A current article in Cleanroom Technology, entitled Environmental monitoring meets sterility testing, discusses ‘quality control, is of the utmost important; requiring a combination of tests; protocols and validated processes to minimise risk to public health’.
It further states that ‘an Environmental Monitoring programme must focus on collecting data consistently and accurately if it is going to mitigate risks effectively. If contamination occurs, then the data gleaned from the Environmental Monitoring becomes critical in the subsequent investigation’. This is where WJP Software Ltd’s Microbiological Reporting System (MRS) has been developed and supports the aseptic labs by offering them a standardised and easy to use software solution which offers an accurate way of collecting data in real-time. Furthermore, it allows users to have a continuous and ongoing approach which is time effective and reduces the lead in time as it offers a real-time approach between input and reporting.
The software allows users to make evidence-based decisions through the ability to narrow down on the high number of touchpoints offering users a route cause analysis. For example, one of WJP Software clients sees over 250,000 plates per year so being able to narrow down on these large number of touchpoints is hugely important. The other option is to have to go through them manually via paper or an Excel spreadsheet which is time and resource consuming. Furthermore, under the MHRA data integrity guidelines using a paper-based system doesn’t offer an audit trail, meaning potential changes could be made. The MRS software is auditable and offers a validated system. As, the article reports ‘an Environmental Monitoring programme must be an ongoing, continuous exercise as such an approach significantly reduces the length of an investigation because it can help pinpoint with precision the areas at the highest risk’. Wayne Goddard, Quality Control Manager at Stockton Quality Control Lab said “The key to any environmental monitoring programme is that it provides a holistic view of the manufacturing environment. When excursions occur within this programme it is essential that the person investigating has all the relevant data to hand. By using an electronic system such as MRS it allows the user to quickly focus in on relevant trends and patterns within the data and therefore establish potential root cause(s).”
The article further states ‘a continuous Environmental Monitoring programme will deliver far better insight since the best defence is a good defence’. The MRS system has been developed to allow users easy access to the data whenever they want it. This supports the idea that annual audits can be easily achieved, or if users wanted to do they could carry out more regular checks. This is done through a data in, information out system, meaning a user only needs to enter the data once and it can be reported on through multiple channels. Laura-Jane Keating, All Wales Specialist Pharmacist QA/QC (Regional QA Wales) from NHS Wales stated ‘the MRS system provides us with easy access and added assurance when reviewing and auditing both licensed and unlicensed aseptic facilities within NHS Wales’.
The MRS system provides service leads, alongside internal and external auditors unambiguous and relevant information in a standardised format meaning it is easy to gain full annual audit trail but also it has been designed to be aligned with the latest MHRA and GMP regulations.
If you would like to find out more about how our MRS System can help you ensure your data integrity in line with the MHRA guidelines, email email@example.com for a free online demo.
Published: 18/11/2019 Published by: Rebecca Proctor
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