S4BT CONSULTING

Quality & Regulatory

We offer highly specialised consultancy services for manufacturing companies and Life Science affiliates in the areas of Quality Assurance & Compliance, Quality Control, Lab, Data Operations & Regulatory Affairs.

We pay particular attention to:

  • Collaboration with multi- and cross-functional teams
  • Management of team conference calls and face to face meetings
  • Quality of the documentation produced
  • Spreading a quality culture
  • Respect for client timelines
  • Integration with the in-house team
The service in detail

Quality & Regulatory Areas

Quality Assurance & Compliance

In the Quality Assurance & Compliance area, we offer consulting services for:

  • Deviation management, CAPAs
  • Change Control Management
  • Claim Management
  • Audit management and support
  • Management and review of procedures
  • Provision and management of training and re-training for the qualification of personnel
  • Drafting of protocols and reports
  • Product Quality Review
  • Management review
  • Mock recall
  • QAA revision

QA on External Manufacturers

We supervise the Quality Systems of External Manufacturers.

In particular, this comprises:

  • Drafting periodic reports on the performance (KPI) of External Manufacturers
  • Preparation and review of documentation (e.g. Product Quality Reviews, investigative reports of process deviations and complaints, change controls, CAPAs)
  • Drafting and periodic review of quality agreements with External Manufacturers.

Quality Control

In the field of Quality Control, we offer consultancy to Life Science companies for:

  • Support with chemical analyses
  • Support with microbiological analyses
  • Development and validation of analytical methods
  • Stability studies
  • Analytical troubleshooting
  • Writing protocols and reports
  • Drafting of documentation for quality control laboratories in the related systems

Data Operations

We offer consulting services for:

  • Management of requests to create, modify or deactivate finished and semi-finished product codes;
  • Management of requests and creation of new Customer and Vendor master data;
  • Management of activities for the introduction of new products (test execution, management of requests for the creation of new codes, creation or modification of codes, flow monitoring of regulatory data collection for material approval);
  • Periodic monitoring of the state of completeness and approval of material codes for New Product Introduction (NPI) in accordance with the launch timing;
  • Creation or modification of SAP objects related to the Global Supply Chain

Regulatory Labelling & Artwork

We support customer companies in work related to regulatory labelling and artwork.

In particular, this comprises:

We coordinate the text translation and labelling process in multinational contexts with highly specialised consultants in regulatory affairs and artwork management.

our experience

Some of Our Projects

Troubleshooting: Distillery, Water Treatment, Process Laboratory

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COMPLAINTS

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

AUDIT

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