Featured Use Case: How Adlib is Automating Controlled Document Assembly & Validation in Pharma Manufacturing

“Paper trail”, in pharma manufacturing, isn’t a turn of a phrase. Paper trail is a compliance mandate. It’s a proof of control. It’s the system.

Standard Operating Procedures (SOPs), batch records, cleaning logs are the building blocks of an effective and GxP compliant operations. These are often printed, signed, and distributed across the plant floor as controlled documents. And while these documents are essential for GxP compliance, they can just as easily become a compliance liability.

Here’s the problem: paper doesn’t update itself.

Organizations spend millions building validated processes, only to risk it all when an outdated SOP stays in circulation because someone pulled the wrong version from a shelf or binder.

In fact, one of the most common reasons for FDA Form 483 observations is failure to maintain up-to-date procedures and ensure only the latest versions are in use, cited under 21 CFR 211.100 and 211.22(d). This one issue has been responsible for delays, warning letters, and even production shutdowns.

So, how do you ensure every controlled document in your facility is assembled right every time and is the right version, without chasing binders or relying on tribal knowledge? Scroll for details.

The Challenge: Time-Consuming & Error-Prone Controlled Document Prep & Validation Process

Despite the rise of modern QMS platforms, assembling controlled documents remains a painfully manual, fragmented process for many pharma manufacturers.

It often looks like this:

1. Documents are pulled from multiple systems: DMS, QMS, shared drives, even email.
2. Staff manually format each page, adding headers, footers, tables of contents, and watermarks.
3. Reviews are done (and redone) to ensure accuracy before printing.

Once a document is printed and signed, it leaves the digital safety net of your QMS. It gets taped to walls, passed between shifts, and occasionally forgotten in a drawer. When a revision happens, that paper version doesn’t vanish, it lingers. And if someone unknowingly follows an outdated procedure?

That’s a compliance event waiting to happen.

Manual roundups of old documents are time-consuming, error-prone, and just not scalable. What pharma companies need is a way to bring real-time visibility and control to every printed page automatically.

The Solution: Full-Stack Automation for Controlled Document Confidence

Adlib flips this broken process on its head with end-to-end automation that assembles, validates, renders, and tracks every controlled document automatically.

No more manual formatting, copy/paste gymnastics, or compliance gray areas.

Here’s what Adlib delivers:

1. Automated Document Assembly
Adlib automatically pulls documents from multiple sources (QMS, PLM, ERP, file shares) and merges SOPs, procedures, specs, and forms based on predefined logic. To ensure compliance with industry standards, Adlib applies formatting rules (headers, footers, watermarks, TOCs, and bookmarks), all with zero user intervention.

2. Validation & Compliance Built In
Adlib ensures metadata and version information are accurate and embedded, then applies watermarking, PDF/A rendering, and digital signatures, eliminating inconsistencies that trigger audit flags.

3. Data-Driven Output
Adlib prepares content for LLMs and extracts key fields into structured formats (JSON, XML), integrating directly with LOB systems for analytics, dashboards, or AI processing. This step is critical for fueling downstream automation and insights with vectorized, AI- and Automation-ready structured data formats.

4. Routing For Review
Adlib automatically validates the document for necessary signatures and stamps, classifies by controlled document type, and routes the document to the appropriate department for final approvals.

‍5. Optional Version Validation
Adlib adds dynamic QR codes so employees can verify the document's status on the fly, telling you instantly if the copy is valid, expired, or has been replaced (see more details about that below).

This process runs at enterprise scale, across thousands of pages and hundreds of controlled documents, without requiring additional staff or re-validation of your tech stack. We slot into your system, render documents with precision, and provide version control confidence that’s actually audit-ready.

Smart Controlled Documents For Smoother Compliance

Adlib introduces a no-touch, zero-hassle solution: auto-generated QR codes embedded into every controlled document at the time of rendering (or printing).

This QR code is your live link to your system of truth.

When an employee scans the code using any device, the status of the document is instantly verified by linking directly into your QMS system:

✅ Still valid
❌ Obsolete – please destroy

This validation process happens on demand, in real time, and without a single extra step for your team. No more walking the floor to chase down outdated documents.

The Outcome: No Loose Ends, No Loose Documents

With Adlib, every controlled document is born complete, validated, and compliant:

• No formatting gaps that violate SOP formatting policies
• No data inconsistencies that trip up batch record reviews
• No expired documents floating around the plant
• No guessing, no manual rework, no last-minute scrambles during inspections

You save time but also eliminate downstream risk.

Pharma Compliance Is a Game of Precision. We Help You Win It.

According to FDA data and industry analysis, nearly 30% of pharmaceutical Form 483 citations are tied to documentation issues, including outdated SOPs, incorrect formatting, missing approvals, and lack of access to current procedures.

This oversight is one of the biggest compliance risks in modern pharma manufacturing.

Adlib helps you eliminate that risk entirely, before regulators even step on-site.

Let’s recap what Adlib brings to the table:

• End-to-end automation of document assembly, formatting, enrichment, and validation‍
• Compliant-by-design PDFs with metadata, digital signatures, and formatting rules applied‍
• Reduction in compliance incidents tied to outdated, misformatted, or incomplete documents‍
• Real-time lifecycle management that scales effortlessly across plants and global teams‍
• Structured outputs ready for audit logs, analytics platforms, and AI automation

Adlib is not a document formatting tool. It’s your compliance safety net, automation engine, and trust anchor, all in one.

Ready to lock down controlled document compliance for good?
Let’s talk.