Computer System
Validation Services

Validate your laboratory processes before CLIA and
ISO13485 certification.

Our client creates biotechnologies to research DNA. One of their inventions is a system for DNA sequencing, which is perfected a well put. According to MIT, the company holds third place in the list of 50 smartest companies of 2016 and it continues to develop.

computer system validation

Computer system quality, managed

Focus on the lab work you love and let us handle the rest

  • Accuracy and integrity of processed data

    Be always audit ready, fostering a culture of compliance across the organization.

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  • Simple validation of larger applications

    such as enterprise document management and lab information management systems.

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  • Shorten the validation cycle time by 60-90%

    and reduce the cost of your laboratory compliance​.

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End-to-end CSV solution

Right mix of a technology and professional services covers a broad range of control systems, laboratory instrumentation setups, and lab data capture systems (e.g. LIMS, ELN, SDMS, CDS, etc), manufacturing and clinical database systems, as well as interfaces with other GxP systems.

Validation planning

Producing a unique, personalized plan prepared by the laboratory and based on its IT landscape, data processing methods, and quality management techniques.

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Validation lifecycle services

Conducting a CSV while processes are in motion.
A complete set of test reports, the access of users who contribute data, quality and risk management procedures and much more.

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Validation testing and verification services

Installation, integration and functional testing of the IT landscape as a whole and any of its systems and system components, as well as many specialized automated tests such as «monitoring of sums and balances»

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Data integrity services

Checking that medical data is accurately and reliably processed, regardless of the format (paper or electronic), have unambiguous standards for storing and transforming, and have a defined policy for managing the risks of data corruption and integrity problems.

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Reporting & release

The Validation Report summarizes the activities carried out during the project, describes many deviations, with justification, from the Validation Plan, lists any limitations or restrictions on use, summarizes any incidents and details any outstanding and corrective actions.

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Got a project in mind?

There is no better place for a QA solution than Performance Lab.
Drop us a line to find out what our team can do for you.

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