How do you ensure a reliable supply of ultrapure water (UPW) for quality control (QC) laboratory processes while maintaining confidence in your validation?
This blog explains why our PURELAB® Pharma Compliance package can solve both challenges – providing a complete, tailored solution that's easy to implement and use.
What is PURELAB® Pharma Compliance? 
PURELAB® Pharma Compliance is a comprehensive package combines three key elements: purification equipment, software, and qualification documentation – all customized to your lab's specific requirements. By selecting the right combination of options, it has the potential to streamline your daily ultrapure water delivery and simplify your purified water validation 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. Whether your laboratory is large or small, we can meet the needs of all laboratories operating under the validation conditions stipulated in either GLP, GMP and GDP.
2. Intuitive Software That Ensures Regulatory Compliance
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Our intuitive software ensures your chosen PURELAB® equipment integrates seamlessly into your lab without disrupting water supply or quality. Once in place, the PURELAB® Pharma Compliance delivers comprehensive functionality: admin functions, security and data integrity capabilities, password accessibility, audit trail procedures and permissions. All of these meet the global regulators best practice for data management following GMP standards, and provide the evidence required to meet FDA and EU standards for digital record keeping.
3. Validation support for every need
Our flexible services offer different levels of purified water validation to match your specific needs. Whether you simply want a water dispenser system, require GLP validation, or need full FDA 21 CFR Part 11 compliance for your laboratory – we have you covered.
As an added benefit, 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.
Your Complete Solution for QC Laboratory Excellence
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 select the right solution for your current needs and future plans. Want to explore your options? Contact our team for a consultation or more information about PURELAB® Pharma Compliance.
