The service

Process, Packaging & Cleaning Validation

We offer an innovative outsourcing service providing Process, Packaging & Cleaning Validation activities for pharmaceutical companies.

The service includes:

  • A team with a variable structure (in terms of number and seniority) according to the client’s needs
  • A Senior Consultant Project Manager, with several years of experience in the field, leading the team
  • A proprietary digital tool for enteringrequests, monitoring the assigned activities and project reporting.

The service can be customised by the client, who can also request the support of individual resources according to their needs.

S4BT Projects - Hold Time Validation
S4BT Process, Packaging & Cleaning Validation

Activity Details

  • Drafting of protocols and reports
  • Activities in the field (shop floor)
  • Sampling
  • Supervision of manufacturing, packaging and cleaning processes for the execution of protocols
  • Statistical processing of analytical and process data for the drafting of reports
  • Process and Cleaning Validation impact assessment for the introduction of new products and equipment and revamping of production areas
  • Validation Master Plan updating and subsequent coordination of the validation activities
  • Updating of cleaning procedures (Cleaning Validation)
  • Drafting of Master Batch Records for pre-validation and validation batches
  • Review of the process forms and of the batch records for pre-validation and validation batches
success stories

Results obtained in just one year
by one of our clients

our expertise

Some of Our Projects


Why choose the S4BT Validation Service?

You save on labour costs and resource training as well as on infrastructure
You increase efficiency thanks to the expertise and support of experienced and qualified specialists
You can focus on the core business and regain capacity
The risk is borne by the supplier
You can monitor activities in real time with a digitised workflow and extract useful data and reports
You can customise the service with a team of variable composition and a Project Manager always present
Total shift coverage 24/7, 365 days a year, on request. So you never stop production
Internal network of multidisciplinary skills for an integrated approach, with the qualification of plant, systems and utilities

What they say about us


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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