Health Care
Validation of computer-aided systems
SQS validates your software in accordance with the stipulations
of international industry standards, the legal GxP regulations,
as well the FDA guidelines. The quality assurance systems
used (compliant with ISO 9001, EN 46001 or EC GxP) are also
comprehensively evaluated. A significant component of validation
work is also the carrying out of risk and hazards analyses
as well as the implementation of risk management concepts,
particularly for medical products in compliance with EN 60601-1-4
and ISO 14971.
The pharmaceuticals and process
industries
Some of the services SQS provides to the pharmaceuticals and
the process industries are:
- Software validation in compliance with the requirements of international industry standards such as GAMP, NAMUR, AVP and EG GMP Guide Annex 15
- Evaluation of software quality assurance systems in accordance
with ISO 9001 and EC GMP
audit - Drafting of validation master plans and reports
- Testing data and information security in computer-aided systems in accordance with FDA 21 CFR part 11, signature law
Medical technology industry and
IVD
Some of the services SQS provides to the medical technology
and diagnostics sectors are:
- Software validation in compliance with the requirements of international industry standards such as ISO 9001:2000, EN 46000 ff., ISO 13485, EN 60601 ff. and ISO 14971
- Preparation for certification by a designated body
- Risk analyses and development of risk management plans
- Evaluation of software quality assurance systems in compliance with ISO 9001 and BOOTSTRAP
Document management
For all sectors SQS offers:
- Validation of electronic document management systems (EDMS)
- Drafting of technical documentation and approval documents
in the validation process for the approval of medical products
and the acceptance of systems engineering