Services you can rely on and quality you can trust
We review and release FDA-regulated products to the market, helping our clients save time and money while minimizing regulatory risks. Discover more about our Certified Batch Record Review Services.
Services you can rely on and quality you can trust
Call us today to find out how you can save time and money while reducing your regulatory risks with our certified Batch Record Review services.
Our Services
BatchWize provides Manufacturing Batch Record Review, Quality Assessment, Data Trending, and Lot Release services for FDA-regulated companies. We cater to industries including Food, Cosmetics, Wellness, MedTech, and Pharmaceuticals.
Manufacturing Batch Record Review
Your manufacturing Batch Record is reviewed by a Certified Quality Specialist. We provide a review summary and recommendation to release or not release.
We provide an easy to navigate batch record executive summary.
Batch Record Errors and product disposition are clearly identified.
Review of deviations, CAPAs, OOS, & nonconformances.
Ongoing Batch Record Review & Lot Release
Batch Record Review, Quality Record Review, and Lot Release. We'll do all the heavy lifting to free your team up for other needed activities.
We perform an ongoing review of your manufacturing batch records.
Coordination with the manufacturer for any needed information.
Lot Release and Lot-to-Lot Variation between batches.
Legacy
Data
Review
We'll upload, organize, & review legacy data to improve process understanding. We use validated tools to map your process, upload attributes, and trend process data.
Visually engaging reports and trends.
Process characterization, raw material performance, or process optimization.
Use of Quality by Design (QbD) and Manufacturing Excellence (MEx) tools
Data Trending, Assessment, & Visualization
We perform Al & non-Al data reviews using validated tools. This includes material data, process data, contract manufacturing data, or copacker data.
Tend raw materials and components across different manufacturing sites.
Certificate of Analysis (CoA) trending, visualization, & notification.
Manufacturing and supplier data review for Quality Audits.
Our goal is to ensure that your products meet cGMP requirements, product specifications and regulatory requirements BEFORE they are released for use.
Our primary focus is to reduce potential liability, improve product quality, & enhance process understanding. We accomplish these goals through Batch Record Review, Formal Lot Release, & Process Visualization by our certified quality specialists.
Release your products with our certified process
What to expect
Our four step process is streamlined to ensure the highest quality and safety, reducing FDA regulatory risks while saving you time and money.
Frequently Asked Questions
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BatchWize assists companies with Batch Record Review and compliance. Our specialized services focus on efficient and compliant reviews that improve process performance and overall quality. BatchWize works several different types of FDA-regulated products including food, cosmetics, supplements, medical devices, and pharmaceuticals.
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Batch Records are crucial documents in various industries like pharmaceuticals, biotechnology, food and beverage, and chemicals, where they are used to ensure product quality and consistency. They provide a detailed account of the production process for a specific batch of product, helping to maintain compliance with industry regulations and standards.
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The cost of review will depend on the size of your record; a batch record that is 30 pages will cost less than a batch record that is 300 pages. Contact us for a BatchWize demo and a custom quote. We’ll show you how Quality Specialists can help you efficiently outsource your Manufacturing Record Review.
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Yes, we will perform Review By Exception (RBE) based on the client’s established criteria and product specifications. If you need to verify/validate a review by exception mechanism, we are happy to conduct the second party data verification for you.
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Yes, we review electronic records including Electronic Batch Records (EBR.) BatchWize also reviews paper records, scanned PDFs, electronic spreadsheets & digital data.
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Yes, we review deviations, nonconformances, OOS, OOT and CAPAs according to FDA guidelines and the customer’s requirements. We look to see if the event is clearly documented, if there was an investigation, if the root causes (or causes) were determined and if there were corrective/preventive actions indicated. Depending on the event, we may also inquire if the responsible parties were informed of the event or if the event was communicated within the company. At the client’s request, we will also verify the effectiveness of the actions taken.
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Non-compliance with record-keeping requirements, particularly those mandated by regulatory bodies like the FDA for medical devices or other regulated industries, can lead to a range of consequences. These consequences can vary in severity based on the nature and extent of the non-compliance. Consequences may include: regulatory actions, financial impacts, loss of business, market access and growth consequences, and the loss of customer trust.
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Batch Record review helps to ensure that your product meets regulatory requirements, quality standards and product specification BEFORE the products are released to the market. Batch Record Review can help to avoid costly recalls or the distribution of adulterated products.
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Companies that do not follow FDA regulations and cGMPs may lose their product approvals/product registration, or they may lose the ability to import, market or distribute their product in the US. In order to maintain market access, companies must keep manufacturing records and they must supply safe, effective, unadulterated products that meet applicable packaging, labeling, and testing requirements.
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We take your batch data and upload it to validated external tools. We then present this data to the client to improve process and product understanding. Depending on the data, we should be able to identify trends, material impact, and verify critical parameters.