About

Goldplate

Goldplate is an on-line, always available suite of applications that provide organisations, private and public, with a proven solution for environmental monitoring and reporting of clean spaces. These spaces are found all over various industries, including public health, pharmaceutical, electronic, and food industries, to mention a few. Until the release of Goldplate, no efficient solution was publicly available to manage the data needed to ensure the standards required to operate these facilities were met.

History

We asked Ian Clarke, Senior Partner in Goldplate to tell us about the history of the Goldplate applications

"I was privileged enough to work in a hospital pharmacy which held the rather cynical motto: ‘What’s in it for the patient?’ In this age of ever increasing legislation, procedures and scientific complexity, I always felt that this single statement (albeit somewhat humorous) did serve us well. Whatever we do, we have to remember why we are doing it.

Manufacturing pharmaceutical products is an error-prone and complex business. The aim of good manufacturing practice should never be forgotten, or hidden away in the intricacies of its execution. We must make safe products, free of contamination by using the best methodology and monitoring available. We fully document and record our processes along with their results to demonstrate best practice has been observed and, where indicated, improvements can be made.

We are fortunate to have at our disposal a plethora of good guidance from many sources – the Royal Pharmaceutical Society being the prime reference point and I would urge you to read and understand the RPS – ‘Quality Assurance of Aseptic preparation Services: Standards Handbook edited by Alison M Beaney.’ In it you will either find or be pointed to every aspect of safe practice, preparation and monitoring.

Hospital pharmacies – and other manufacturing sites are becoming increasingly busy and sometimes there is a temptation to ‘put things off’ or patch together something in the expectation of satisfying the requirements of GMP. This is not a criticism; pharmacists and technicians trained for their clinical and scientific skills can hardly be pilloried for the complex task of preparing a system which satisfies the intricacies GMP as well as providing the tools necessary for monitoring and reporting.  The external auditor’s arrival may be a sobering visit, deficiencies will surely be identified and improvements recommended or required. In designing a monitoring system one could be forgiven for being overwhelmed by the sheer diversity and quantity of data that is collected – and more importantly putting that data to good use takes specific skills, and these are not always found in a clinical setting. Building a good system, even if there were the time to develop it would be no small task.

I have seen spreadsheets used as the tool of [quick] choice for recording monitoring data. In the short term this could be a viable option – but the pages rapidly grow into an unwieldy beast – the ability to change  as new requirements are found become difficult or impossible to deliver. What started out as a simple get-you-by solution becomes another problem in itself. I cannot recommend the use of spreadsheets as a place to store data – however they do very much have their place for presentation purposes, for example the manipulation of graphical data by customised pivot charts. The important point is to keep the data safely separated and in a format that will allow further painless development as requirements evolve.

Our prototype tool for an Environmental Monitoring Software was written and tested in 2016. Since then the team has evolved Goldplate into a highly secure integrated web-based solution which allows you to customise according to your needs and monitor your department’s performance. You can easily define your own groups and their plates – the out-of-specification CFU limits, and even pre-limits (to be investigated even if the fail limit is not reached). Recording CFUs and laboratory data – to genus / species level where appropriate. The database forms the source of an integrated suite of reporting tools (charts, textual, dashboards) so you can continually and instantly monitor your departments manufacturing health – identity trends and produce proof of good manufacturing.

Your department can work on Goldplate at any time – your data is safe, secure and protected, but it is your data and you can download it at will if desired [security protected]. Our goal was to create a professional grade product that is easy and pleasant to work with which will save you time effort and frustration – so you can get on with the ‘real’ work!"

To find out how you can utilise Goldplate in your organisation, contact us today to arrange no obligation demo account.