SAFETY & COMPLIANCE SOFTWARE
DIGITALISATION INCREASES GxP (GOOD PRACTICE) COMPLIANCE Digitalisation can also help better support industry standards and protocols such as GxP required for pharma, medical device and food manufacturing to ensure products are safe, effective and useable. GxP refers to ‘good practice’ guidelines,
where (x) is the discipline
e.g..food manufacturing. These practices are shaped by regulatory requirements to create a knowledge bank that determines how outcomes are achieved and quality requirements are upheld. Strict adherence to these standards is essential if you are to continue to operate. To be compliant with GxP you need to specify,
document and log every critical action made by each employee in the development, manufacture and delivery of a product or project by every employee and in a way that is auditable – if it is not documented, it did not happen. With WorkfloPlus you can facilitate ‘good
practice’ as it provides the right ‘tools’ to deliver visibility and accountability right across your operations by ensuring your processes are always ‘fit for purpose’ and there is no variation in product quality. Forward-thinking Bayer Pharmaceuticals is
deploying WorkfloPlus with HMT headsets from Realwear to help streamline and manage its production change over process, in what is a highly regulated market.
Forward-thinking Bayer Pharmaceuticals is deploying WorkfloPlus with HMT headsets from Realwear to help streamline and manage its production change over process
FEATURE
Drug manufacturing operations require regular
cleaning and change overs between each batch, by using WorkfloPlus it allows this procedure to be taken in a constant and timely manner, to help minimise “down-time” for greater cost efficiency, while at the same time it provides thorough audit checks that satisfy GxP compliance better than any paper ‘tick-list’ could deliver.
SUMMARY Most industries face similar risks, but knowing more about how regulatory compliance issues may occur and the consequences of failing to
manage them quickly and effectively, will enable you to keep in business and avoid being at risk of fines. Firms that digitalise will be able to consider
each new compliance requirement based on their priorities and the volume of work required. This means that you can get ahead of those competitors that still rely on manual, time- consuming paper-based methods. The value of digitising compliance and risk should not be underestimated.
Intoware
www.intoware.com
INDUSTRIAL COMPLIANCE | SPRING 2021
21
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