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Compliance is demonstrated at your site.

QaLyZa gives you the evidence. Here are the standards its applications are designed for, and what remains your responsibility.

Software alone does not make an organization compliant: system validation, your procedures and your infrastructure all play a part. QaLyZa provides the mechanisms and documentation to support it.

Standard by standard

  • GMP

    Good Manufacturing Practice

    GMP governs the processes of a pharmaceutical site. QaLyZa is designed so that each process has its own module, in one of the six applications.

  • 21 CFR Part 11

    FDA

    The US regulation on electronic records and electronic signatures. The six applications are designed to help you demonstrate compliance with it.

  • EU GMP Annex 11

    European Commission, PIC/S

    The EU GMP annex dedicated to computerized systems. Each application is designed to follow its principles, from validation to archiving.

  • GAMP 5

    ISPE

    The reference guide for validating a computerized system based on risk. QaLyZa is designed to make your validation easier, with supporting documentation.

  • ALCOA+

    FDA, MHRA, PIC/S

    The nine principles of data integrity, from “attributable” to “available.” Each application is designed to uphold them.

  • EU GMP Annex 1

    European Commission

    The annex dedicated to the manufacture of sterile medicinal products. The EMS is designed for the environmental monitoring it requires.

  • Other standards

    European Commission, ICH, FDA, AFNOR

    Annex 15, ICH Q9 and Q10, the FDA guidance on out-of-specification results, the FD X 15-140 standard: QaLyZa also draws on these texts, each in its own field.

What remains your responsibility

QaLyZa provides the evidence and the documentation; the demonstration itself takes place at your site.

  • System validation, for your own use.
  • Your procedures, and how they are applied day to day.
  • Your IT infrastructure.

The platform