GMP & Quality Approach

Benoit Industrial Solutions (BIS) supports regulated and GMP-adjacent environments by operating within established client systems and controls.

BIS performs services in accordance with client-approved procedures, permits, safety requirements, and Quality Management Systems (QMS). BIS does not replace, override, or operate independently of client quality systems.

Quality System Alignment

• BIS does not maintain an independent GMP Quality Unit

• All work is performed under the client’s QMS

• GMP decision-making authority remains with the client

• No product release or validation authority is assumed

BIS activities are limited to authorized scope and are executed to support, not modify, client quality frameworks.

Execution & Verification

BIS emphasizes disciplined execution and verification of work performed:

• Work is completed within approved scope and authorization

• Activities are verified prior to close-out where operationally feasible

• System behavior is observed following adjustments or maintenance

• Unexpected conditions are escalated to the client for direction

Verification is intended to confirm system stability at the time work is completed.

Documentation Practices

• Service activities are documented clearly and accurately

• Documentation reflects work performed and observations made

• Client retains ownership of GMP records

• BIS records support client documentation requirements and do not replace them

BIS documentation is intended to assist client decision-making and recordkeeping.

Deviations & Change Control

• BIS does not initiate deviations or change controls independently

• Any conditions outside approved scope are communicated immediately

• Further action is taken only with client authorization

This approach is intended to maintain compliance and prevent unintended GMP impact.

Risk Awareness

BIS approaches work in regulated environments with an emphasis on:

• Scope control

• Procedural adherence

• Clear communication

• Conservative decision-making

This structure is designed to reduce operational and compliance risk during service activities.