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ValSyner CSV team validates GxP, SOX, Data Privacy relevance IT applications & qualifies the related infrastructure/cloud as per 21 CFR part 11, EU Annex 11, and GAMP 5 guidelines. Establishing QMS to support the validation framework. Providing training and audit services to life science organizations. Also, conduct the CSV projects audits, generate the report and ensure compliance status.
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GxP Equipment Qualification & Process Validation
ValSyner GxP team is providing equipment qualification and GxP processes (Autoclave, Cold chain, HVAC) validation services to Laboratories, Clinical Research, Manufacturing & Medical devices sites to comply with 21 CFR Part 11, 58, 210,211,820, EU GMP regulations, etc.
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Audit – CSV, Research, Clinical & Manufacturing
Valsyner conducting the various types of audit including CSV, GLP, GCP, & GMP for life sciences also conducting the SOX and ISO 13485. We have a team of auditors having more than 20 + yrs. exp. in life sciences and CSV projects implementation and auditing mgmt. from a compliance perspective.
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