Have questions?

Yes - the software is designed to achieve full compliance with 21 CFR part 210 and 211 and ISO 13485 standard requirements. Our goal is to design a software that not only meets, but exceeds, the global regulatory expectations for our clients. 

Every component of the software is rigorously tested and validated to ensure full compliance to 21 CFR reuirements. 

Each data field is individually tested for detection accuracy, and challanged against robust test scripts that are developed based on  current FDA guidance. We work with our clients every step of the way to ensure a successful computer system validaiton. 

A digital template is built based on an existing client document formats, and dynamic fields are created to mirror handwritten entry fields. Acceptance critera is then embedded within the dynamic fields. The software uses this to evaluate production data inputs to ensure conformace to data type, format, and predefined acceptable parameters. When the validated system detects an incorrect or incomplete entry, it flags the error for review in real-time. 

Speed of ROI matters. autoGDP takes a unique approach to implementation, which sets us apart from other EBR service offerings. 

Our software is designed with accelerated adoption in mind. The technology seamlessly integrates with current paper-based formats, and provide results in an export to our client's current paper templates. While timelines can vary based on the volume of documents converted, typically clients can begin to attain the full benefits of electronic record management within the first 60 days of adoption. 

autoGDP can be onboarded faster, and easier, than other electronic batch record offerings. Our focus on ease of adoption enables us to provide services at a lower cost than our competitors. 

Our goal is to determine the best-fit approach to provide our clients an exemplary software. To recieve a quote that is tailored to your specific needs, please contact us.

A batch record is a compilation of all the regulated documents used to record the manufacturing  steps and related activities to create each lot of healthcare product. Batch records are required by the FDA and other global regualtory authorities. Around 90% of the industy uses paper batch records, and each handwritten record must be reviewed  prior to final product release to market. autoGDP's electronic batch record solution aims to modernize this process.