Tech Solutions is a partnership that dedicates itself to provding robust technical solutions on an SME budget.
We have experience in developing applications within the pharmaceutical sector along with the validation work required to meet Annnex 11 and associated data integtiry requirements.
We have experience in creating, maintaining and monitoring quality systems. This covers the whole gamut of a quality manual from SOP maintenance through to CAPA and nonc conformance monitoring as well as auditing.
Managing Electronic Processes
We have experience in validating and controlling electronic processes in order to meet Annex 11 and data integrity requirements. This includes Risk assessment, URS, DQ, SAT / FAT, IQ, OQ, PQ.
Managing submissions via authority portals
Experience in managing the full workflow for portal submsission for license applications, license variations and product safety update reports.