We accompany and support our clients throughout the entire process of installation, commissioning, qualification, and validation of our systems, guiding them through the various phases of Computerized System Validation (CSV).
We coordinate technical activities, prepare specifications and validation protocols for FAT, SAT, IQ, and OQ, and develop documentation tailored to the client’s requirements and specific needs.
Installation and Validation
We support our customers at every stage: from installation and commissioning to the qualification of plants, machines, and systems.
We begin by analyzing the User Requirements Specification (URS), develop the functional specifications (FS), hardware specifications (HDS), and software specifications (SDS), and prepare the documentation package.
We define the protocols and perform Factory Acceptance Tests (FAT) and Site Acceptance Tests ( SAT), supporting the subsequent Installation Qualification (IQ), Operational Qualification (OQ), and, where applicable, Performance Qualification (PQ).
Upon request, we customize validation protocols based on the machine’s configuration and the client’s User Requirements Specification (URS).
Our risk-based approach aligns with GAMP 5 guidelines and the applicable requirements of GMP Annex 11 and Annex 15, and includes verification of equipment, hardware functionality, automation systems, and software functionality.
For computerized systems, documentation and verification are defined based on criticality and intended use and may include software functionality, access controls, data flows and integrity, alarms, backups, and recovery.
The result is a structured and traceable process, from the initial requirements to the final documentation package.
Installation and Validation
Relying on a structured service for installation, validation, and documentation simplifies system management, optimizes internal resources , and allows you to approach each audit with greater confidence.
Practical support that offers numerous benefits.
Documentation that has already been prepared, organized, and is easy to find.
Less staff involvement in verification and preparation activities.
Comprehensive and up-to-date evidence, available when needed.
Fewer errors, omissions, and nonconformities.
All processes, checks, and actions are always documented.
Validation and documentation become an integral part of its value.
Installation and Validation
Drafting and reviewing technical documentation related to the device's operation, design decisions, the configuration implemented, and the processes put in place.
User Requirements and URS
Hardware Specifications (HDS)
Software Specifications (SDS)
Risk Analysis
Configuration Description
Drawings and Schematics
Parts Lists
User and Maintenance Manuals
Material and Calibration Certificates
Technical documentation supporting applicable GMP requirements
Collection and organization of documentation related to third-party components integrated into the systems:
Manuals and technical data sheets
Certificates
Declarations
Installation and maintenance instructions
Hardware and Software Specifications
Protocols and supplier test reports
Preparation of FAT, SAT, IQ, and OQ protocols, with the option to customize content, tests, and acceptance criteria based on:
Machine characteristics
URS and approved specifications
Risk analysis
Customer’s internal procedures
Applicable GMP Requirements
Agreed Acceptance Criteria
Execution and reporting on the validation and qualification protocols agreed upon with the client.
FAT — Factory Acceptance Test
SAT — Site Acceptance Test
IQ — Installation Qualification
OQ — Operational Qualification
Installation and Validation
In connection with the installation of new equipment that requires validation and certified qualification before it becomes fully operational.
When updates to PLCs, HMIs, supervisory systems, or applications can alter functionality, parameters, access rights, data flows, or interfaces.
In the event of a hardware retrofit, replacement of critical components, or modifications that may affect the configuration or qualified status.
In preparation for or following audits and inspections, it may be necessary to update and supplement the technical documentation.
Contact us to find out how our after-sales services can improve the efficiency of your systems.
We’re here to help with any of your needs.
