Neyret Group Validation and Qualification services

As part of its mission to develop fully customized turnkey solutions for any area of application, regardless of sector or geography,  the Neyret Group offers a comprehensive set of validation and qualification services for its indexed motion and continuous motion assembly systems.

These allow clients fast-track assurance that their systems comply with all standards demanded by international regulators.

QA control and requirements

Both arms of the Neyret Group, Societe Guy Neyret (SGN) offering indexed motion systems and Lagniel for continuous motion solutions, share the same quality assurance (QA) organisation that is responsible for two key aspects:

• control and oversight of the design, manufacture and checking processes
• responding to the requirements of the pharmaceutical, medical or automotive sector.

For all Neyret Group customers, this means access to a Quality Department that will liaise with clients at every stage, from initial design phase right through to final product approval.

Line by line qualification support

Neyret Group validation and qualification teams are committed to meeting all standards that apply to clients’ businesses and that are implicit in their contracts.

These fully qualified teams run compliance checks according to the applicable standards, and conduct validation checks on customer equipment.  These checks are run against current regulations, specific client specifications and benchmarks for the sector in which the machine will be used. Detailed check reports are provided to the client, in addition to fully harmonised documents for the United States, Europe and Asian markets.

Pre-qualified systems

To meet the needs and requirements of the pharmaceutical and medical sectors, SGN and Lagniel machines are designed to be used in cleanrooms (from class 100 to 100,000), and to comply with all relevant GMP and FDA directives.

Neyret Group systems are first validated in-house, using ISO 8 standard cleanroom, generating approved documentation that is ready to be used for the next step of the qualification process.  The basic system, both hardware and software, is pre-approved according to GAMP 5 and is 21 CFR-compatible (part 11), as are all standard pre-developed process steps for specific applications, that can be selected from the Neyret Group ‘library’ of pre-qualified processed and checks.

Specific installation support

Neyret Group provides further support during and after installation, with a range of specific checks and tests that include:

• FAT (Factory Acceptance Testing): Qualification tests (static, dynamic and performance/quality run), conducted on Neyret Group sites prior to delivery,
• SAT(Site Acceptance Testing): Qualification tests (static, dynamic and performance/quality run), conducted after installation at client site.

Resources

Click on Neyret Group Qualification and Validation for further information.