GxP Vendor Audits
Elevate Your Compliance with Flexible GxP Vendor Auditing Packages
At Simple Quality Systems, we understand that ensuring vendor compliance is crucial for product development, testing, and manufacturing. Our GxP Vendor Auditing service offers flexible packages tailored to your needs, with discounts available for booking multiple audits in advance. Whether you need a single audit or comprehensive program management, we provide expert support to maintain compliance and ensure product quality. Schedule a free consultation to discuss how our services can benefit your organization.
Explore Our Auditing Services
Ensuring vendor compliance is crucial for product development, testing, and manufacturing. A compliant audit program is essential for proper vendor oversight and that is why I specialize in conducting initial and routine GxP Vendor Audits.
Let's explore how I can help identify potential risks and areas for improvement, ensuring that your vendors adhere to the highest quality standards. By choosing an audit package, you not only benefit from cost savings but also get consistent expert guidance and reporting.
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Ask about my Introductory Offers Available! ***First Audit Discount: Enjoy a special discount on your first audit. ***Audit Pack Discount: Opt for a pack of 4 audits and receive a total package discount, making it an even a more cost-effective option.
The simple audit process
This section provides a summary of what to expect from each step of the audit process if we were to work together, including some hypothetical timelines followed by a list of deliverables for each step. As a solo consultant, I can offer personalized attention and tailored solutions, ensuring a quick turnaround on tasks and reports. This approach guarantees that your organization receives the expertise needed for streamlining processes and achieving successful outcomes.
1. Audit Planning
Proper audit planning is essential to ensure the audit scope is clearly defined. During the Scoping Meeting, we will define the scope, objectives, and criteria of the audit, and discuss what standards will be followed. If the auditee doesn't have a QMS, we may audit against the Quality Agreement.
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​What to expect:
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Document review ahead of audit
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Takes approximately 8-16hrs
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Agree on KPIs
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Determine what procedures/stds will be followed during the audit
3. Audit Reporting
Includes drafting the report with findings and recommendations. Expect a quick turnaround to receive the final report. This guarantees that all relevant parties receive the necessary information efficiently and effectively.
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What to expect:
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Write up, follow up, deliverables - approximately 10-16hrs
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1-2 rounds of review
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Report finished in 1 week or less​
2. Audit Execution
The audit will start with the opening meeting. If onsite, the audit may include a facility tour. SMEs from your organization are welcome to join to provide specific expertise, if preferred. The audit concludes with the exit meeting, where I will provide a summary of observations, next steps, and proposed timelines.
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What to expect:
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Audit execution (8-24hrs, as approved)
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Onsite or remote
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Expect daily updates after audit concludes for the day
4. CAPA Plan and Follow-Up
CAPA Follow-up services are also available upon request. During this step, the CAPA plan implementation and tracking is managed on behalf of the client.​
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What to expect:
Expected time of completion will greatly vary depending on the number and complexity of the resulting CAPAs​​​
Audit Deliverables
Audit Planning
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Initial Meeting
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Scoping Meeting
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Audit Plan/Agenda
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Audit Confirmation letter
Audit Execution
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Daily end-of-day audit progress summary
Audit Reporting
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Post-audit Meeting
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Final report shared with sponsors (and auditee, if requested)
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Audit Certificate
Audit Follow-Up
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Agreed CAPA plan
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​CAPA follow up and tracking
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Effectiveness checks
Type of Audits
Audits can be conducted onsite or remotely. Onsite audits are recommended for laboratories or vendors with physical facilities involved in manufacturing, testing, or product development, as well as for initial vendor qualification processes. Remote audits may be suitable for routine qualification audits of low-risk vendors. Audits typically last 1 to 3 days. An SME from your team is welcome to join if specific expertise is needed or if there are particular areas of concern to address.
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Below are some examples of the types of audits covered with the service. Please schedule a free consultation to discuss your audit needs so we can tailor our approach to meet your specific requirements.
GMP Audits
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Excipients/Raw Materials
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Contract Mfg Facilities
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Storage and Distribution
CSV/Data Integrity
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Electronic records/signatures
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GxP-related systems
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Excel spreadsheets
GLP/GCLP Audits
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​Facility Inspections
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Testing Facilities
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Lab operations/housekeeping
GDP Audits
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Warehouse
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Supply chain and distribution
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Chain of custody
Let me manage your audit program
I offer ongoing and continuous monitoring of your audit program, including building the annual audit schedule, executing audits, monitoring metrics, and ensuring the program remains compliant. Additionally, I can assist in preparing your team for regulatory inspections by conducting mock inspections and delivering training workshops. Let's discuss your specific needs in detail and develop a service that stays within your budget while ensuring compliance.
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A great way to start revamping your audit program is by developing visual tools to help you monitor audit schedule, report status, CAPA follow-up, etc.
30 min
Free