Frequently Asked Questions

Ankush - Raksha is a centralized control and compliance management software designed for GxP-regulated industries such as Pharmaceuticals, Biotech, Food, Medical Devices, and Laboratories.
It helps organizations ensure data integrity, access control, and audit readiness in alignment with global standards like 21 CFR Part 11, GMP, and Annex 11.
Ankush - Raksha enforces controlled access, role-based permissions, and secure audit trails across all connected computers.
Every change — such as profile updates, feature restrictions, or user actions — is logged automatically, ensuring complete traceability and compliance with data integrity principles (ALCOA+).
No.
Ankush - Raksha is designed to eliminate the need for remote access tools.
Admins can activate/deactivate profiles, change settings, or restrict features directly from the server without taking remote control of any client computer.
This ensures better data security and faster control.
Yes.
Ankush - Raksha can be configured to work alongside your existing IT infrastructure, servers, and validation environments.
It supports both stand-alone and network-based deployments, depending on your system architecture.
Ankush - Raksha maintains comprehensive audit and activity logs, including:
• Profile changes made by admin
• Profile activation/deactivation events
• Attempted access of restricted features by users
• Configuration or permission modifications
All logs are tamper-proof and stored in compliance with audit requirements.
Yes.
Admins can create and assign multiple profiles with specific access rights, restrictions, or permissions.
Profiles can be activated, deactivated, or switched remotely for any client system — all from a centralized server.
Ankush - Raksha automatically tracks every user activity, configuration change, and system event.
This ensures data is attributable, legible, contemporaneous, original, and accurate (ALCOA+ principles) — providing strong evidence of compliance during audits or inspections.
No.
While Ankush - Raksha is widely used in pharmaceutical and biotech sectors, it is equally beneficial for any GxP-regulated industry, including:
• Food & Beverages
• Cosmetics & Personal Care
• Medical Devices
• Chemical & API Manufacturing
• Clinical Research Organizations (CROs)
• Life Sciences Laboratories
• Animal Health / Veterinary
• Blood Banks / Biobanking
• Healthcare Distribution & Supply Chain
Yes.
Ankush - Raksha has been designed keeping 21 CFR Part 11, Annex 11, and GMP requirements in mind.
It supports controlled access, electronic records management, audit trails, and system validation — all essential for compliance.
During audits, Ankush - Raksha provides complete activity reports, profile change histories, and user logs, demonstrating full compliance and control.
This reduces audit preparation time and ensures data integrity evidence is readily available.
Yes.
Ankush - Raksha can be configured or customized according to your organization’s workflow, department hierarchy, and IT policy requirements while still maintaining GxP compliance.
Ankush - Raksha supports Windows-based environments and can be deployed on both physical and virtual servers.
Detailed system requirements depend on the number of client systems and data volume, which our technical team can help assess.
No.
Ankush - Raksha is designed for secure on-premise deployment, ensuring your sensitive production or QA environment remains isolated and protected.
However, optional secure remote access modules can be configured if needed.
Ankush - Raksha offers flexible licensing based on number of client systems or users.
We provide complete installation, validation, and ongoing technical support, including remote assistance, software updates, and GxP validation documentation.
Unlike traditional IT control tools, Ankush - Raksha is built specifically for GxP-regulated environments.
It combines IT system control with regulatory compliance features — centralized management, user activity logs, audit readiness, and data integrity — all in one system.