Services you can rely on and quality you can trust
Quality and Regulatory Compliance Consulting Services including the review and release of FDA-regulated products. We help our clients save time and money while minimizing regulatory risks.
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
We work with Pharmaceutical, Medical Device, Software, Food, & Wellness products.
Batch Record Review & Product Release
We review and release FDA-regulated products to the market; freeing up your team for other needed tasks.
Quality & Regulatory Consulting
Full service quality consulting, including quality system development, Quality Audits, Training, & Quality Record Review.
Legacy Data
Review
We use validated tools to upload, organize, & review legacy data to provide trends & improve process understanding.
Data Trending, Assessment, & Visualization
Trending of raw materials, components, & manufacturing data across multiple lots or sites. Al & non-Al data review.
At BatchWize all of our services follow a central theme. We believe in helping companies bring high quality, compliant, products to market while reducing costs and regulatory risks. We use our skills and expertise to assist with quality system development, quality record review, GMP product release, legacy data review and data visualization for process improvement.
Our primary focus is to reduce potential liability, improve product quality, & enhance process understanding.
Quality Services You Can Trust
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.