• Consulting

GxP Compliance and Computerized System Validation (CSV)

The safe way to sucess with Significon

The Challenge

Compliance with increasing regulatory demands, particularly in the life science industry, represents a very special challenge. Cost pressure on the one hand and rising quality requirements on the other side are an almost insurmountable challenge and a heavy burden on the organization.

Perfection is finally attained not when there is no longer anything to add, but when there is no longer anything to take away. (Antoine de Saint-Exupéry)

Compliance Management as success factor

Compliance Management is not only the fulfilment of the requirements of the statutory regulations; it is, as part of the product and process quality assurance and company knowledge management, an important success factor. Those companies that can define and implement effective compliance strategies generate a distinct competitive advantage.

We support you!

The Compliance Management knowledge of Significon’s consulting team spans from
Compliance strategy to implementation of GxP-compliant business processes to satisfy the statutory requirements. An integral part is the validation of computerised systems and the IT service management processes to support and maintain the valid state of the systems. This is a core element of GxP-compliant IT operations as well as the GxP-compliant implementation of SAP systems.

The aim is to fulfil the regulatory requirements more efficiently through permanently liveable processes from both an organisational and business point of view."

In order to avoid duplication and inefficiencies, a harmonized view of all relevant requirements and regulations such as FDA 21CFR, EU Annex 11, and/or MPG, are taken into account. The primary goal is to integrate the quality assurance measures in the organization and its processes, to avoid acceptance problems. The procedures are based on proven standards and methodologies such as GAMP®5 and the V-Model.

Best Practice Solutions and Templates ensure a quick and successful delivery

In projects, we can provide “Best Practice” proven templates, methods and content to help achieve a quick state of “Inspection Readiness.”

Significon’s consultants have experience in the validation and qualification of IT- infrastructure, bespoke applications, from simple Excel worksheets or Access databases, up to standard application software, such as

•    ERP systems,
•    document management systems,
•    production systems, such as MES,
•    Quality / laboratory systems, LIMS
•    R & D systems,
•    IT Infrastructure system, such as servers, networks, databases, etc.
•    Pharmacovigilance systems,
•    maintenance, facility and warehouse systems
•    etcetera

Significon AG

Wilhelm-Theodor-Römheld-Straße 30
55130 Mainz / Germany
Phone: +49 (0)6131 - 302919-0