Qualification & Validation

We prepare the documentation and carry out the activities you wish

We are experts in qualification & validation in the biopharmaceutical industry

The validation and qualification process can be a large and very complex part and often requires a lot of resources to perform. We start from your organization and work procedures and prepare a plan for the activities and documents that must be part of the validation/qualification of your plant, process or equipment.  We ensure a timely, easy and flexible delivery of the documentation for your plant, process or equipment, which also meets all authority requirements.

We can step in and support the user organization in all or parts of the qualification and validation phase described in the quality project model (QPM) below.

Quality Project Model (QPM)

Activities & documents

1. Planning & Conceptual Design

  • Preparation of User Requirement Specification (URS)
  • Conceptual Design
  • Preparation of Supplier Proposal (SDP)
  • Preparation of Validation Plan (VPL)
  • Preparation of Quality Management Plan (QMP)

2. Detailed design

  • Preparation of design documentation (P&I diagram, layout drawings etc.)
  • Preparation of FDS, HDS, SDS (Design Specifications)
  • Preparation of Requirement Traceability Matrix (RTM)
  • Design Review/Qualification (DER/DQ)

3. Manufacturing & Assembly

  • Receiving Verification Test
  • Factory Acceptance Test (FAT)

4. Packaging & Shipment

  • Packaging of the equipment
  • Shipment of the equipment to the customer facilities
  • Receiving & Inspection at site

5. Installation & Operational

  • Site Acceptance Test (SAT)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)

6. Performance & Validation

  • Performance Qualification (PQ)
  • Cleaning Validation (CV)
  • Process Validation (PV)
  • Preparation of Validation Plan Report (VPR)