Quality Assurance & Compliance

We offer highly specialised consultancy services for manufacturing companies and Life Science affiliates in the areas of Quality & Compliance, Audit Management and Data Operation.

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

Il servizio in dettaglio

Quality Assurance & Compliance

INTERNAL & eXTERNAL QUALITY ASSURANCE & COMPLIANCE

Deviation management and CAPA
Change control management
Training and Documentation management
Complaint management
Data and workflow analysis
Risk Management
Quality Monitoring
Batch Record Review
Data Operations

INTERNAL & EXTERNAL AUDIT MANAGEMENT

In our team, we have Lead Auditors who are certified to conduct and manage audits.

QUALITY ASSURANCE ON THE FLOOR

The service in detail

Quality & Compliance Area

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 External Manufacturers

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.

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

our experience

Some of Our Projects

Issuing Certificates in electronic format

Process Deviation Management, Change Control, CAPA

Troubleshooting: Distillery, Water Treatment, Process Laboratory

Issuing Certificates in electronic format

Process Deviation Management, Change Control, CAPA

Troubleshooting: Distillery, Water Treatment, Process Laboratory

OUR CLIENTS

What our clients say

I can confirm that the work of the S4BT consultants I worked with was excellent. Excellent responsiveness to our requests and the ability to connect with the various stakeholders. For these reasons I feel extremely satisfied.

CLIENTS