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We understand that protecting patient and consumer safety is considered in everything our customers do. GxP is a general abbreviation for the "good practice" quality guidelines to ensure products manufactured and distributed by regulated industries are safe and meet their intended use. GxP requires manufacturers of medical devices, pharmaceuticals, cosmetics and certain chemical related products to implement and demonstrate adherence to appropriate knowledge, practice and processes that underpin a quality driven, risk-based approach. Kallik helps heavily regulated industries implement and maintain robust quality systems and processes for labeling to stay compliant with GxP regulations and Good Manufacturing Practice (GMP) principles and guidelines.

How does Kallik support GxP compliance?



Kallik is committed to ensuring we meet the most rigorous quality standards. We are an ISO 9001: 2015 certified organization, with a full and robust quality management system covering every aspect of our software development and support processes. You can find out more about Kallik’s approach to Quality, here.




Validation is not an afterthought - it's an integral part of our quality assurance process.Validation of computerized systems is a non-negotiable requirement enforced by regulators such as the FDA, EMA, TGA and HS-SC. Kallik eases our customer’s burden of compiling with GxP computerized systems validation by baking in OQ/IQ validation as standard into every single release of  Veraciti™ ensuring that industry standard GAMP 5 guidelines are adhered to at all times. Our implementation teams understand how important GxP validation is for our regulated customers and are experienced in deploying Veraciti™ in a way which is compliant.




For our life sciences customers, it is critical that any digital signatures or approvals are compliant with the rigorous standards expected by the regulators.  Veraciti provides complete compliance with FDA 21CFR Part 11 and EU GMP Annex 11e-signature requirements. You can find more detailed information about how we do this here.

Work with a software provider who puts quality first

Customers in the life sciences industry put their trust in Kallik every day to deliver a compliant software solution from day one and ensure that compliance is maintained each step of the way.  Veraciti offers many other benefits beyond compliance.

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