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   News & Events

28th Feb 2012: Sanhar is leveraged with Regional specific Regulatory Submission expertise and be able to help the customers in Multi Geographical Regulatory Submissions.

20th Feb 2012: Sanhar is an Associate Member of Indian Drug Manufacturers Association (IDMA), enabled with a gateway to reach out to more Domestic Customers now.

06th Jan 2012: Sanhar Joins hands with “Registrar Corp”, an U.S. based company to leverage its Regulatory Consulting services pertaining to the U.S. FDA Registration related Businesses.

 
 
 
 
   Software Quality Assurance
 

Software Quality Assurance is a broader term to address multiple compliance related activities within an organization such as Managing Compliance across System Development Life Cycle Processes, GxP Documentation and maintaining Validated State of all the IT systems throughout the entire System Development Life Cycle, starting from Concept till Retirement. The prime challenges to the Life Science industry is due to changes in the Regulations, Business Processes and sustaining the technological advancements from time to time. Meeting the regulatory requirements is a huge task indeed and highly critical to a pharmaceutical firm’s ability to operate. Keeping pace with industry standards and standardizing processes employed to meet the regulatory challenges for IT systems is an exhausting exercise that calls for a considerable amount of resources.

SANHAR Technologies understands the pressure facing compliance issues in today’s regulated environment, critical importance and underlying principles for the Software Quality Assurance activities of a Life Sciences Industry and develop a Cost-Effective, Risk Managed Software Quality Assurance strategy to address these issues. We have a team of Industry experts to help the Life Sciences Industry to meet the demands arising from the challenges faced. Understanding the industry, helping the clients achieve regulatory compliance, helping customers to invest in changes and upgrades has been the core function of SANHAR Technologies’ compliance services. In this Software Quality Assurance space, our services include but not limited to

 
  The following Key Questions from the Industry related to Computer System Validation:  
 


  Managing System Development Life Cycle Processes

  • Managing Compliance across SDLC phases such as Concept, Design, Implementation, Operation and Retirement.
  • Change Management
  • Release Management
  • Configuration Management
  • Compliance related Cross Functional Activities
  • Compliance Workflow Management

  GxP Documentation

  • Authoring Policies, Standard Operating Procedures and GxP documents
  • Managing
  • Validation documents
  • Change Control Records
  • Training Records
  • Critical Process Control Records
  • Audit Reports
  • Audit findings/Non-conformance Reports
  • Audit Remediation Reports
  • CAPA records and related documents

  Maintaining Validated State of the IT Systems throughout the entire SDLC

  Performing appropriate Validation exercise for the

  • Commercially Off the Shelf (COTS) applications
  • Homegrown/Custom Built applications
  • Enhancement of the Existing applications

 
 
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