• Validation Strategy
• Validation Planing
  • Validation Plan
  • Validation Master Plan
• Validation Management
• Validation Methods and Engineering
• Compliance Management
• Compliance (Project-) Coaching
• Coordination of Projects/ Direction of Validation
• IT-QA / QMS / SOP’s

• CSV Projects
  • Software Systems
  • Hardware Systems
• CSV for Pharmaceutical Facilities
• GAMP Periodic Review
• System-Migration/ GMP Data Integrity
• System Replacement under GMP
• Storage-/ MFR-Systems
• ERP-System Validation / Detachment
• SE Projects / with GAMP5 CAT.5

• GAP Analysis
• GAMP-5 Conformity
• Data Integrity – Compliance
• (GMP-) Data Migration
• Hardware- and Data Processing Qualification
• ERP System-Validation
• SOP and Procedure Specifications
• IT-SOP Computer Validation
• SOP IT-Infrastructure-Qualification
• System CSV / Automation / Engeneering

• URS – User Requirement Specifications
• GMP – Process Design & Optimising
• Development of the Data-Flow-Proces
• Process Platforms for ERP-Systems
• Concepts for Laboratory Systems

• Compliance Status-Analysis
• Preperation for Inspections
• Monitoring of Inspections
• Vendor Audit
• Selftinspection
• CAPA Management
• Follow-Up Services / 483 Follow-Up

• IT (FDA) Regulatory Compliance
• FDA Remediation / Consent Decree
• DI – Data Integrity Remediation according to Part-11
• 21 CFR Part 11 and EU Annex 11: Comparison
• Quality Management System and 21 CFR Part 820
• FDA (IT-) Inspction Preparation
• FDA 483 Follow-up Service
• Projects

Engineering Support for CSV and Data Integrity
Exploit savings potentials in engineering

• Computer System Validation for plants and equipment
• Automation Standard for Equipment CSV:
  • Specifications based on Comparison with Part-11: Annex-11
  • IQ and OQ Tests in standard procedure
  • Supervisor Excel overview of all Laws and Measures
  • Savings of 50 % of working time for URS and validation by Standards
  • Savings in Risk Analysis (except for certain Part-11 parts) through Standards.

• Performing Data Integrity on Facilities / Equipment / IT
• Provide Part-11 Compliant Analysis Tools
• Data Integrity GAP analysis (with Part-11) on Pharmaceutical Plants
  • Data
  • Processes (IT Processes) (data flow charts)
  • Hardware (IT)
•  Project charter for the DI Project
  • Development also Ouality-Charter for FDA Inspections
• Optimization of data flows and IT processes on the plants
• Risk Assessment and Measures / Actions

• Validation of IT-supported (Software) Production Systems (e.g. LabX Server)
• SOP for plants CSV (according to GAMP©-5)
• Integration of SAT and FAT into the GAMP©-5 V model
• Integration of CSV and the GAMP©-5 compliant procedure for Automation Equipment
• PLC control
• Monitoring

AvexorTec© does not perform qualification of complete Automation Equipment

• Implementation of complete LIMS Projects
• URS and Specifications for System Selection (and DQ Phase)
• Qualification of laboratory robots, process control systems
• LIMS system implementation – also 3rd party systems with SAP

• LIMS systems conception URS, GAP analyses
• LIMS (CSV) validation / qualification
• GAMP©-5 Konformity
• Laboratory Pocesses and Procedures:
  • Reorganization of laboratory GMP processes
  • Reorganization of Qualification / Templates DQ, IQ, OQ etc.)
  • Creation and / or Reorganization of (Laboratory) SOPs
  • Optimization of Qualification / Validation for Laboratory Equipment / Systems
• GxP / GMP Data Management of Laboratory Systems / Laboratory Server
• Coaching of laboratory teams for Qualification / Validation