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Regulatory Compliant Document Management &
eSubmissions Product Suite

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PharmaReady - Recent News - eCTD and eDMS solution

TAKE Solutions’ Life Sciences Division Announces Global Expansion of its Submissions Assurance™ Program (more)

TAKE Solutions’ Team Announces Conatus Pharmaceuticals the Winner in PharmaReady Best Case Study Contest (more)

New eCTD Submission Created Using PharmaReady 4.0 Passes FDA Validation (more)

Training Records Management System (TRMS)

PharmaReady TRMS is a web-based Training Record Management System specifically designed for Life Science organizations where ease of installation, ease of use, regulatory compliance, and affordability are the primary business drivers.

21 CRF Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals states that training in standard operations for each employee must be provided to ensure all employees are properly qualified to complete their assigned work tasks. The management of technical training and maintenance of a comprehensive and accurate file of training records for each employee is a daunting task. PharmaReady TRMS manages the entire process and gives you the tools to ensure your employees are adequately trained with the documentation you need to prove you are compliant.

PharmaReady TRMS is designed specifically for management of training related to SOPs, Work Instructions, and other Specifications documents within business areas regulated by the FDA. It can also be used for documenting any other employee training within your organization.

Key PharmaReady TRMS features include:

  • Email notifications to both Employees and Supervisors about any upcoming training that may be required.
  • Customizable, on-line assessments with results automatically reported to the Supervisor and stored in the Employee's training record.
  • Automatic notification of retraining when Specifications are updated.
  • e-Signatures for updating training records when needed.
  • Training management at the Employee, Supervisor, and/or Department level.
  • Executed Installation and Operational Qualification documents.
  • Administration Manuals.

Learn more about how PharmaReady TRMS can easily and seamlessly integrate with PharmaReady eCTD, SPL and DMS.

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