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Discover all our services

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.

1

Computer System Validation (CSV/CSA)

ValSyner CSV team validates GxP, SOX, and 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.

2

Software Development and Testing Services

ValSyner supports entire GxP testing activities complying with current regulations and industry standards. Testers are qualified and well-trained in Good Testing & documentation practices.

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3

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.

4

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.

5

Training Services

ValSyner conducts training on various topics of Computer System Validation, GLP, GCP, and GMP for life sciences companies.

 A team of ValSyner trainers are working in life sciences for the last 20+yrs, they are qualified to conduct training sessions.

6

Project Management

ValSyner project management team is managing the CSV projects starting from the initiation phase till Go live & operational run phase. We highly recommend our clients to avail our Project management services.

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Our Clients

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