DocShifter provides an enterprise SaaS platform that automates bulk file‑format conversion, rule‑based validation, and PDF/A/X/UA generation for regulated document submissions. Its modular services and REST APIs integrate with DMS solutions such as Veeva, Documentum, and SharePoint, delivering audit‑ready logs, encryption, and automatic correction of compliance issues. The solution reduces manual processing time and ensures submissions meet FDA, EMA, and PMDA standards.
Funding
Funding not disclosed
Founders
Product
Problem
Regulated organizations must convert, validate, and archive large volumes of documents to meet strict submission standards (e.g., FDA, EMA, PMDA). Manual handling of format conversion and quality checks is time‑consuming, error‑prone, and often leads to non‑compliant submissions. Existing document‑management systems lack built‑in, enterprise‑scale automation for these tasks.
Solution
DocShifter delivers an enterprise‑grade software platform that automates file‑format conversion, compliance validation, and PDF generation across multiple document types. Its modular solutions (PDF+, Any2Any+, Email+, DocValidator, PDFValidator, PDFInstruments, OCR) run on a scalable cloud architecture and expose RESTful APIs for seamless integration with RIM/DMS platforms such as Veeva, OpenText Documentum, Microsoft SharePoint, and Ennov. The platform applies rule‑based quality‑control checks to Word and PDF files, automatically fixes formatting issues, and produces submission‑ready PDFs that satisfy health‑authority requirements. Users can trigger processing via three‑click web interfaces, email monitoring, or batch jobs, while audit‑ready logs and encryption ensure data integrity and security. By centralizing conversion and validation, DocShifter reduces manual effort, shortens regulatory cycles, and guarantees consistent, compliant documentation across the enterprise.
Target Audience
Primary customers are compliance and document‑management teams in regulated sectors such as life‑sciences/pharma, banking, and insurance, as well as system integrators deploying Veeva, Documentum, SharePoint, or similar enterprise DMS solutions.
Features
- PDF+ engine that converts any source document to PDF/A, PDF/X, or PDF/UA with built‑in compliance presets for FDA, EMA, and PMDA.
- Any2Any+ service for bulk, rule‑driven conversion between over 200 file formats without user intervention.
- DocValidator and PDFValidator modules that scan Word and PDF files for styling, metadata, and regulatory rule violations, then auto‑correct identified issues.
- PDFInstruments for programmatic PDF manipulation (bookmarking, hyperlink insertion, page reordering) via a no‑code web dashboard or API.
- OCR component that extracts searchable text from scanned images, supporting multilingual character sets and preserving layout fidelity.
- Connectors and REST APIs that embed DocShifter functionality directly into Veeva, Documentum, SharePoint, Ennov, Generis CARA, and other DMS environments.
- Email+ monitor that watches inbound mailboxes, extracts attachments, and routes them through the conversion pipeline automatically.
- Cloud‑hosted processing with role‑based access control, end‑to‑end encryption, and audit logging to meet HIPAA, GDPR, and industry‑specific security standards.