Validation Approach

Life science companies must manage global compliance standards and accelerating performance expectations to maintain a competitive advantage in the industry. Companies are looking to decrease costs, accelerate time to market, increase productivity, while achieving, simplifying and maintaining compliance. 

inPursuit Technologies provides a comprehensive enterprise solution to support US regulatory requirements for regulated applications (see list below). 

inPursuit’s Validation Approach Packages are a complete set of validation document templates for each based on common, general requirements for life science companies and contain the following compliance documentation:

  • Computer System Validation Plan

  • Risk Assessment

  • Business Requirements Model

  • System Requirements Specification

  • Installation Qualification

  • Operational Qualification

  • Performance Qualification

  • Traceability Matrix

  • Standard Operating Procedure Checklist

  • Validation Summary Report

inPursuit’s Validation Approach Packages can decrease both validation time and validation costs by 50%, as well as provide for faster implementation time and better system performance. Our Validation Professionals provide an industry proven best practice approach to validation and compliance.

The more complicated State and Federal regulations become, the more challenging it becomes for organizations in the Life Science and other regulated industries to utilize computer systems in a fully compliant manner. These organizations have to plan, implement and document all validation activities not just from the standpoint of meeting critical compliance requirements but also to enhance security, reliability, safety, efficiency and profitability. 

This situation creates several challenges such as:

  • Identifying people with the right skill and experience and the related resources to stay up-to-date with rapidly changing regulatory developments and to be constantly prepared for an FDA audit/inspection.

  • Recruitment, training, development and deployment of in-house personnel to meet regulatory compliance requirements are always a costly proposition.

  • Meeting consumer demand for high quality standards at affordable prices under difficult economic environment.

  • Balancing dual priorities of equal importance: the ongoing regulatory changes in the industry as well as the implementation of new processes and technologies.

Why inPursuit?

  • Direct access to subject matter experts who have deep and relevant experience and current knowledge across a broad spectrum of validation and compliance practices

  • Predictable costs through the implementation of clear roles and competence frameworks

  • Elimination of validation bottlenecks, by taking it off the critical path of your projects, leading to faster project completion

  • Access to independent auditing by a group of highly skilled compliance professionals.

  • Ongoing collaborative review of validation procedures, securing timely opportunities to implement a risk-based validation methodology.