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Sympatec provides a Validation Binder as an add-on to support installations in a validated (mainly pharmaceutical) environment. The Validation Binder contains all documents created during production, system integration and on-site installation.

Contents of the Validation Binder

Chapter 1:

Sympatec’s Validation Procedure

  • explanation of the procedure and the documents

Chapter 2:

Installation Qualification (IQ)

  • check of general operating conditions, including supplies and environment

  • verification of the proper installation of all delivered components, identified by their serial numbers

  • software validation by a check list of all installed files and WindowsTM registry entries

Chapter 3:

Operational Qualification (OQ)

  • check of the manual and remote controlled functionality, communication, and data evaluation

  • verification of the proper function of all delivered components

Chapter 4:

Performance Qualification (PQ)

  • check of the entire system under realistic operating conditions with the help of Reference Materials

Chapter 5:

Production Binder

  • all QA documents generated during the production of the system components

Chapter 6:

Production Operational Qualification (POQ)

  • mainly identical to OQ during validation on-site

Chapter 7:

Production Performance Qualification (PPQ)

  • mainly identical to PQ during validation on-site
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Sympatec's Quality Management
Validation