Healthcare


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