The Quality Systems Team at the Genome Sciences Centre works with the production laboratory groups to ensure quality service is provided to our internal and external clients. The QA group was initially established within the Sequencing group and now provides service to all production laboratory platforms including Illumina and Capillary Production sequencing, Functional Genomics Library Core, Functional Genomics Technology Development, Mapping and Vectorology.
Coordinated the CAP accreditation project, which was initiated in 2011 for the GSC’s clinical pipeline involving ABI capillary sequencing instruments for testing BRCA1/BRCA2 breast cancer genes. Later in 2013, the clinical pipeline expanded to 16 gene panel testing with Illumina Sequencers, and now the GSC provides targeted capture panel testing for three cancer panels: hereditary cancer panel, onco panel and myeloid panel.
Working with various collaborators from Ottawa Hospital Research Institute and the Biotherapheutics Manufacturing Centre, coordinated activities for preparing the quality overview summary (QOS) of the clinical trial application, addressing all requirements set forth by Health Canada’s guidelines: For Clinical Trial Sponsors- Clinical Trial Applications and guidelines for Preparation of the Quality Information for Drug Submissions in the CTD Format- Biotechnological/ Biological (Biotech) Products.
Coordinated the ISO 27001 certification project by collaboratively working with various internal GSC staff and external certification body to implement ISMS systems, processes and policies in order to meet requirements prescribed under six main clauses and Annex A with 13 control objectives of the standard. The GSC was ISO certified in December 2018 with zero deficiencies.