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 Standard Operating Procedure (SOP) writing to documentation to compliance. Freyr is capable of integrating Corrective and Preventive Action (CAPA), Quality Management System (QMS), Human Resource (HR), Helpdesk ticketing automation systems. Freyr caters automated systems with a GxP workflow with effective monitoring enabled with electronic signatures.

 

Freyr Expertise

CAPA Systems

Whenever there is a challenging situation like complaints/non-conformance, it demands organizations to take the 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.

  • Root-cause analysis for errors
  • Corrective action
  • Preventive action
  • In-detail documentation
  • Document automation

QMS Systems

In general, 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 enablement
  • 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 integration

Service / Helpdesk Ticketing Systems

Adapting to the market requirements, in today’s business scenario, organizations are inclined towards offering software as a service (SaaS). 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 SaaS 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 ensures the client data is better transitioned and protected.

  • SaaS offering
  • Service/helpdesk ticketing automation
  • GxP workflow integration

Freyr Advantages

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