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Life science software validation

Our life science software validation is offered by our partner, CompliancePath, an end-to-end health and life science compliance services provider. Anyone operating in these sectors requiring validation can receive independent assurance that your software works in the way you need it to.

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The FDA's draft guidance on 'Computer Software Assurance'

The FDA is set to release its upcoming guidance on Computer Software Assurance (CSA) in the coming months. This will be a change in regulatory approach from the existing 'Computer System Validation' (CSV). What do you need to do to get ready for this important shift? Discover our guide to find out more.

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The importance of software validation for your business

Software validation is crucial for life science organisations to provide assurance that your systems work in the way you need them to. It also ensures that you are compliant with key industry standards such as ISO 13485 and Good Automated Manufacturing Practice (GAMP).

A stable documented platform configured to your exact specifications

A tool that will perform consistently every time it is used

Verified user roles and security

Significant improvements in data quality and integrity

Decreased failure rates

Fewer recalls and corrective actions

Less risk to patients and users

Reduced liability to manufacturers

Q-Pulse QMS software validation

Q-Pulse validation provides independent assurance of your QMS, allowing you to configure it to your internal processes and systems. It saves a considerable amount of internal resources and dedicated time, allowing you to get started with Q-Pulse as quickly as possible in a compliant manner.

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PleaseReview software validation

Our validation service for PleaseReview gives you assurance that the software works in the way you need it to, cutting down months of focus-intensive work to just 10 days. Your validation documents will also be updated when a new version of the software is released, ensuring you are always compliant.

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General software validation

CompliancePath offer validation expertise on software applications that impact a life science organisation under regulatory control. This could be any system ranging from an ERP to a LIMS platform which will deliver real business outcomes for customers.

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Covid-19 life sciences hub

These resources focus on some of the key standards that life science organisations need to achieve in order to provide important services under the context of covid-19, including ISO 15189 and ISO 13485. 

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