BatchWize Services To Meet Your Needs

At BatchWize, we have the ability to customize our services to meet our client’s needs. Some clients benefit from a thorough manufacturing batch record review, some clients need help reviewing nonconformances, and still others want a closer look at their manufacturing data using trending and process visualization tools. 

Summary

This article discusses the services provided by BatchWize LLC. BatchWize is a skilled consulting group specializing in Manufacturing Batch Record review and product release. We are focused on getting quality products to market and keeping them there. For services outside of our scope, we work with some exceptionally talented partners.  

Article Contents

1. Overview

2. Manufacturing Batch Record Review & Lot Release

3. Ongoing Batch Record Review

4. Quality Record Review

5. Data Trending and Visualization 

6. Our Approach

1. Overview

At BatchWize we pride ourselves on delighting our customers with our unparalleled focus on quality and efficiency. We look at each batch of product as if it were our own. BatchWize works with customers who make food products, herbal products, cosmetics, supplements, medical devices, and pharmaceuticals to make sure that quality products meeting the company’s requirements are released to the marketplace. We started with Batch Record and Quality Record review, but we can do so much more!

    
Our Primary Services Can Be Broken Down Into 4 Categories:

1. Single Batch Record Review

2. Ongoing Batch Record Review and Lot Release

3. CAPA, Deviation, Nonconformance Review

4. Data Trending and Visualization

Manufacturing record review and lot release, quality record review, data trending and visualization for FDA regulated products

2. Manufacturing Batch Record Review and Lot Release

We perform on demand Batch Record review for our clients, exactly when they need it. Some clients need support when transitioning to a larger facility or when there are changes in staffing. Other clients utilize BatchWize to review Manufacturing Batch Records and redirect their internal staff to other projects. 

Need a little help with product release? Want to make sure your product isn’t expiring in the warehouse as it sits on the shelf? We can help with that too! Our team can review manufacturing records and recommend for release/not release based on our findings. We can release products based on our own internal procedures, or train to our client’s procedures (SOPs/WIs).

3. Ongoing Batch Record Review

BatchWize can perform ongoing Batch Record review and lot release for our clients in the medical device, drug, cosmetic, food, supplement, and wellness space. We specialize in products that are regulated by the U.S. FDA. We work with manufacturers, contract manufacturers, copackers, repackers, packaging companies, etc. Our ongoing Batch Record review service allows companies to reduce costs and gain efficiency. We will work directly with the manufacturer or contract organization to ensure we get the data that we need!

4. Quality Record Review: CAPA, Deviation, Nonconformance

We take a holistic approach to Batch Record review, and our team is trained to review deviations, nonconformances, out of specifications (OOS), out of tolerances (OOT), Corrective and Preventive Actions (CAPA), and other quality investigations. We can review Quality Records as part of Batch Record Review or as a stand alone service. Do you have a backlog of CAPAs that need review? Give us a call. 

5. Data Assessment, Trending & Visualization

BatchWize helps clients understand their manufacturing process and product quality through data trending and visualization. We can create simple trends of product test data, evaluate data from Electronic Batch Records, or create models of your existing manufacturing process (raw materials, unit operations, quality attributes, specifications, risk assessment) using fully validated software tools.  For our medical device, pharmaceutical, and biotech clients we only use fully validated 21 CFR Part 11, EU Annex 11 compliant tools. We partner with companies like MasterControl and QbDVision to bring our clients the best-in-class software tools.  

Need to review data before your next audit or as part of an internal review? Interested to see how your raw materials are changing?  Want to see your COA data trended by lot? Give us a call. We perform efficient data reviews based on our client’s needs.  

6. Our Approach

At BatchWize, we pride ourselves on taking a practical approach to product quality. We understand the challenges of manufacturing in a regulated industry. We look at every product as if it were our own, and we take an honest and open approach to all our activities. We focus on customer communication, organization, and thoroughness. We want to put our customers in the best possible position, because your wins are our wins too!   

Need More Help Than What We Offer?  

BatchWize has partnered with exceptional service providers to assist our clients with Regulatory Filings, Risk Management, Validation, FDA Readiness, Quality Audits, QMS Development, Electronic Manufacturing Records, and more. Check out some of our trusted partners:

Spark  Exemplar  QbDVision  MasterControl   Sage BioPartners