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QC Automation Solutions

DDi drives operational quality with automation solutions designed for BioPharma and Medical device companies. For over 8 years, our QC solutions reduce cycles, cut over 70% of manual efforts, boost consistency, minimize error margins, and safely speed up turn-around-time across all functions (Clinical, CMC, Non-Clinical, Labelling, Tech Documentation, Quality).

REGai does this in 3 ways (based on Client Preference and Use Cases):
  • Zero AI solution (Rule-based)
  • AI solution (with local models and no 3rd party AI connectors needed)
  • Hybrid
QC-Automation-Solutions-app-mock

Automation That Amplifies People

REGai augments human intelligence, helping team focus on decision making and compliance
while Automation handles manual/repetitive tasks.

8+

Years QC Experience

70%+

Manual Effort Reduced

65%

Lower cost. Higher ROI

100%

Traceability
(Compliance-ready)

Automating Quality Control (QC)

Deploying smart automation to reduce cycle latencies, improve consistency and minimize
structural operational risk.

consistency-checks

Consistency Checks

Ensure terminology, values, abbreviations, citations, and references remain consistent across lengthy dossiers and multiple files.
compliance-verification

Compliance Verification

Automatically compare content against global regulatory expectations and internal quality standards seamlessly.
faster-review-cycles

Faster Review Cycles

Identify issues early and recommend corrections automatically, helping teams achieve right-first-time submissions.
style-guide-application

Style Guide Application

Instantly apply pre-configured corporate or regulatory templates to raw text to ensure brand and agency alignment.
word-pdf-check

Word and PDF checks

a Library of over 600 checks covering formats to grammar tables checking to layouts to TOC/bookmarks/hyperlinks and more
auto-fix

Auto-Fix

Don’t stop with QC. Select Auto-Fix option to fix word and pdf when rrors found to save time further.

QC Automation Solutions

pharma-biotech

Pharma / Biotech

Regulatory Affairs

DDi’s sophisticated QC automation eliminate errors in global regulatory dossiers, verifying dynamic submission workflows, enforcing cross-regional compliance, and ensuring absolute pinpoint precision.

Publishing

Streamline regulatory publishing compilation with automated validation setups. Efficiently check hyperlinks, text formatting, font properties, bookmark loops, and eCTD structure criteria rapidly.

Medical Writing

Automate tedious quality checks on technical, clinical, and scientific scripts. Instantly evaluate structured style guidelines, complex reference listings, and table data consistency.

Labeling

Optimize tracking metrics and prevent content drift across dynamic safety updates, package graphics, and local label definitions using systemic cross-comparisons.

CMC

Ensure high-level cross-document alignment across critical CMC authoring drafts, data summaries, product certificates, safety inserts, and global requirements simultaneously.

medical-device

Medical Device

Tech Documentation Automation

Optimize technical file compilation structures securely using agentic AI loops. Reduce validation lifecycles for MDR/IVDR compliance protocols and optimize product data accuracy levels.

Label QC Automation

Leverage automated AI structures to rapidly cross-examine device labels, UDI structures, manufacturing signs, and clinical instruction text with strict regulatory frameworks seamlessly.

Clinical

Accelerate extensive clinical evaluation report reviews using intelligent automation. Validate raw medical metrics safely against core trial evidence documents without error margins.

How can you use REGai QC solutions ?

REGai Tool
(UI Interface)

Checks/Rules & parameters setup, (mapping diff checks to diff type of documents), file upload, run jobs instantly, download updated files

MS Word / 365

Plugins /add ins are provided with customized ribbons to perform fixes while in the document

Hybrid

Some steps done by batch while other steps done interactively (like updating hyperlinks manually) or changing parameters and re-run jobs

Your Current tools
(with interface)

With interface to your current EDMS/RIM, batch scheduling can be done (hourly, daily)

Pull files, Auto Fix/QC and upload back to Source (either check-in or create folders)

Security & Privacy

Enterprise-grade security architectures
ensuring total privacy and data control.

never-trains

It never trains on your data

REGai uses pre-trained AI models hosted on a private system, not public ones like ChatGPT, Claude etc. Your firm’s data is never used to improve the model or shared with others. We also use a secure, private connection between our systems, ensuring data is never exposed to public internet traffic or 3rd Party systems via APIs.
secure-environment

It lives inside DDi’s secure environment

Everything stays inside our SOC 2 Type 2-compliant infrastructure with encryption, role-based access controls, and other enterprise-grade security features. This keeps your data secure and reduces the number of vendors touching it, which means simpler compliance workflows and stronger control.

Compliance

Providing a comprehensive compliance program
with certifications and attestations is integral to
this mission.

soc-type-2

SOC 2 Type 2

Our platform maintains robust SOC 2 Type 2 operational audit attestations ensuring rigorous oversight controls.
gdpr

General Data Protection Regulation (GDPR)

Strict structural adherence to GDPR mandates to secure private details and control user data rights perfectly.
hipaa

HIPAA compliant

Full deployment of safety and physical controls required to protect electronic Protected Health Information (ePHI).
penetration-testing

Penetration testing

Continuous internal and external penetration testing protocols performed by certified security experts regularly.
privacy

Privacy

Comprehensive data minimization frameworks and strict privacy guidelines established across all system modules.

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BioPharma_Medical-Writing-QC-Automation

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Label-Compliance-QC-Automation

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Frequently Asked Questions

faq-question

What are DDi Quality Control (QC) Automation Solutions?

DDi QC Automation Solutions (powered by the REGai platform) are automated compliance and quality verification tools built specifically for BioPharma, Medical Device, Consumer Health, and Chemical companies. The platform automates over 600 structural, grammatical, layout, and regulatory checks on global submission dossiers, technical files, and clinical reports across functions such as Regulatory Affairs, Medical Writing, Publishing, Labeling, and CMC.

faq-question

What key metrics and benefits do DDi QC Automation Solutions deliver?

According to DDi, their QC automation solutions deliver four main operational benefits:

  • Over 70% Reduction in Manual Effort: Eliminates repetitive, manual document review tasks.
  • 65% Lower Costs: Maximizes return on investment (ROI) by lowering validation operational expenses.
  • Faster Review Cycles: Reduces cycle latencies and speeds up turnaround times (TAT).
  • 100% Traceability: Maintains compliance-ready audit trails for global regulatory standards.
faq-question

What technologies power DDi’s REGai QC Automation platform?

DDi’s REGai platform operates via three flexible deployment modes based on client preferences and specific use cases:

  1. Zero AI Solution: Purely rule-based checks and parameter setups.
  2. AI Solution: Uses local, pre-trained AI models with zero reliance on 3rd-party AI connectors.
  3. Hybrid Solution: Combines automated batch scheduling with interactive manual user controls.
faq-question

What specific quality control checks can DDi automate?

DDi automates a library of over 600 specific checks for Microsoft Word and PDF files, including:

  • Consistency Checks: Alignment of terminology, numeric values, abbreviations, citations, and references across multi-file dossiers.
  • Compliance Verification: Automatic cross-examination against internal quality guidelines and global regulatory standards
  • Document Formatting & Style Guide Application: Instant application of corporate or agency-specific templates, font properties, margins, and layouts.
  • Structure & Navigation Checks: Hyperlinks, bookmark loops, table formatting, table of contents (TOC), and eCTD criteria.
  • Auto-Fix Capabilities: Automatically corrects detected Word and PDF errors without manual intervention.
faq-question

How can teams integrate and access DDi’s QC Automation tool?

DDi supports four primary integration methods:

  • REGai Web UI Interface: Direct file upload, check/rule parameter configuration, and job running via web interface.
  • MS Word / Microsoft 365 Plugin: Add-ins with customized ribbons to perform direct fixes within active documents.
  • EDMS / RIM System Integration: Direct interface with existing Electronic Document Management Systems (EDMS) or Regulatory Information Management (RIM) tools for automated batch pulling, checking, auto-fixing, and re-uploading.
  • Hybrid Workflows: Combining automated batch jobs with interactive manual adjustments.
faq-question

How does DDi QC Automation assist BioPharma and Biotech teams?

DDi supports BioPharma through five core functional areas:

  • Regulatory Affairs: Eliminates errors in global regulatory dossiers and cross-regional compliance workflows.
  • Publishing: Validates eCTD structures, formatting, fonts, bookmark loops, and dynamic hyperlinks.
  • Medical Writing: Evaluates style guidelines, reference lists, and tabular data consistency in scientific scripts.
  • Labeling: Prevents content drift across safety updates, local label definitions, and package graphics.
  • CMC (Chemistry, Manufacturing, and Controls): Ensures cross-document data alignment across authoring drafts, summaries, and product certificates.
faq-question

How does DDi support Medical Device Quality Control?

DDi provides medical device teams with targeted automation tools:

  • Technical Documentation: Uses agentic AI loops to structure technical file compilations for EU MDR/IVDR compliance.
  • Label & UDI QC: Cross-examines Unique Device Identification (UDI) structures, device labels, and clinical instructions for use (eIFU) against regulatory frameworks.
  • Clinical Evaluations: Accelerates Clinical Evaluation Report (CER) reviews by validating medical metrics against trial evidence documents.
faq-question

Does DDi use customer data to train AI models?

No. DDi operates on a strict “Never Trains On Your Data” policy. REGai uses private, pre-trained AI models hosted in dedicated environments. Client data is never used to improve public or proprietary AI models, nor is it exposed to 3rd-party system APIs or public internet traffic.

faq-question

What security and compliance certifications does DDi hold?

DDi’s QC Automation Solutions operate within an enterprise-grade infrastructure adhering to the following certifications and security controls:

  • SOC 2 Type 2: Operational audit attestations for rigorous oversight controls.
  • GDPR Compliant: Adherence to data protection and user privacy regulations.
  • HIPAA Compliant: Safeguards electronic Protected Health Information (ePHI).
  • Penetration Testing: Regular internal and external security audits by certified penetration testing experts.
The First Step

Let's talk about how DDi can help you