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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.

 
 
 
 
   Risk Based GxP Computer System Validation
 
Developing the Validation Rationale for various specific circumstances in alignment with Risk Based GxP Computer System Validation approach is really an art blended with scientific logic.  As the world is moving towards electronic, the Life Sciences Industry is not an exception to it. Life Sciences Industry is making use of multiple IT applications to efficiently manage their business functions across multiple functional areas such as Pre-Clinical, Clinical, Manufacturing, Sales and Marketing, Drug Safety and so on. It is very much required that the Individual organization should maintain all their IT applications in validated state across the System Development Life Cycle starting from Concept till Retirement.

 
   The following Key Questions from the Industry related to Computer System Validation:  
 
  • How could the Cost Effective Computer System Validation be performed?
  • How much Validation is required for the complex Computer System which is being used to
    capture the scientific data either in the Research and Development or in the Manufacturing business operations?
  • What does GAMP 5/ASTM E2500/FDA/EMA/Annex 11 recommend?
  • Systems which need not be validated?
  • How to Categorize GxP Critical and Non GxP Critical Systems and the respective Validation Approach?
  • How to perform Risk Assessment?
  • Can we leverage Vendor Documentation?
  • How to avoid Duplicate Validation efforts?
  • How to develop scalable Validation approach?
  • Is my Validation exercise sufficient?
 
 
SANHAR is a process driven organization and we do have excellent understanding of the Regulatory Expectations on Computer System Validation and we would be able to address all the above mentioned pain points. We also have expertise in defining the processes to address how the Validation fits into System Development Life Cycle. Our practical knowledge to exercise the validation activity as defined by multiple regulatory agencies/guidance such as USFDA, TGA, EMA, EU Annex 11, ASTM E 2500, and GAMP 5 is really one of our key differentiators.

 
   The following are some of our key differentiators to address an effective validation approach.  
 
  • Approach to address 21 CFR Part 11 (Electronic Records & Electronic Signature) requirements to fit into our Validation Process.

  • Approach to fit the Validation processes into the System Development Life Cycle.

  • Strategies for Science Based, Practical, Logical, yet Justifiable Computer System Validation.

  • Science based Risk Assessment to have the required level of validation across the Validation Life Cycle.

  • Approach to take advantage of New Recommendations from USFDA, EU Annex 11, ASTM E2500 and GAMP 5.

  • Scalable Validation Approach with appropriate Regulatory Applicability Assessment and Regulatory Compliance Assessment.

  • Effective usage of re-usable components to reduce the Validation Cycle time and Cost.

  • Usage of pre-defined, customizable templates for the deliverables such as Validation Master Plan, Risk Assessment, IQ,OQ,PQ Protocols and reports, Requirement Traceability Matrix, Anomaly reports, Regulatory Applicability Assessment & Regulatory Compliance Assessment Reports, Defect Log, Validation Summary Report and Release Memo.

  • Dynamic Validation processes as a part of Continual Improvement to accommodate required CAPA to our existing Validation processes as a result of the “Lessons Learnt” initiative through recent FDA Warning Letters/483s on Validation of Computer Systems.

 
 
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