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QUALITY MANAGEMENT / FDA cGMP
Quality.
By design.
Stronger systems.
Consistent practice.
Quality Management System and cGMP consulting, from procedures and validation
to FDA audit readiness.
Build Establish Validate Improve
01 / QUALITY MANAGEMENT
Build
quality into work.
Quality Management Systems & current Good Manufacturing Practice.
01 / FDA
QMS & cGMP Development
PCG works within your organization to create and develop cGMP processes, strengthen internal systems,
improve quality, and address compliance issues. Product characteristics and applicable FDA requirements shape
the approach.
02 / FDA
FDA Requirements & ISO Standards
Our work addresses relevant requirements under 21 CFR Parts 820, 210 and 211, alongside ISO 9001, ISO
22716 and ISO 13485 considerations. FDA’s QMSR, effective February 2, 2026, amends Part 820 and
incorporates ISO 13485:2016 by reference. Applicable FDA requirements and product-specific obligations still
need to be addressed.
02 / QUALITY MANAGEMENT
Establish
the foundation.
People, procedures, and controlled records.
01 / FDA
SOPs, Training & People
SOP drafting and implementation; training; management; personnel qualification and staffing.
02 / FDA
Quality Systems & Documentation
Document management; Electronic Quality Management Systems; Part 11 compliance; manufacturing batch
records; packaging batch records; inventory management.
03 / QUALITY MANAGEMENT
Validate
and control.
Consistent processes and reliable controls.
01 / FDA
Validation & Qualification
Process validation; cleaning validation; equipment qualification and validation; analytical method validation.
02 / FDA
Laboratory, Materials & Suppliers
Laboratory controls; raw material testing and controls; environmental monitoring; supplier qualification program.
04 / QUALITY MANAGEMENT
Prepare.
Respond. Improve.
Audit readiness and regulatory response support.
01 / FDA
Audit Readiness & Representation
On-site mock audits for CFR 820, CFR 210, CFR 211 and MoCRA; internal audit programs; representative role
upon audit; regulatory liaison during FDA audits.
02 / FDA
Investigations & Corrective Action
Investigations; CAPA; FDA 483 observations; warning letter response; recalls and corrections. We help develop
appropriate responses and comprehensive strategies to move the organization forward.
CONTACT US
Plan your
next step.
Discuss your quality systems, manufacturing processes, and audit readiness with Provision Consulting Group.