Client Success Story

Building a Zero-Defect Document Infrastructure for a Growing eQMS Platform

35K+

Pages Processed Per Month

100%

Validation Pass Rate

Services

  • Word Processing & Formatting
  • Data Processing
  • Data Extraction

Platform

  • Client’s Proprietary e-Quality Management System
THE CLIENT

Cloud-Based Quality Management Platform for Life Sciences Companies

This mid-market SaaS provider sells a cloud-based eQMS (electronic Quality Management System) solution directed at regulated life-science teams (biotech, medical device manufacturers, and pharma). Their eQMS platform replaces shared drives, email approvals, and training spreadsheets with a centralized system that unifies compliance-driven documentation workflows. This solution combines document control, validation management, and audit readiness into a single interface, helping end users reduce manual effort, shorten time-to-market for quality-critical products, and maintain continuous inspection readiness.

PROJECT REQUIREMENTS

Document Processing Services & Formatting Support for eQMS Operations

The client required a dedicated operational partner to manage large-scale document processing within their eQMS platform. This need arose from a rapidly expanding customer base, leading to a surge in compliance-related documents.

They needed quick, accurate, and compliant support to ensure that every document was formatted correctly, validated, and ready for audit within the eQMS environment. The goal was to eliminate operational bottlenecks and maintain the platform's frontend performance without lag, regardless of document volume, while still producing compliance-ready reports of expected quality.

PROJECT CHALLENGES

Optimizing Document Processing at Scale with Zero-Defect Accuracy

  • High-Volume Throughput: The client needed continuous support to handle ~35,000 pages per month without quality drift or backlog buildup. Each document carried unique compliance and formatting requirements, demanding both speed and precision.
  • Inconsistent Document Layouts: Source files arrived in mixed formats (Word, PDF, scanned copies) with varying structures, making it difficult to standardize content for import into the eQMS platform’s templates without breaching the deadlines.
  • Scanned & Illegible Inputs: Many PDFs were direct scans or captured images of handwritten documents, requiring OCR for data extraction and manual verification of the extracted details before further formatting.
  • System Performance Bottlenecks: Large, table-heavy documents frequently caused the eQMS frontend to lag or freeze during processing, impacting submission timelines.
  • Smartlink & Symbol Management: Documents often contained foreign-language smartlinks, mismatched codes, and hard-to-locate symbols, slowing down formatting on the platform.
  • Compliance-Critical Accuracy: Given the life sciences domain, even minor Word processing & formatting or data-entry errors have grave repercussions, requiring zero-defect accuracy and consistent QA oversight.
PROJECT SOLUTION

Building a Scalable, Audit-Ready Document Processing Workflow

To address the client’s needs, we deployed a dedicated 14-member team that served as the operational backbone of their eQMS environment. Our human-in-the-loop data services combine domain expertise, advanced automation tools, and structured workflows to deliver speed, accuracy, and compliance at scale—ensuring every document we processed as a part of this project met stringent quality and audit-readiness standards. Task assignments and progress tracking were synchronized across the eQMS, Google Sheets, and the client team’s communication dashboard to ensure end-to-end visibility and accountability.

1

Structured Workflow within the eQMS Platform

The client shared initial documents and related details using a Google Sheet. We configured a systematic workflow within the platform to manage document intake, template selection, and submission. This enabled consistent monthly throughput of 35,000 pages without backlog or accuracy drift.

  • For each document, we recorded document type (SOP/validation/training), page count, due date, template to use, and any special instructions.
  • Verified file integrity (no password locks/corruption).
  • Classified files by format into editable DOCX, born-digital PDF, or scanned PDF/image.
  • Assigned non-editable files for OCR-based data extraction, and kept editable files in the document processing queue.
2

OCR-Based Data Capture & Standardization

For scanned, non-editable files, our team used ABBYY OCR tools for data extraction, followed by data standardization to align the extracted text with the eQMS platform’s structured input fields. This allowed uniform import of previously inconsistent layouts into standardized eQMS templates.

  • Ran OCR to convert scans into selectable text.
  • Exported the extracted text to a staging file and fixed obvious errors (e.g., “0/O”, “1/l”, broken hyphenations)
  • Assigned document sections with low confidence scores for expert review.
  • Normalized dates (e.g., YYYY-MM-DD), numbering, section headings, and units.
  • Applied consistent terminology (e.g., “SOP”, “URS”, “IQ/OQ/PQ”) as per the client’s style guide.
3

Created a Master Smartlink Sheet

Many regulated documents (like SOPs, protocols, or validation reports) referenced other documents (in English as well as other languages). For example - “Refer to SOP-1234 for equipment calibration,” “See Validation Plan VP-5678 for methodology,” or “Consulter la PROC-1234 pour l’étalonnage des équipements.”

To avoid inconsistencies during manual data entry from documents and PDFs, we created and maintained a master Smartlink sheet—a single source of truth containing each document’s official ID, name, and internal link, along with how it should appear in cross-references. When linking documents inside the eQMS, our team used this sheet to:

  • Insert the correct reference link every time (ensuring traceability).
  • Prevent broken or mismatched links.
  • Maintain consistent naming conventions across all documents.
4

Built a Library of Approved Symbols

In regulated life sciences documentation, certain symbols recur frequently, such as Δ (change), °C (temperature), μg (microgram), ± (tolerance), and so on. Instead of manually searching for these symbols in Word’s symbol menu or copying them from old documents, our team created a quick-access symbol library as a ready-to-use digital reference (like a cheat sheet or template toolbar).

When formatting Word documents or PDFs, we instantly copied and pasted the correct, pre-approved version of a symbol, ensuring:

  • Accurate representation (no visual glitches).
  • Consistency across thousands of documents.
  • Faster formatting turnaround and fewer symbol-related errors.
5

Data Entry into eQMS with Template Mapping

Once the text was standardized, we mapped each document to its corresponding regulatory template in the eQMS based on document type and compliance category. With the Smartlink sheet and symbol library integrated into daily document formatting workflows, reference errors and symbol mismatches were eliminated.

  • Identified the correct template (SOP, validation record, training document) as per metadata.
  • Ensured structured data entry into defined fields, like headings, tables, paragraphs, lists, and figures.
  • Applied reference IDs and hyperlinks using the master Smartlink sheet to ensure consistent navigation and traceability between documents.
6

Performed Digital Content Conversion

One of the challenges of this project was to make the documents within the eQMS platform easier to review, safer to approve, and fully compliant with both internal standards and external regulatory expectations. We ensured that through digital content conversion. This step also optimized frontend performance, preventing lag or timeouts when loading table-heavy documents inside the eQMS.

  • Applied consistent heading hierarchies (H1/H2/H3) and uniform spacing throughout.
  • Converted irregular bullets, mixed numbering, and indents into compliant formats.
  • Standardized captions, callouts, and compliance notices (“Notes,” “Cautions,” “Warnings”) as per the client’s audit style guide.
  • Ensured logical page breaks around tables and headings for readability and export consistency.
  • Verified that every document rendered correctly in preview mode with zero display or alignment issues.
7

Quality Validation via Three-Layer Review

Every document underwent a three-layer quality assurance before submission. This multi-stage data validation process ensured zero-defect delivery, upheld compliance standards, and built trust in every record entered into the client’s quality system.

  • Technical Validation: Checked metadata completeness, numbering, and field accuracy.
  • Peer Review: Independent review for symbol consistency, cross-references, and encoding integrity.
  • System Validation: Previewed documents inside the eQMS to confirm performance stability, no rendering lag, and a 100% validation pass rate.

Project Outcomes

By transforming high-volume document processing into a structured, audit-ready workflow, we helped this growing eQMS provider sustain performance under scale without sacrificing accuracy or speed. This outcome goes beyond faster turnaround – it shows how process discipline and automation with integrated human validation can preserve customer trust in data-driven systems.

Processed 35,000+ Pages Per Month

Ensured uninterrupted document readiness, keeping the client’s eQMS fully operational even during peak submission cycles.

Reduced Document Processing Time by 32%

Helped the client’s quality teams review and release documents faster and maintain regulatory submission timelines.

Achieved 100% Validation Pass Rate

Strengthened audit-readiness and eliminated the need to spend time on error correction or document revalidation.

Achieved 40% Faster Interface Load Time

Ensured smooth navigation and editing inside the eQMS, thus reducing user frustration and ensuring faster document processing.

SunTec has been a quiet but critical part of our success story. Their workflow design and QC discipline brought structure and reliability to an area that had been so chaotic. Now we rarely face any validation complaints from users.

- VP, Operations

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