Spraytec Regulatory Compliance

In an ever more regulated environment, it is important that analytical instruments and procedures conform to current regulations.

The operation of the Spraytec is consistent with the ISO 13320-1 directive which sets out the general principles and requirements for droplet sizing using the technique of laser diffraction.

Security features are built in to the software as standard to enable an administrator to define the exact access rights to the software of individuals or groups. This function can restrict the rights to change SOP's or delete records for example.

For users operating in an FDA-regulated environment, an optional software enhancement is available to provide users with the technical capability of achieving complete 21CFR Part 11 compliance, once the required procedural and administrative controls are in place. In addition, the Spraytec system and its software are supported by a full validation package including IQ/OQ's.