Design Control

Simploud's Design Control module offers a collaborative and compliant approach to managing the entire design process for life sciences organizations. Built around Simploud's innovative electronic binder concept, it is purpose-built to handle design input, design output, design review, design verification and validation, and design changes within a single, structured environment.

The electronic binder in Simploud provides a revolutionized way to control complex processes, making it equally suitable for design control and other intricate projects such as complicated change controls. As a native Simploud record, the binder supports all core platform features including workflows, tasks, forms, automations, and related items, while also introducing advanced capabilities unique to managing complex, multi-layered structures.

Folder Hierarchy and Structure Management

• Users can create multiple folder structures with unlimited depth, enabling the creation of as many design templates as needed.
• Each folder can contain one or more items, all of which are searchable and automatically updated.
• The top level of the binder provides an overall structure encompassing all managed data for a specific design version, including design documents, electronic requirements and their associated tests, risks, and an overall traceability matrix.

Full Audit Trail

• Every change made to any item within the binder is automatically reflected in the binder's audit trail.
• Users can quickly identify what has changed recently, regardless of which binder record was modified.
• Auto Update Version functionality ensures that whenever an item in the binder is revised and the new revision becomes effective, it automatically replaces the obsolete revision across all binders in which it is included.
• If a binder is in a frozen status, the auto update is halted, preserving the binder's condition as it was at the time it was frozen.

Dynamic Risk Matrix

• Every risk added to the binder is automatically evaluated against the binder's risk matrix.
• Each binder can have its own customizable risk color scheme, which can be updated by an authorized user as needed.

Electronic Verification and Validation (V&V)

• Requirements and tests can be added electronically to the binder, enabling tests to be executed directly within the system.
• Users can execute any combination of tests directly from the binder interface, streamlining the V&V process.

Live Traceability Matrix

• The electronic binder includes a live traceability matrix that displays all of the binder's requirements alongside everything linked to them.
• Tests, risks, and any other items included in the binder can be linked to any requirement, providing a single unified view of all requirements and their current status.

Simploud's Design Control solution is designed to be secure, scalable, and compliant, serving a broad range of life sciences industries including medical devices, biotechnology, pharmaceuticals, digital health, and more. The platform's integrable architecture ensures it can fit into existing organizational ecosystems while maintaining the compliance standards required in regulated industries.