Paper documents are a risk. 
It's time to upgrade.

We provide software to electronically represent pharmaceutical and medical device manufacturers' production batch records.

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A new solution designed to solve an old industry problem

Our Focus 

We are revolutionizing production record management systems, traditionally maintained on handwritten paper forms,  with current technology.


We are automating the review of biotech's handwritten documents through the use of machine learning and intelligent character recognition (ICR) technology. Our solution creates a seamless transition to paperless electronic batch record (EBR) management by utilizing common documents used on production floors today.


Our unprecedented approach is fully compliant with 21 CFR regulation and enables a new dimension of quality and operational insights for partners.

A novel SaaS for an old problem

Increase Product Safety

Electronic batch record software empowers our clients to achieve a shared goal: consistently ensuring the highest product quality. 
autoGDP enables automated error detection and enhanced quality assurance in biotech's highly regulated environment.
 

Accelerate Batch Release

Recognized now more than ever, it is vital that essential medical products are manufactured and distributed as quickly as possible. autoGDP allows firms to release finished product batches to market in 46% less time than conventional paper review process. 

Automate Record Review

The industry's shift from handwritten documents to electronic records is coming. +90% of production facilities today still utilize fully paper or paper-hybrid record management systems. We are uniquely designed to accelerate this transition.
 

Increase product safety

Electronic batch record software empowers our clients to attain our shared goal: consistently ensuring the highest product quality possible. 

Deliver product faster

Using autoGDP's 21 CFR part 11 validated approach to electronic batch record management, quality assurance teams are able to review and release finished batches in 46% less time than conventional paper review processes. 

Upgrade to electronic document management

Unlike our competitors, our software seamlessly mirrors current paper batch documents- a minimally invasive approach that does not require clients to step away from ongoing standard operations. 

The modern electronic record advantage

Upgrading quality assurance, without disrupting current operations

  • Automatic error detection

    autoGDP provides the ability to identify and resolve deviations that can impact product quality in real time. Through defined acceptance criteria and process-step parameters, errors are automatically flagged at the time of data entry instead of post-production document review. Transparency is optimized through field history tracking to create a comprehensive audit trail of unique user profiles for each batch record.  This provides a full audit record of updates and error corrections in a compliant way. 


    Structured electronic batch data offers new dimensions of quality control. Real-time trend reporting of critical quality attributes (CQAs) can be utilized to identify the corrective or preventive actions necessary to continually ensure the highest product quality and optimal operating processes. 

  • Improved data integrity

    Data integrity is consistently the top focus of the FDA, international regulatory agencies, and our clients’ quality assurance teams. To ensure superior adherence to federal guidance, autoGDP fully compliant to 21 CFR regulation.   All data entries are electronically timestamped, recorded, and are readily available for reporting. Unique user profiles and automated quality checks ensure that the data entered is complete, traceable, and in the correct format. 


  • Paperless manufacturing

    To ensure conformance to FDA  requirements, pharmaceutical, medical device, and consumer product manufacturers currently manually document each step of the batch production process in a batch record. Currently, this is completed through handwritten records that must be manually reviewed for production errors prior to final product release to market. 


    By utilizing autoGDP’s validated electronic batch record solution, our clients will substantially reduce product release cycle time, automate error detection, and enhance data integrity - all while managing essential documents in an efficient, modern, and reliable way. 

  • Increased regulatory compliance

    Built in accordance with current FDA guidance, autoGDP is designed to meet and exceed 21 CFR part 11, GAMP 5, and ISO 13485 standards. The software provides time-stamped data entries, complete audit trails, e-signature capabilities, and robust security features. We handle the system validation throughout the lifecycle, so our clients can enjoy the full benefits of an electronic batch record without the need of a dedicated IT validation team. 

  • Decreased product time to market

    autoGDP’s electronic batch record solution error-proofs key components of data entry and eliminates common production mistakes, such as missing or incomplete documentation, that compound to result in delays to market release. When deviations inevitably occur, our electronic process automatically detects errors to minimize impact to release cycles. 


    By one competitor survey, electronic batch records decrease the number of days on hold for an equivalent paper-based process by 54%.

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About autoGDP

autoGDP is a technology company that provides enterprise solutions for healthcare and consumer product industrial manufacturers.  We created software to electronically represent  paper-based production records and digitally transform current  document management systems. With an intense focus on client adoption and current FDA guidance, we have built a solution that automates the industries' common Good Documentation Practices (cGDPs) and enables our clients to produce healthcare products faster, and safer, than ever before. 
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