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Computer System Validation in Life Sciences

The Life Sciences industry is witnessing a growing surge in numerous pharmaceutical regulations over the changing technology landscape. This poses challenges and also brings opportunities in the form of innovating new procedures, ensuring internal procedural harmonization, and building varied expert implementations in validation practices for computer systems.

Lack of standardization, and inconsistent interpretation across policies, procedures and different templates, force organizations to incur significant costs. Paper-based execution of validation creates inconsistent documentation, review & approval delays, ineffective tracking, and time-consuming audits. This creates an imbalance in monitoring, and ensuring adequate utilization of global systems, thereby negatively impacting the ROI.

LTI’s Computer System Validation in Life Sciences is a unique solution, empowering organizations to simplify their validation woes. LTI’s CSV for Life Sciences consists of an automated validation strategy incorporating coaching, planning and implementation, through agile methodology that generates greater value for pharmaceutical clients. We initiate risk evaluation, and assess system quality, accuracy, reliability and performance at different stages of the validation process.

Highlights

  • Creation of a validation strategy, validation plan, the required lifecycle documents, and a validation report.
  • Validation and review of IT systems for GxP, 21 CFR, and other compliance standards.
  • Realization of more value through automation, by ensuring on- demand, pan enterprise availability of the regulatory audit documentation approach.
  • Company-wide policies for computer validation, including operating procedures (SOPs).
  • Risk management and checklist-based risk analysis.
  • Implementation of requirement management, and moderation of workshops.
  • Support and implementation of change management & deviation, incident and CAPA management.

Benefits

  • Improved compliance by 75%, with reduction in manual errors.
  • Enhanced risk management, by identification and analysis of risks pertaining to regulatory, business function, and application requirements.
  • Reduced GTM time by 25%.
  • Reduced validation lifecycle time by 30-50%.
  • Improved visibility through enhanced auditing, and achieving greater ROI.

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