Overview

• The Company
• Products and Services
• EurothermSuite Products
• 21 CFR Pt 11 Products
• TickIT certifcate

Audit

• Audit Blank based on GAMP4 Appendix M2
• 21 CFR Part 11 Audit Report for Eurotherm 5100V/5180V, Version 3 (1,184KB)

Applications

• Fermenter
• Stability Monitoring
• Freeze Dryer
• TimeSync & MKT

21 CFR Part 11

• Products for 21 CFR Pt 11
• 21 CFR Pt 11 Final Rule
• 21 CFR Pt 11 Final Guide
• 5000B and 21 CFR Pt 11
• 51x0 and 21 CFR Pt 11
• T800 and 21 CFR Pt 11
• OPS and 21 CFR Pt 11
• 5000 and ERES
• T800 and ERES
• OPS and ERES
• TimeSync & MKT
• 51x0 FDA Meeting
• OPS and T800 features
• White Paper On Remediation Strategies

Gamp 4

• Life Cycle
• 5000: URS
• 5000: FDS Cat2
• 5000: IQ Spec Cat2
• 5000: IQ Test Spec
• 5000: IQ Test Result
• 5000: IQ Acceptance
• 5000: Fault Report
• System: QP
• System: FS
• System: HS
• System: HATS
• System: SDS
• System: SMS
• System: SMTS
• System: SATS
• System: Code Review
• System: Config Plan
• System: Config Envrm
• System: Config Schedule
• System: SW Release

Batch S88

• S88 Intro
• S88 Applied

Press Release

• The 21 CFR Pt 11 Impact
• Networked Audit Trail
• Process Validation
• S88 Applied