Healthcare, Pharma, Medical & Food
Exploring the jungle of regulations
Almost no other sector is as strictly regulated as Pharma, Medical & Food. The software used in medical devices and for manufacturing medicines must meet stringent safety requirements. SQS is fully acquainted with the quality standards and other requirements imposed by supervisory and regulatory authorities – and works with customers to ensure their compliance.
In the Pharma, Medical & Food sector, national and international supervisory authorities specify exactly what quality standards must be met by medical devices and the associated software. SQS therefore supports its customers with all necessary measures – such as verification and validation measures, testing, and efficient project and configuration management – in order to guarantee that the software used meets the high quality and safety requirements.
The services provided by SQS in a large number of projects to date include:
- Software and system validation in line with international industry standards
- Introduction and optimisation of quality management systems in accordance with GxP, ISO 9001, DIN EN 13485 or FDA specifications
- Completion of internal and external audits
- Creation of all required documentation, such as SOPs, validation plans/reports etc.
- Systematic test case specification and test management, execution and automation
- Selection of efficient test procedures and software
- Establishment of requirements management
- Provision of training on software quality management and testing
The customer benefits at a glance:
- Manufacturer and product-dependent advice, service and training from one source
- 27 years’ experience in software quality assurance and system validation
- Specific industry expertise in the approval and licensing of medical systems
- Extensive audit/assessment experience
The following case studies from the pharma, medical & food industry are available for you to download:
- Download Case Study GlaxoSmithKline (PDF) Download
- Download Case Study Princes (PDF) Download
- Download Case Study Sectra (PDF) Download
Managed Testing Services
A close focus
on core business
Software testing as a ma-
naged service takes much
pressure from IT budgets
and business departments.
If required SQS also offers
Managed Testing Services
in an on-site-/offshore framework.
Innovations in Teamcenter testing
Siemens PLM
SQS specialises
in testing and quality
management of
Siemens PLM
products such as
Teamcenter.
