QC Labs - The Three Ways Our New Compliance Package Can Help

How do you ensure a reliable supply of ultrapure water (UPW) for quality control (QC) laboratory processes and maintain confidence in your validation? This blog summarises why our PURELAB® Pharma Compliance package is the answer – providing everything you need in a tailored, easy to use combination of equipment and services. 

PURELAB® Pharma Compliance – what is it? 

The package consists of a highly effective combination of purification equipment, software and qualification documentation – all of which are tailored to your lab’s exact needs. By finding the right set of options for you, it has the potential to streamline and simplify your day-to-day approach to the delivery of ultrapure water and the subsequent purified water validation guidelines and processes. Through our trusted technology and services, we can offer support in three crucial ways:

1. The delivery of ultrapure lab water
 

The 18.2 MΩ ultrapure water is provided from a high quality engineered, reliable and easy-to-use system that’s been developed by our specialist team. Rest assured it will provide the required water quality when it’s needed, and in the correct volumes to support the QC tests necessary to validate pharmaceutical purity. We can meet the needs of all laboratories – no matter their size or scale – operating under the validation conditions stipulated in either GLP, GMP and GDP.   

2. Implementing smart and secure technology 

Our intuitive software means the PURELAB® equipment chosen will be able to integrate seamlessly into your lab with no disruption to water supply or quality. Once in place, the PURELAB® Pharma Compliance admin functions, security and data integrity capabilities, password accessibility, audit trail procedures and permissions all meet the global regulators best practice for data management following GMP standards, and provides the evidence required to meet FDA and EU standards for digital record keeping. 

3. A validation support portfolio 

Through our flexible services – we can offer different levels of purified water validation, from those who want nothing but the water dispenser system, to those needing GLP validation right through to those labs that require the latest FDA 21 CFR part 11 compliance. 

The added benefit is that both Installation Qualification (IQ) documents and Operational Qualification (OQ) documents are supplied as part of the standard package. Furthermore, purification and servicing processes support the requirements by USP643 and USP645 – the only accepted method of validation of TOC reading for any system - anywhere. 

So, the message really is - whatever the requirement – we can support you when it comes to maintaining compliance and any requalification. 

PURELAB® Pharma Compliance Package

Through our quality engineering and expertise, you can take advantage of a practical combination of equipment and services that have been optimised with a range of features specifically for QC labs. The PURELAB® Pharma Compliance package gives you an effective and compliant ultrapure water system – with the level of validation support you want. 

Finally, our knowledgeable team can help you find the right solution if you are unsure what’s best for your current or evolving needs.  If you want to read more or request further information about the PURELAB® Pharma Compliance package from our team, click here.