Overview

In the process of being compliant, organizations require agility and accuracy. To be on par with ever-evolving compliance requirements in a time-critical manner, to make the processes easy for effective transformation, and to gain confidence with the auditors, it is required for organizations to streamline the processes while reducing data/document manipulation by taking the route of automation. To do so, the best they can do is to implement tailor-made software/systems.

As one of the top notch Regulatory software solutions provider, Freyr assists organizations to automate the end-to-end processes right from SOP writing to documentation to compliance. Freyr is capable of integrating CAPA, QMS, HR, Helpdesk ticketing automation systems. Freyr caters automated systems with a GxP workflow with effective monitoring enabled with electronic signatures. The GxP software solution consulting provided by Freyr can be broadly segmented into the following systems:

 

Freyr Expertise

CAPA Systems

Whenever there is a challenging situation like complaints/non-conformance, it demands organizations to take the Corrective and Preventive Action (CAPA) route. Following the effective route-cause analysis, companies might have to implement the corrective or preventive actions to rectify the errors in current project or to eliminate them for upcoming ones. Tracking the entire process will be challenging for organizations, if the documentation is not automated.

With a tailor-made CAPA system enabled with GxP workflow, Freyr supports organizations’ need to be agile and automated while being compliant.

  • Route-cause analysis for errors
  • Corrective Action
  • Preventive Action
  • In-detail documentation
  • Document Automation

QMS Systems

In general, Quality Management System (QMS) is meant for writing/reviewing/rolling out new SOPs. As the process leads to many versions of documents, organizations might have to deal with huge pile up of paper work, if the system is not automated. Not only that, Regulators or auditors may question the accuracy of document generation dates. They may rise concerns about the document being backdated.

To make sure companies avoid such accuracy related queries throughout the lifecycle, Freyr offers fully automated QMS system with a GxP workflow that supports electronic signatures and audit trails.

  • SOP automation
  • Accurate Documentation
  • GxP workflow enabled
  • No manual-driven signatures

HR & Training Automation Systems

As an integral part of GxP and the enterprise, training goes through multiple iterations whenever there is a SOP change, new SOP introduced or any other new process transformations. Automating the entire training process may not only suffice the Regulatory requirements, but also helps organizations from business perspective in terms of saving lot of paper and administrative processes. Right from training need analysis to conduct of the training, organizations face difficulty in managing the documentation if not automated.

With an integrated GxP workflow, Freyr offers HR & Training Automated systems to ensure the training processes are streamlined and better recorded for future references/amendments.

  • Training Automation
  • Accurate Documentation
  • GxP workflow Integrated

Service / Helpdesk Ticketing Systems

Adapting to the market requirements, in today’s business scenario, organizations inclined towards offering software as a service. While doing so, there are many procedural challenges while sharing/requesting the confidential data with/from clients. To make sure the processes are secured, the best approach is to integrate automated service/helpdesk ticketing systems.

Freyr adhering to GxP workflows offer software as a service to customer, to enable them share/access the confidential data through password protected environment. Offering as a stand-alone solution, Freyr’s Service/Helpdesk ticketing system ensure the client data is better transitioned and protected.

  • SAS Offering
  • Service/helpdesk ticketing automation
  • GxP workflow integrated

Freyr Advantages

  • Ensuring product quality, Regulatory compliance, patient safety, data integrity and security
  • Experienced and practicing professionals
  • Proven consultation for software compliance
  • Integrated process models
  • Effective and compliant business processes
  • Proven validation and qualification strategies
  • Quick turnaround timeframes
  • Significant cost savings