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Computer Systems IT Validation

OUR extensive experience and direct involvement in software development, project management, clinical data management, preclinical R&D, quality assurance and validation testing in the pharmaceutical and related industries has proven to be the key to our success in Computer Systems Validation Consulting.

 

We provide validfation consulting in Business, Technical as well as Regulatory environment.



  • 21 CFR Part 11 Assessments for IT Systems and understanding the regulatory requirements of 21 CFR part 11 and its implications on your organization

  • Auditing software vendors for compliance with 21 CFR Part 11

  • Developing IT training roadmaps to deal with the implications of Part 11

  • SOPs Preparation for IT Systems

  • Complying with electronic archiving requirements

  • Program Management for IT System implementation and IT System Validations

  • Navigating the audit trail

  • Project and Validation Documentation (VMP, IQ, OQ, PQ etc.

  • Professionals User Training for IT Systems and SOPs

A Practical and Proven Approach

Our proven expertise in the Computer systems IT validation industry allows us to :



  • Design practical validation strategies unique to the company and systems to be validated. We identify systems subject to regulatory requirements, evaluate associated risks, provide practical recommendations for managing the risks and identify the required activities to implement the recommendations.
  • Our experienced team can perform a review and evaluation of validation-related documentation to identify deficiencies and risks. We will identify gaps and/or other deficiencies and provide cost-effective recommendations to address these concerns
  • Our validation experts can review the system development methodology and evaluate its adequacy from the specific regulatory requirements and agency expectations standpoint and identify gaps in the existing documentation that provides the evidence that the respective system was developed, tested and deployed in a controlled manner.
  • Help our clients prepare for regulatory agency inspections by conducting mock FDA inspections of system development, validation and associated activities.
  • Develop custom SOPs specifically for the organization, process or system by conducting audit of the existing SOPs and establishing specific needs of our clients
  • Assist our clients by training their personnel in validation principles and techniques.
  • Performance of validation testing activities including developing a validation protocol, generating test data, performing actual "hands on" testing, documenting validation results and developing the validation summary report.
  • Provide a Risk Assessment for our clients by identifying existing compliance, strategic and operational risks for Management.
  • Assist management in evaluating and selecting software developed by a third-party software vendor by performing a vendor audit, develop a specific evaluation plan for internal personnel to execute, or advise internal personnel about specific validation-related issues.


In addition, we also provide

  • Total Quality Management Consulting that involves recommending and helping to implement a strategy of common methodologies, policies, standards, references, approaches, and procedures to be followed for a particular organization or system.
  • Qualification Consulting which involves assisting clients to qualify hardware, network and operating system platforms. The common activities include Installation Qualification - verifying that all key aspects of the hardware, network or operating system adhere to appropriate codes and approved design intentions - and Operational Qualification - documented verification that the system or subsystem performs as intended.

Our Clients either use our services for individual focus areas or to provide full life cycle solution implementation. We will be very pleased to discuss this approach in detail with your organization.

Some of our services we offer but not limited to are:


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