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Process Analysis & AutomationOur research delivers the highest quality process analytical technology and lab automation solutions
ISO 9001 : 2000 certified
For more information contact Mike Collins: +44 (0)1252 373000 • [email protected] • www.paa.co.uk
• Laboratory Automation Specialists (Overlord - graphical lab automation interface)
• Process Acoustic Monitoring Systems (GranuMetXP - acoustic emission systems)
• 21 CFR Part 11 Compliant Software Solutions (Solution11XL & Solution11 developers toolkit)
For more information contact Mike Collins: +44 (0)1252 373000 • [email protected] • www.paa.co.uk
What is Solution11XL?
• Solution11XL ‘wraps’ existing Excel software
• Enables full 21CFR part 11 compliance
• No modification to native Excel file format
• Solution11XL ensures complete data security
• Full lifecycle documentation available
• GAMP4 category 3 development
• Deployed on network or workstation
For more information contact Mike Collins: +44 (0)1252 373000 • [email protected] • www.paa.co.uk
Solution11XL features
• Security and access control
• Electronic signature
• Secure audit trail
• User management
• Strong encryption
• Handles legacy Excel files
• Lifecycle documentation
For more information contact Mike Collins: +44 (0)1252 373000 • [email protected] • www.paa.co.uk
Excel spreadsheet
For more information contact Mike Collins: +44 (0)1252 373000 • [email protected] • www.paa.co.uk
Solution11XL Excel audit trail
For more information contact Mike Collins: +44 (0)1252 373000 • [email protected] • www.paa.co.uk
Solution11XL e-signatures
For more information contact Mike Collins: +44 (0)1252 373000 • [email protected] • www.paa.co.uk
Solution11XL manager
For more information contact Mike Collins: +44 (0)1252 373000 • [email protected] • www.paa.co.uk
Solution11XL user manager
System Administrator access only
For more information contact Mike Collins: +44 (0)1252 373000 • [email protected] • www.paa.co.uk
Solution11XL document manager
For more information contact Mike Collins: +44 (0)1252 373000 • [email protected] • www.paa.co.uk
Solution11XL system audit trail
For more information contact Mike Collins: +44 (0)1252 373000 • [email protected] • www.paa.co.uk
Implementation - your choice?
• Network implementation Server PC (files copied to server at install time) Clients register through server
• Workstation implementation Server and client on same PC
For more information contact Mike Collins: +44 (0)1252 373000 • [email protected] • www.paa.co.uk
Deliverables
• Supply Solution11XL on CD To be deployed on a single server for network
access
(clients register with server or deployed on workstation)
• Comprehensive integrated service• User training and support• Documentation and validation protocols • User manual • IQ and OQ protocols (for purchase) • URS Word format (for purchase)
For more information contact Mike Collins: +44 (0)1252 373000 • [email protected] • www.paa.co.uk
Specifications• Solution11 XL is a secure add-in for Excel• Provides cell level provenance for all data• PC hardware requirements same as Excel• Complete Security and Protection environment for Excel files • Suitable for Excel 97, 2000, 2002, 2003• Easy installation – set up in minutes over a network• Licensed for number of concurrent users on network • Also deployable on workstations• Simple and intuitive to use• Spreadsheet data and system audit trails (data/activity/events)• Export encrypted audit trails to plain-text files • Unrestricted use of templates and macros• Unique Solution11 XL Manager for System Administrators and
Supervisors• Unique Snapshot facility to convert Legacy documents to Quality
documents• 256-bit AES encrypted security for Audit trails, E-signature, user
profiles etc • Unrestricted use of templates and macros• Unique export / import facility for reviewing, and electronic
signing offsite• Unique archiving facility - encrypted zip files (freeware reader) • Full development life-cycle documentation
+44 (0)1252 373000 • [email protected] • www.paa.co.uk
Process Analysis & Automation Ltd • Fernhill Road • Farnborough • Hampshire • GU14 9RX • UK
Fast track to 21 CFR Part 11 compliance with Microsoft® Excel
Interested?email [email protected] for a personalLive web demonstration!
