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Data Integrity Assessment Checklist

Does your company operate in full Data Integrity compliance? Does it comply with all the legislative provisions and guidelines issued by the regulatory bodies?

The S4BT Data Integrity Checklist will help you understand the extent to which your company is working in compliance. Prevent observation risks. Fill in the form and download the checklist.

Once completed, you can discuss it with one of our consultants in a one-hour meeting. Free of charge and with no strings attached.

Computer System Validation and Data Integrity

IT & Computer System Validation (CSV)

S4BT has twenty years of experience in Computer System Validation (CSV). We validate computerised systems for new installations or upgrades in compliance with the regulatory framework and guidelines, in particular 21 CFR, Eudralex Vol. 4.

Network monitoring tools, firmware, COTS, laboratory computerised systems, LIMS, ERP, SCADA, spreadsheets, custom software, etc.

We provide the customer with a complete documentary package that satisfies the most critical regulatory conditions.

We also provide consulting for:

  • 21 CFR part 11/EU Annex 11 Gap Analysis
  • Supplier Software Selection
  • Drafting of the Administration SOP
  • Periodic Audit Trail Review
  • Network infrastructure qualification

Data Integrity

S4BT has been working in Data Integrity for several years, and offers a consulting service based on the latest methodologies for implementation of a corporate data integrity plan, starting from a careful analysis of the compliance of the systems managing electronic and printed data with the principles of data integrity.

We support all assessments of systems (with a preliminary check on compliance with 21 CFR Part 11/Annex 11) and document packages in relation to GMPs.

We also bring our knowledge and experience of Data Integrity to the classroom. We provide training courses tailored to all company levels, from basic training to advanced level, mainly for people involved in data governance and quality management.

Data Integrity Assessment

Some of our clients

Data Integrity Assessment

S4BT

S4BT – Solutions for Business & Technology – is a company that has been working in the Life Science sector for over 25 years and provides know-how and specialist solutions to companies all over the world.

The company is organised into two divisions:

Specialised consulting in the areas of Quality, Engineering, Validations and Project Management

Product, which develops software solutions for the Digital Transformation of companies in the sector. More specifically, PRAGMA-WFM is the Workflow Managementplatform we have designed and developed to ensure the digitisation of business processes in compliance with FDA and cGxP guidelines.

www.s4bt.it

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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

Download the in-depth study

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

Download the in-depth study
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