Enter the basic details for your system. This information will be used to generate the risk assessment, phases, tasks, and compliance requirements.
System Name: A clear, descriptive name for your system.
System Type: Select the type of system (e.g., LIMS, SAP, UiPath, etc.).
GAMP 5 Category: Hardware/software category per GAMP 5 guidelines.
Deployment Model: How the system is deployed (on-premise, cloud, etc.).
Tip: Fill all required fields. Use accurate information for reliable risk assessment.

Define the technical characteristics of your system. This will be used to assess technical risks and validation requirements.
System Complexity: Overall complexity of the system architecture.
Integrations: Number of external system integrations.
Data Volume: Expected data processing volume.
System Maturity: Development stage and stability.
Vendor Support: Quality of vendor technical support.
Tip: Be realistic about complexity - overestimating can lead to unnecessary validation effort.

Define the regulatory and compliance requirements for your system. This determines the validation scope and documentation requirements.
GxP Data: Does the system handle regulated data?
Regulatory Scope: Which regulatory bodies apply?
Electronic Signatures: Required for 21 CFR Part 11 compliance.
Audit Trail: Data change tracking requirements.
Data Integrity: ALCOA+ compliance level.
Patient Safety: Impact on patient safety if system fails.
Tip: Consult with regulatory affairs for accurate compliance requirements.

Define operational characteristics that affect risk and validation scope.
Business Impact: Consequences if system fails.
Number of Users: System user base size.
Geographic Distribution: User locations.
Change Frequency: How often the system changes.
Historical Issues: Past performance and incidents.
Tip: Consider worst-case scenarios for business impact assessment.