cGMP Compliance & Audit Support

Build, maintain, and demonstrate compliance across your company and supply chain.

cGMP Compliance Solutions

Accorto helps regulated companies develop and maintain practical quality systems that meet US FDA and applicable industry requirements. Whether you manufacture products internally or rely on contract manufacturers and other third parties, your quality system needs to define how quality is managed, documented, and maintained throughout the product lifecycle. 

We help regulated companies: 

  • Build and optimize Quality Management Systems
  • Identify and remediate compliance gaps
  • Prepare for FDA, client, internal, and certification audits
  • Establish oversight of contract manufacturers and suppliers
  • Develop inspection-ready SOPs and documentation

  • Manage CAPAs and corrective actions

  • Qualify and audit suppliers and contract partners
  • Train quality personnel and leadership
  • Add experienced quality support without a full-time hire

Table of Contents

Regulations and Standards We Navigate

Accorto supports quality and compliance programs across regulated industries and applicable frameworks, including: 

01 fda qmsr iso 13485

FDA Quality Management System Regulation (QMSR) / ISO 13485 

02 iso 17025

ISO 17025 

03 iso 9001

ISO 9001 

04 21 cfr 210 211

21 CFR Parts 210 and 211 

TPMP manufacturing

TPMP

06 cosmetic gmp mocra

Cosmetic GMP requirements under MoCRA 

When multiple standards apply, we help companies build a quality system that addresses them together rather than treating each requirement in isolation. 

Quality and Compliance Services 

We assess your current quality processes, procedures, responsibilities, and documentation against the requirements that apply to your products and business. Then we work with your team to prioritize gaps and build a practical remediation plan. 

Prepare for an upcoming audit or inspection, or maintain readiness between them. Accorto supports: 

  • Internal audits. Evaluate procedures, policies, documentation, quality responsibilities, and risk-management practices, and translate findings into corrective actions. 
  • Client audits. Prepare for customer or partner audits driven by contractual or quality requirements. 
  • Regulatory inspections. Prepare for and provide support during FDA and other regulatory inspections. 
  • Certification audits. Prepare for ISO and other certification audits and support your team during the audit. Accorto prepares organizations for certification but does not issue certifications. 

Build or improve a Quality Management System appropriate for your company’s products, activities, regulatory responsibilities, and operating model. 

Whether you have your own manufacturing operations or outsource manufacturing, your QMS should clearly establish responsibilities, controls, documentation, escalation procedures, and oversight throughout the product lifecycle and supply chain. 

We specialize in developing right-size systems tailored to your organization’s unique operations, ensuring your QMS meets all necessary regulatory requirements without being overly burdensome. 

Outsourcing production does not mean outsourcing quality oversight. 

Accorto helps companies establish processes for qualifying, approving, monitoring, and auditing contract manufacturers, suppliers, laboratories, and other critical third parties. We also help define quality responsibilities and the documentation needed to demonstrate ongoing oversight.

Performing as intended once isn't the same as performing as intended reliably.

Accorto helps you document that equipment, processes, systems, and other critical elements of your operation perform as intended, and continue to perform as intended over time, through validation and qualification activities appropriate to their risk and complexity. 

A CAPA (Corrective and Preventative Action) that doesn't resolve the underlying issue is just paperwork. 

Accorto supports investigations, root-cause analysis, corrective and preventive actions, implementation, documentation, and closure so CAPAs address the real cause and withstand regulatory scrutiny. 

Procedures that don’t reflect how your team actually works simply won’t get followed, and unfollowed procedures lead to audit findings. Accorto develops SOPs around how your company actually operates, creating documentation that is practical for your team and defensible during an audit or inspection.

A quality system is only as strong as the people executing it. 

Accorto trains quality managers, operational personnel, and senior leadership on the quality requirements and responsibilities relevant to their roles, so compliance is understood and practiced, not just documented. 

Add experienced quality leadership without hiring a full-time quality manager. 

Accorto provides remote, part-time quality leadership to establish, manage, or supplement your existing quality function.  

An unannounced FDA audit doesn’t wait for you to be ready. The moment you get the call, the clock starts, and many manufacturers don’t have a team standing by that can respond in kind. We do.
Our Rapid FDA Audit Support program has a team on standby, ready to mobilize the moment you’re notified. Call us, and we’re with you immediately.

You Need a QMS Even When You Outsource Manufacturing 

A company does not need to own a manufacturing facility to need a quality system. 

Many regulated product companies rely on contract manufacturers, laboratories, suppliers, warehouses and distributors, or other third parties to perform critical activities. Those relationships create their own quality-management requirements. 

As an organization responsible for a regulated product, your QMS needs to be able to show regulators how your company: 

  • Selects and qualifies critical partners 
  • Defines quality responsibilities 
  • Reviews and approves appropriate documentation 
  • Handles deviations, complaints, and other quality events 
  • Manages CAPAs and changes 
  • Monitors supplier and contract manufacturer performance 
  • Conducts or commissions audits 
  • Escalates and resolves quality issues 
  • Maintains records demonstrating appropriate oversight 

When You May Need Quality and Compliance Support

fda manufacturing audit

Organizations typically engage Accorto when they are: 

  • Launching a regulated product or company 
  • Building a QMS for the first time 
  • Outsourcing manufacturing and establishing quality oversight 
  • Adding or changing a contract manufacturer or critical supplier 
  • Preparing for an FDA or other regulatory inspection 
  • Preparing for a customer or certification audit 
  • Addressing Form 483 observations or other findings 
  • Correcting documentation or CAPA deficiencies 
  • Preparing for ISO certification 
  • Scaling operations or entering new markets 
  • Operating without sufficient internal quality resources 
  • Trying to maintain inspection readiness between audits

Why Compliance Can’t Wait Until Your First Inspection 

Regulators and auditors expect more than a compliant product or manufacturing facility. They expect evidence that the company has established and followed appropriate quality processes over time. 

That can include procedures, training records, supplier controls, quality agreements, deviations, CAPAs, complaints, change controls, audit records, and other documentation demonstrating how the company manages quality in its daily operations. 

The goal is therefore not simply to prepare for an inspection. It is to operate in a way that makes quality and inspection readiness part of normal business. The benefit of doing that from day one is that it can still be done without issue on day 366. 

cGMP Compliance FAQs

Whether it’s to satisfy FDA engagement, resolve internal issues, close inspections faster, prevent observations from recurring across visits, or ensure that market access isn’t interrupted, these documents become critical for identifying the source of the problem, when it was discovered, and detailing how it was resolved. 

They are the lifeline to restoring good standing with the agency and the end consumer alike. 

FDA inspection timelines depend on your industry, product classification, and the risk level of the product itself. Some products require a facility inspection before market authorization; for others, the first inspection may not happen until well after the product is on the market, and timing is driven by routine risk-based surveillance rather than a fixed schedule. For a more detailed answer specific to your product and pathway, reach out and our experts can advise. 

These audits entail more than a walkthrough of your facility. Inspectors expect to see documentation proving ongoing compliance with your applicable standards, not just clean equipment and organized shelves. 

Without documented processes, incidents, and corrective actions along the way, a company can fail an FDA inspection on paperwork alone, even if the facility itself passes with flying colors. 

Manufacturers can end up out of compliance for a variety of reasons, operational challenges like resource constraints, no documented process for incidents and corrective actions, or quality functions bolted on after the fact rather than built in from the start. 

But underlying most of these is the same root cause: treating compliance as a launch milestone rather than a daily operating discipline. 

Typically, when the FDA identifies a compliance issue during a facility inspection, the first formal step is a Form 483, a written list of observations the investigator issues at the conclusion of the inspection. Each observation describes a condition the investigator believes may violate applicable regulations (e.g., CGMP, QMSR, or other requirements depending on the product type). Companies are typically given a short period to respond in writing describing their planned corrective actions. FDA reviews that response, along with the severity and pattern of the observations, to decide whether further action is warranted.

Form 483s are not automatically made public, though they are obtainable through a FOIA request, and redacted versions are sometimes published after the fact.

Companies that receive a 483 are expected to implement corrective actions and keep the agency updated until the findings are resolved. If that response falls short, the FDA can escalate to a Warning Letter, a more formal notice that the agency does post publicly, putting real continuity of market access at risk. 

Beyond a Warning Letter, the agency has further options. A consent decree places a company’s operations under court-enforced oversight, often halting production until specified conditions are met. An import alert allows the FDA to detain products at the border without physical examination, effectively closing the US market to a foreign manufacturer. A recall removes product already in distribution, whether initiated by the company or requested by the agency. 

Each of these carries a longer recovery period than the one before it, and each becomes part of the public record. 

How We Work With You

01 assess@3x1. Assess

We start by understanding your products, business model, internal operations, outsourced activities, applicable requirements, existing quality systems, and immediate compliance risks.

02 prioritize@3x2. Prioritize

We identify gaps and determine what requires immediate remediation versus longer-term improvement.

03 implement@3x3. Implement

Accorto works alongside your team to develop procedures, documentation, controls, corrective actions, training, and quality systems appropriate for the way your company actually operates.

04 maintain@3x4. Maintain

When ongoing support is needed, Accorto can supplement your quality team or provide fractional quality management to help maintain compliance and oversight over time.

The initial assessment is critical for guiding the regulatory strategy that defines the engagement. Companies often approach us expecting a short-term project and find they need ongoing support, or the reverse, so the scope follows what the assessment finds rather than the assumption it started with. 

Practical Quality Systems Built Around Your Business

Quality documentation only works when it reflects the operation behind it.

Accorto develops right-sized quality systems and documentation around each client’s actual products, operations, partners, and regulatory obligations rather than deploying out-of-the-box, overly burdensome systems. The objective is to meet applicable requirements while creating a system your organization can realistically operate and maintain. 

Strengthen Your Quality System Before a Gap Becomes a Finding 

Whether you need to build a QMS, strengthen oversight of contract manufacturers, close specific compliance gaps, prepare for an upcoming audit, or add experienced quality resources, Accorto can tailor the engagement to your company's needs. 

Talk with Accorto's quality and compliance team about your requirements. 

Contact Us

Fill out our form to discuss how Accorto can assist you with your cGMP compliance and facility audit needs today. We’ll be in touch within 1-2 business days!