BUILT IN BARCELONA
Ready to produce.
Ready to audit.
The more technical information you share, the more specific our first response can be.
01
Design for compliance
Regulatory requirements translate into design, automation, materials, and documentation decisions from the start
02
Risk-based approach
Risk analysis guides controls, testing, and evidence, avoiding generic documentation that has no connection to the process.
03
Traceability
We link requirements, specifications, risks, and tests so that each criterion has verifiable evidence.
04
Data integrity
When the scope requires it, we include users, roles, audit trails, electronic records, and backup strategies.
APPLICABLE FRAMEWORKS
The right scope for each project.
RIJAT designs according to the applicable requirements agreed with the client. The inclusion of each frame depends on the product, intended use, control architecture, and country of installation.
CE
Safety, risk assessment, and technical file
EU GMP
Annex 1 and Annex 11 when they are applicable
GAMP 5
Lifecycle and risk-based approach
21 CFR
Part 11-ready controls according to functional scope
APPLICABLE FRAMEWORKS
Documentation that connects requirements and evidence.
RIJAT designs according to the applicable requirements agreed with the client. The inclusion of each frame depends on the product, intended use, control architecture, and country of installation.
01 Project Quality Plan
02 URS review & traceability matrix
03 Functional / hardware / software specifications
04 Design risk assessment
05 Material certificates and component traceability
06 FAT / SAT protocols and reports
07 Material certificates and component traceability
08 Manuals, drawings, backups and as-built package
Accuracy in statements.
START A PROJECT
¿Do you have a URS or a process to sort out?
Share the product, packaging, cadence, and target market. Our technical team will structure the next step.
