Challenge:

Validation project Delivery; Efficiently, on budget and without large volumes of paper.

Resolution:

The Rescop RC-VLM solution

Key Features of the Rescop RC-VLM Solution:

  • Provides consistency with the appropriate documentation for each GAMP Level
  • Automatically generates the Traceability Matrix to ensure full requirement coverage
  • Design assistance to enable the use standard requirements and test cases
  • Leverage previous Qualification Documentation to ensure best practice and avoid starting from a blank page every time
  • Real-time reporting of ongoing qualification activities
  • A complete history of all Validation Activities coupled with management reporting
  • A powerful workflow engine that supports the preparation of required documentation, from draft, review and through to approval
  • Email alerts ensure activities are completed on time and escalation email alerts provide you with immediate visibility of any overdue tasks.
  • Fully qualified and GxP compliant COTS solution to ensure a rapid implementation cycle
  • 21CFR Part 11 e-signature compliant

Validation Lifecycle Management System (RC-VLM)

You are a hard-working Validation Manager, responsible for the validation of several mission critical systems. You need to ensure that the work is done correctly, that all the i’s are dotted, and t’s are crossed, and that all of the requirements are properly tested. You have gigabytes of files, Word files, PDFs, Excel files to manage, and nearly every day another review or approval task is due, overdue, or worse still, vanished!

You rely on your companies’ email solution to route documents for review and approval, but you find yourself spending more and more time chasing reviewers and reviewers to complete their tasks. For their part, your reviewers and approvers are also struggling to keep up with what version of what document needs to go to what author. Frustration, delays and woeful inefficiency have become the new standard and seems it will be for all of time.

The good news is that the end is nigh! The end to email-based document review and wrestling with an ever growing and complicated Traceability Matrix. The key to streamlining you processes and making huge efficiency gains is RC-VLM from Rescop.

The Rescop RC-VLM solution provides the tools required to perform system validation of systems in an efficient, controlled and reproducible manner. The solution efficiently manages all types of validation activities, including, equipment, instruments, computer systems, manufacturing lines, and process validation. RC-VLM covers the entire validation lifecycle and is provided using proven technology which is available, rapidly deployed and available via a secure and validated cloud solution.

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