Pharma Microbial QC Systems Qualification

Get ready to start any PQ work in less than 5 days! This is what you can achieve, thanks to our ready-to-use Customer Validation Protocols and associated IQ and OQ services. Watch our videos to learn more about our validation packages for microbial testing systems and our comprehensive services portfolio dedicated to Pharma QC labs.

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Benefit from Our Validation Packages for Microbial Testing Systems

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Proven Protocols and Expertise to Qualify Our Products for Use in Your Testing Processes

cGMPs/cGLPs require equipment and test methods to be validated before routine use. This process can be time-consuming and may delay the start of critical QC procedures. Receive prepared protocols and have your new QC systems validated quickly and efficiently by our experts, saving time in the process. Our Customer Validation Protocols are now available in digital format for an optimized experience using our Val@M™ Application.

Reduced development time & cost for validation
Regulatory compliance and auditability
Decades of expertise in applications, regulations, and validation
Full digital validation workflow using our Val@M™ Application

Learn more about our Val@M™ Application and method development validation services.

After you have validated your QC testing equipment and method, we offer a full range of maintenance and service plans for the routine use of your equipment.

FAQs

What is the structure of a Customer Validation Protocol?

Our validation protocols are based on our internal product qualification test methods. These extensive protocols follow international guidelines such as EP/USP and GMP.

Validation Master Plan (VMP): Defines structure and responsibilities for qualification.
Installation Qualification Protocol (IQP): Verifies and identifies the system, verifies the system’s utilities, and checks operating environment requirements, equipment, and personnel preparation.
Operational Qualification Protocol (OQP): Verifies the system’s functionality (hardware, software, devices).
Performance Qualification Guidelines (PQG)

How can I order a Customer Validation Protocol?

To receive a quotation for a Customer Validation Protocol and associated on-site IQ & OQ service, please contact your local sales representative.

What kind of services can you provide for validation?

We have experienced and trained validation engineers who are skilled in assisting with Customer Validation Protocol implementation within the QC Microbiology laboratory, so the QC/QA Departments do not have to allocate resources. Technical training on your new system is also provided during the validation engineer's visit. In addition to IQ & OQ execution, we can assist with PQ consulting and execution services as well as advanced operator training. For more information, please contact your local sales representative.

How fast can the validation be completed?

Preparing the protocol on your own may require around 4 weeks of development, including research on applicable regulations, defining acceptance criteria, writing test methods, formatting, etc. You can save this time by using our ready-to-use Customer Validation Protocol.

The estimated IQ/OQ completion time for your own staff without a pre-written protocol is 6 to 7 weeks, and still 2 to 3 weeks using our Customer Validation Protocol. Our trained validation engineers will complete this work in 1 to 5 days on-site, depending on the type and number of systems. You just need to plan the slot with our coordination team in advance.

Discover our Validation Packages

We are more than happy to assist you and provide you with further information about our validation protocols and related services for your QC microbiology labs. Simply fill out and submit the form below.