Qualification and validation:
Your guarantee for a secure process. To the last detail

There's hardly a more sensitive area than packaging for medical products or pharmaceuticals,
since they have to comply with the highest security and cleanliness requirements.

Validation services from Multivac compliant to ISO 11607

We offer you a complete qualification/validation program. You can enjoy the security and
reliability of professional standard and regulatory compliant implementation. With new machines
as well as with the qualification of old machines.

Risk analysis / FMEA
With this method possible risks in the context of your Multivac will be systematically identified
and evaluated. – Qualification and validation belongs to the basic conditions of all further work.

Design Qualification (DQ)
• Project specific validation plan
• Duty book / functional specifications
• Hardware Design Specification (HDS)
• Software Design Specification (SDS)

Installation Qualification (IQ)
• Inspection of the equipment
• Comparison of planning documents with the installed condition of the finished machine

Operational Qualification (OQ)
• Test of product relevant components and component groups
• Test of machine specific software modules
• Error test log