WE UNLOCK POTENTIAL.

"Current changes require process adjustments. We help to create a tailor-made solution."

Jörg Erdmann
Business Director

Consulting

The manufacturer-independent consulting company Systec & Services serves international clients. In the regulated industries, we mainly help pharmaceutical clients, however we also advise clients in the medical devices, biotech, food, and cosmetics industries.

The experienced team of experts supports clients with:

  • Consulting and system selection
  • Program and project management
  • Onboarding management
  • Specifications
  • Process design
  • Documentation and validation according to GAMP®5
  • Software adaptation and interface development
  • Training
  • Go-Live-Support
  • Support during operation

Business Area Manager

Jörg Erdmann

Phone: +49 721 6634 357

Write an email
Download vCard

Download our Serialization checklist und discuss it within your project team. Use the checklist to examine and evaluate your Track & Trace project. So you have a quick overview of your current situation.

Downloads

Checklist Serialization Project

Checklist for effort estimation of a serialization project

Download (PDF, 601.98 KB)

On-boarding

Real-life example:

Requirements

  • Several production sites with several thousand generic products
  • Production and distribution for the German and European market
  • Connection of over 150 business partners and CMOs for FMD-compliant exchange of serial numbers and production reports

    Solution

    • Use of customized tracking tool
    • Suitable approaches for the respective IT solutions of the partners to be connected

    Realization

    • Pilot batch at each production site
    • Test items on both sides (MAH and CMO)
    • Planning and configuration of the gateways
    • Adaptation of the packaging design

    Results

    • Successful connection test between MAHs and CMOs
    • Comparison of stock keeping unit lists (SKUs)
    • Exchange of global and national trade item numbers
    • Verification
      • Tamper evident seal
      • Packaging design guidelines
      • Serial number format and IT specifications

    Validation Services

    Real-life example:

    Requirements

    • Development of a suitable quality management system (QMS)
    • Compatibility with FDA (Food and Drug Administration, USA) guidelines
    • Shortening of the process time of a vacuum drying plant for medical devices by 60%

    Results

    FDA-compliant quality management system

    • Traceability of process data
    • Detailed batch records
    • Dedicated interface
    • Integration and control of production plants

    Business Process Management

    Real-life example:

    Requirements

    • Document analysis and preparation of process description
    • Joint consolidation meeting of process description and approval
    • Definition of harmonized target process

    Realization

    • Joint review meeting with the companies and approval
    • Process-oriented and effective meetings thanks to Systec & Services Process Landscape™ 

    Results

    • Recording of the current processes within only 3 months  
    • Parallel initialization of the work on the target process
    • Completion of the work on the target process after another 3 months
    • Simultaneous fit gap analysis of the core system