Challenge:

Registration of Deviations and monitoring of associated CAPAs

Resolution:

The Rescop RC-Deviation solution

Key Features of the Rescop RC-Deviation Solution:

  • Fully electronic Deviation and CAPA lifecycle management including creation and approval of all required documentation
  • Root Cause Analysis and Risk Assessment of Deviations and CAPAs
  • Create, assign and monitor CAPAs
  • Email alerts ensure activities are completed on time and escalation email alerts provide you with immediate visibility of any overdue tasks
  • Management and Key Performance Indicator reporting
  • Qualified and GxP compliant COTS solution to ensure a rapid implementation cycle
  • 21CFR Part 11 compliant e-signature capabilities

Deviation and CAPA Management System (RC-Deviation)

“To err is human”
An Essay on Criticism” by Alexander Pope 18th Century English poet

Alexander Pope was a very famous poet, but he could have been speaking as a Quality Professional, tasked with dealing with Deviations and deciding what kind of Corrective or Preventive action needed to be undertaken, when he coined the phrase above.

Deviations from Process, Accidents, Customer Complaints and more need to be recorded, assessed, analyzed and actions determined to remedy them, and more importantly, determine ways of preventing their re-occurrence. The vast majority of organizations today manage this with a series of documents, spreadsheets and manual reports, often failing to spot trends, common root causes, or ensuring that they check the effectiveness of any action taken.
Actions themselves pose new challenges in ensuring they are approved, executed at the right time by the right resource, and ensuring that their effectiveness is confirmed with a follow up check. All of this work is typically done with a combination of tools, and usually in a very manual fashion, increasing workload and reducing efficiency.

There just must be a better way! There is; RC-Deviation from Rescop.

RC-Deviation provides a centralized repository for all Deviations and CAPAs and ensures a consistent process thanks to the standardization of approach, documentation and content. The Deviation an CAPA Management solution enables you to discover the Root Cause and identify risks to ensure a reduction in issue recurrence, all leading to greater customer satisfaction. Automated workflows enable you to facilitate compliance and increase efficiency and accuracy all in a paperless environment.

The Rescop RC-Deviation solution covers the entire deviation lifecycle and is provided using proven technology which is available, rapidly deployed and available via a secure and validated cloud solution.

Request a free demo: