Focused on High Value Cells

Service and support: Service Status Certification for laboratory accreditation

The quality of a cell line development (CLD) process is dependent on the optimization of many discrete, measurable stages. When considering the optimization of instruments used in CLD workflows, using technology that is fit for purpose, installed, maintained, operated and functioning correctly, and used by staff who are trained correctly, all contribute to a quality process.

Regular preventative maintenance and certification of instruments ensure the optimal performance of CLD instruments and provide added reassurance at the regulatory submission stages.

To protect your investment and ensure that our instruments continue to operate at peak performance, we offer comprehensive service and support packages, maximizing your investment and minimizing disruption. These include Installation Qualification (IQ), Operational Qualification (OQ), staff training and ongoing service packages which include preventative maintenance visits.

Installation Qualification (IQ) and Operational Qualification (OQ)

Solentim recommends the use of IQ and OQ protocols to evidence that the equipment being installed and used offers a high degree of quality assurance such that laboratory processes will consistently meet quality requirements and compliance.

Service Status Certification

Solentim’s ‘Service Status Certificate’ catalogues an individual instrument’s service record, highlighting continuation or deviation from best practice. This certificate can be used in the context of your laboratory accreditation.

Documenting IQ, OQ, regular servicing and preventative maintenance demonstrates a commitment to high-quality standards:

  • Our engineers provide service history certificates, detailing your instrument’s warranty, service plans and preventative maintenance schedules. These reports are valuable accompanying material when submitting clonality reports for confident regulatory submission.
  • A valid service plan with annual preventative maintenance certification provides evidence for laboratory accreditation.

To apply for your Service Status Certificate or to enquire about service operations, contact Chris Toy, Global Service Manager at [email protected].

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