Validations:

  • Computer Systems Validation (CSV)
  • Manufacturing Equipment Validation
  • Cleaning Equipment Validation

Validations includes:

The pharmaceutical business is regulated vigorously globally and is continually challenged by regularly advancing stringent directions, and the need to guarantee compliance. Genostats work closely to help our clients in the Pharmaceutical and life science industry prevail through recorded proof of the satisfaction of capability and validation protocols. Our main concern is helping our clients meet the exact standards of the DEA, EMA, and FDA.

Our validation specialists have a demonstrated procedure that incorporates documentation and auditing to give our clients a high-level of assurance that their procedure reliably creates results and items which accomplish the foreordained quality and specifications. Genostats Validation Solutions team strives every day to give predominant service and support in a steady, financially savvy way. Our continuous interests in training, research, and technology guarantee that our associates stay at the highest point of the business, and we remain unflinchingly dedicated to living up to our reputation for excellence. From little ventures to major, long haul remediation commitment, Genostats remains behind every last arrangement we deliver - and our extensive variety of specialties enable us to fill in as a end to-end regulatory consistence accomplice to our esteemed clients.

  •   Enterprise Resource Planning (ERP)
  •   Laboratory Information Management Systems (LIMS)
  •   Change Management Systems (CMS)
  •   Learning and Maintenance management systems
  •   Corrective and Preventive Actions (CAPA) and Complaint Management Systems
  •   Training tracking systems
  •   Deviation/issue/event-tracking systems
  •   Document management systems
  •   Manufacturing Execution Systems (MES)
  •   Programmable Logic Controllers (PLC)
  •   Supervisory Control and Data Acquisition Systems (SCADA)
  •   Validation Gap Analysis and Remediation
  •   Distributed Control Systems (DCS)

Manufacturing Equipment Validation:

  •   Laboratory testing equipment
  •   Aseptic/sterile handling
  •   API manufacturing
  •   Process chromatography gear
  •   Injection-molding equipment

Cleaning Equipment Validation:

  •   Filling and blending equipment
  •   Pumps
  •   Transfer systems
  •   Parts washers and autoclaves, CIP/SIP
  •   Weigh administer systems

Facilities and Utilities Validation:

  •   Utilities including HVAC, compacted air, water systems, and many others
  •   Equipment commissioning, qualification, and validation
  •   Modified IQ/OQ/PQ protocol advancement and execution
  •   Temperature and environmental mapping
  •   Execution of Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT)

Medical Writing

Our comprehensive records are peer reviewed and experience a stringent quality assurance to guarantee medical and scientific accuracy.

Regulatory Affairs

The pharmaceutical business is regulated vigorously globally and is continually challenged by regularly advancing stringent directions.

Pharmacovigilance / Drug Safety

In the present pharmaceutical, biopharmaceutical and medical device product scene, you can't bear to miss crucial safety data about your products.

CDISC Advantages

CDISC is the most significant advancement for convenience in data trade without perplexity inside the pharmaceutical business and between the industry and regulatory authorities.

Clinical Data Management

Clinical Data Management We comprehend that high-quality data is significant for the achievement or failure of the clinical trial. Genostats provides Clinical Data Management service.

CLINICAL STAFFING

In the clinical industry, it takes many years and an extraordinary investment to bring a product to license.

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