint could already be
used in your organisation
Why SharePoint for an eQMS?
Vendor selectionCompliance & Quality process features
Document management
features
Solutions could include:
• CAPA Process
• Audit process
• Change control process
• Deviation process
• QM documents and
forms
Why SharePoint for an eQMS?
• Universal adoption
• Resource and Support Availability
• Flexibility
• Speed of development
• Data stewardship & availability
• Cloud
• Risk averse
Vendor selection
Document management
features
Why SharePoint for an eQMS?
• Electronic Signatures
• Version Control
• Workflows
• Task management
• Notifications
• Reminders
• Periodic Reviews
• Collaboration
Document management
features
Why SharePoint for an eQMS?
• Audit trail
• Document Template
• Configured to 21 CFR Part 11
• Document distribution control
• Dashboards / reporting
• Controlled document downloads
• Release / revision history
• Rule-based document naming
Compliance & Quality process features
Why SharePoint for an eQMS?
• Electronic forms
• Version control
• Dashboards/reporting
• Notifications
• Reminders
• Escalations
• Controlled tasks
Compliance & Quality process features
Why SharePoint for an eQMS?
• Business rules
• Workflows
• Audit trail
• 21 CFR Part 11
• Electronic signatures
auditability accountabilityfull traceability of the system