Equipment, environment and utilities qualification

We offer a tailor-made consulting service for pharmaceutical companies, APIs, medical devices, biotechnology and pharmaceutical satellite activities.

We deal with instrument calibration, revamping projects, and qualification and re-qualification of equipment, systems and utilities with our own (LAT, SIT, EA) certified scientific instrumentation.

We handle the preparation of the qualification document package through the direct application of Quality Risk Management principles:

  • Validation Plan
  • User Requirement Specification and Functional & Design Specification
  • Risk Assessment and System Impact Assessment
  • Design Qualification (DQ) and Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols
  • Periodic re-qualification protocols
  • Validation report/Summary report
Equipment & Facilities Qualification
Equipment, environment and utilities qualification

Project team

Our consulting services include the implementation of ,periodic testing of qualification and requalification protocols and of manufacturing equipment, and support in the execution of FAT and SAT during commissioning. 

Thanks to our team of Qualification Engineers , we can satisfy the most critical regulatory conditions, ensuring full compliance with international guidelines and GMP standards, particularly those of the FDA and EMA.

PMP-certified project managers supervise the projects, ensuring their completion on-time and on-budget. We monitor the process and constantly update the client, to facilitate co-operation and  achievement of the shared goal.

Our twenty years of experience with SMEs in the sector have made us a reliable partner, capable of supporting our customers with high workloads, in preparation for inspections, or for support with skills.

Our experience

Areas and systems that we cover

  • Reactor
  • Dryer
  • Centrifuge
  • Crystalliser
  • Incubator
  • Reverse osmosis purification unit
  • Ultra-filtration purification unit
  • Dissolving and filtering unit
  • Filling line
  • Flask washer
  • Depyrogenation tunnel
  • Autoclave
  • Oven
  • Bio-decontamination Unit (VHP)
  • Component washer
  • Cold stores
  • Warehouse
  • Mixer
  • Granulator
  • Tablet press
  • Coating pan
  • Filling machine – Encapsulating machine
  • Blister pack machine
  • Autoclave
  • Component washer
  • Incubator
  • Oven
  • LAF hood and Bio Safety Cabinet
  • Refrigerator
  • Ultra Low Temperature Freezer
  • Stability chamber
  • Warehouse
  • Temperature-controlled chamber

Systems for the production, distribution and storage of:

  • Water for Injection
  • Purified Water
  • Pure steam
  • Process gas (compressed air, nitrogen, etc.)

HVAC systems and controlled contamination areas:

  • Unidirectional Air Flow areas (LAFs)
  • Environmental monitoring systems (EMS) for critical parameters
Equipment, environment and utilities qualification

Why choose S4BT?

Dedicated team of qualification engineers
Complete document package (ITA-EN) that satisfies the most critical regulatory conditions
Our own (LAT, SIT, EA) certified scientific instrumentation
Customer support during each phase of the system's “Validation Life Cycle”
Projects supervised by PMP-certified project managers
Risk-based approach based on Quality Risk Management principles
An internal network of multidisciplinary skills to optimise the computer system validation strategy
Full compliance with FDA and EMA regulations and guidelines and other specific standards
Our experience

Some of Our Projects


What they say about us


Request more information

Fill out the form and tell us your needs.
One of our consultants will contact you as soon as possible.


An aid to inspection work

Simplify the management of Complaints, from filing, through investigation, follow-up, judgment and final report.

The module is designed to provide step by step Quality Assurance support
in the implementation and supervision of the process and the assignment of tasks to the departments involved. The module supplements the CAPA procedure, which the user can open directly from the Complaints procedure.

PRAGMA-WFM documents and traces all activities and information in the Complaints process. In each phase, you can also attach files in various formats to support activities and investigations.

During inspection phases, the functionality dossier enables the real-time generation of a document that provides information and lists the activities of the process and related processes


Documents and traces activities

It simplifies the management of internal and external audits, from planning, through execution, to the management of remarks.

The module supplements procedures for handling CAPAs , Non Conformitiesand Change Control that the user can open directly from the audit to resolve the observations found.

PRAGMA-WFM documents and traces all activities and information of the Audit process. For each process step, it is possible to assign tasks to the people involved, and attach files in various formats.

Duringthe inspection phase, the dossierfunctioncan generate a document in real time which records the information and activities of the Audits and related processes