Requirement: Each user must have a unique ID and password. Shared or generic accounts are prohibited for users who perform GxP-relevant actions.

Implementation Steps:

• Integrate with a central identity provider (e.g., Active Directory, Okta).
• Establish a formal process for provisioning, modifying, and de-provisioning user accounts.
• Ensure user IDs are not reassigned.
• Link user ID to a real, verified identity.

Requirement: The principle of least privilege must be applied. Users should only have the minimum level of access required to perform their job functions.

Implementation Steps:

• Define user roles based on job functions (e.g., Lab Analyst, QA Reviewer, System Admin).
• Document permissions for each role.
• Map users to one or more predefined roles.
• Conduct periodic access reviews (e.g., quarterly, annually) to ensure roles and permissions remain appropriate.
• Ensure administrative roles are tightly controlled and monitored.

Requirement: Enforce strong authentication controls to prevent unauthorized access.

Implementation Steps:

• Password Complexity: Minimum length, mix of character types.
• Password History: Prevent reuse of recent passwords.
• Password Expiration: Force periodic password changes (e.g., every 90 days).
• Account Lockout: Lock accounts after a set number of failed login attempts.
• Session Timeout: Automatically log users out after a period of inactivity.
• Multi-Factor Authentication (MFA): Strongly recommended for all users, especially those with administrative privileges.

Requirement: Secure, computer-generated, time-stamped audit trails must independently record user access and actions.

Implementation Steps:

• Log all login attempts (successful and failed).
• Log all changes to user permissions and roles.
• Ensure audit trails cannot be modified or deleted by users.
• Implement a process for regular review of access logs for suspicious activity.

Requirement: A documented procedure for backing up all GxP-relevant data, including metadata and audit trails.

Implementation Steps:

• 3-2-1 Rule: Maintain at least 3 copies of your data, on 2 different media types, with 1 copy off-site.
• Backup Frequency: Define based on data criticality and rate of change (e.g., daily incremental, weekly full).
• Scope: Ensure backups include application data, configurations, operating systems, and audit trails.
• Automation: Automate backup jobs to ensure consistency and reliability. Monitor for success/failure.

Requirement: You must prove that you can reliably restore data from your backups. An untested backup is not a backup.

Implementation Steps:

• Periodic Restore Tests: Schedule and perform regular tests (e.g., quarterly) to restore a system or dataset to a sandbox environment.
• Data Verification: After restoration, verify the integrity and accuracy of the restored data. Check timestamps, content, and audit trail records.
• Documentation: Document the results of every restore test, including any issues found and corrective actions taken.

Requirement: Backups must be stored securely to prevent tampering, degradation, or unauthorized access, and retained for the required period.

Implementation Steps:

• Physical Security: Secure storage for on-site media (e.g., locked, fire-resistant safe).
• Encryption: Encrypt backup data both in transit and at rest.
• Access Control: Strictly limit access to backup media and systems.
• Off-site Storage: Use a secure, environmentally controlled off-site location or a validated cloud storage provider.
• Retention Policy: Align backup retention with your organization's record retention policies for GxP data.

Requirement: Understand the impact of downtime for each GxP system to prioritize recovery efforts.

Implementation Steps:

• BIA: Analyze business processes and the systems that support them to determine the financial and operational impact of an outage.
• Recovery Time Objective (RTO): Define the maximum acceptable time a system can be down after a disaster.
• Recovery Point Objective (RPO): Define the maximum acceptable amount of data loss, measured in time (e.g., 1 hour, 24 hours).
• RTO and RPO values will drive the selection of your DR technology and procedures.

Requirement: A formal, written plan that details the step-by-step procedures to recover systems at an alternate site.

Implementation Steps:

• DR Team: Define roles, responsibilities, and contact information.
• Activation Criteria: Clearly define what constitutes a disaster and who can declare it.
• Recovery Procedures: Detailed technical procedures for failing over systems to the DR site.
• Communication Plan: How to communicate with stakeholders during a disaster.
• Failback Procedures: How to return operations to the primary site once it's restored.

Requirement: Maintain a DR capability and test it regularly to ensure it works as expected.

Implementation Steps:

• DR Site: Establish an alternate processing site (e.g., a secondary data center, a validated cloud environment) geographically separate from the primary site.
• Data Replication: Use technology (e.g., asynchronous replication) to keep data at the DR site up-to-date, in line with your RPO.
• Tabletop Exercises: Walk through the DRP with the team to identify gaps.
• Failover Testing: Perform at least annual tests where you actually fail over production systems to the DR site to validate RTO and the plan's effectiveness.

Requirement: Implement layered security controls to prevent malware from entering and spreading across the network.

Implementation Steps:

• Endpoint Security (EDR/XDR): Deploy advanced anti-malware solutions on all servers and workstations.
• Email Security: Use advanced filters to block malicious attachments and links.
• Network Segmentation: Isolate critical GxP systems in a secured network zone to limit the blast radius of an attack.
• Vulnerability Management: Regularly scan for and patch vulnerabilities in operating systems and applications.
• User Training: Conduct regular security awareness and phishing simulation training.

Requirement: Be able to quickly detect and respond to a security incident to minimize its impact.

Implementation Steps:

• Security Monitoring (SIEM): Centralize and monitor logs from critical systems, firewalls, and security tools.
• Incident Response Plan (IRP): Develop a formal plan that defines steps for containment, eradication, and recovery.
• IR Team: Designate an incident response team with clear roles.
• Playbooks: Create specific playbooks for common scenarios like a ransomware outbreak.

Requirement: Your recovery strategy must account for ransomware, which actively targets backups.

Implementation Steps:

• Immutable Backups: Use backup solutions that store data in a non-erasable, non-rewritable format for a set period. This is your most critical defense.
• Air-Gapped Backups: Maintain a copy of backups that is physically disconnected from the network.
• Clean Recovery Environment: Have a plan to restore data to a clean, isolated "recovery sandbox" to ensure you are not re-introducing malware into your production environment.
• Test Recovery from Immutable Store: Regularly test your ability to restore from your secure, immutable backups.