Compliance and Audit Support

The word compliance for many, is the sturdy backbone of quality and safety. For some, it can seem like a daunting gauntlet of regulations and expectations.

At QiSOFT we see compliance not just as a hoop to jump through – but the very essence that ensures products are safe, reliable, and up to the mark, maintaining the delicate trust between you and your customers.

Audit Readiness

Quick and easy access to datato support internal & external audit requirements

With real-time electronic data capture and record keeping, robust specification management, effective management of non-conformance and corrective actions, comprehensive document management (standards, instructions and protocols) and thorough traceability you are always audit-ready with QIS.

ISO 9000 / 9001 Support

Drive consistency & improve productivity with inbuilt process management tools

The document control and process management tools in QIS are designed to streamline, automate and integrate your quality processes. Automating the control of essential documentation required for maintaining quality standards such as SOPs, Specifications, Test Plans, Risk Management can help maximize profits and customer satisfaction.  

21 CFR Part 11

Supporting strict requirementsfor compliance based sectors

Security in setup, data protection, digital signatures, controlled workflows or procedural flows can ensure you follow all requirements for electronic data capture and record keeping. Multi-level security access to all routines and all production documentation, supported by full audit trail and comprehensive version control and archiving in line with production, are in-built and cannot be bypassed.

Risk Analysis

Easily access templates forFMEAs, HACCP, Control Plans and more

These are common tools that are used to predict and/or confirm when corrective action is needed, based on inspection and data collection. QIS makes them easy to set up and access any time. 

Corrective and preventative action 

Mitigate risk andimprove your processes

Digitizing these typically paper based procedures, makes it easier for operators to take the appropriate steps when responding to, or in prevention of a non-conformance. CAPA forms can be customized to include all relevant checks, the required order in which steps should be taken and digital signatures for sign off.

To request further information or schedule a tailored demonstration, please complete this online inquiry form.


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