Quality Systems for Laboratories

Quality Systems for Laboratories

The reliability of equipment, accuracy and the integrity of analysis results are of great importance in each laboratory. We support you with our permanent endeavour to comply with all regulations by making use of solution-oriented, multidisciplinary consultants.

Together we look after the installation, qualification and proper operation of your lab equipment and information systems. Taking the regulations into account, we support robust, repeatable, accurate analysis methods according to a risk-based approach. Thus we contribute to the safety of consumers and patients.
 

Know-how and best practices

When you turn to Agidens, you have access to multidisciplinary teams with experts in the field of informatics, quality assurance, technicians, project managers and scientists.
 

Lab assessments

We carry out assessments to comply to various quality systems:
  • GxP assessment
  • Data integrity assessment
  • ISO 17025 assessment
  • 21 CFR part 11
  • Lean lab assessments (value stream mapping)


Lab validation services

Our specialists support you with various topics:
  • Equipment validation
  • Process validation
  • Method validation
  • Cleaning validation
  • Thermal validation
  • Computerized System Validation (from stand-alone system over spreadsheets to full LIMS package)

We hereby provide the following documents:
  • User Requirements, purchase specifications
  • Validation plan
  • IQ, OQ, PQ
  • Protocol, test scripts, report per system
  • Configuration management
  • Device and lab procedures

In addition, Agidens also provides training on lab equipment qualification, data integrity, etc.

Contact a specialist

and get an answer within
three working days

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