Reevaluating Paper-Based CQV: Why Clinging to Tradition Increases Risk

Binders feel safe. But in commissioning, qualification, and validation (CQV), they create context gaps, transcription errors, slow retrieval, and audit pressure when regulators, inspectors, or QA reviewers demand end-to-end traceability. The solution isn’t more paper. A digital, risk-based CQV flow builds traceability, review-by-exception, audit trails, and e-signatures so you reduce rework and accelerate release.

What Paper Costs in Time and Audits

Paper-based CQV feels controlled because the records are tangible.  But physical binders, manual transcriptions, print-sign-scan loops, and scanned PDFs create data-integrity gaps: incomplete audit trails, version drift, and slow retrieval. Regulators expect manufacturers to design data governance that protects integrity across the lifecycle. The format does not change that responsibility — and paper offers no exception.  

Paper workflows make it harder to meet ALCOA+ expectations and to demonstrate trustworthy electronic records and signatures when you digitalize downstream. 21 CFR Part 11 sets criteria for making electronic records as trustworthy as paper and requires controls for creation, modification, and retrieval. These controls are exactly where paper-hybrid processes tend to fail.  

In CQV, equipment validation is only effective when evidence and decisions are traceable end-to-end.

What Do Regulators Expect?

Across regions, expectations converge on risk-based assurance and digital controls by design. EU-GMP Annex 11 points to access controls, audit trails, and data integrity for computerized systems; Annex 15 emphasizes fit-for-purpose qualification and validation across facilities, utilities, equipment, and processes. 21 CFR Part 11 sets criteria for trustworthy e-records and e-signatures, including controls for creation, modification, and retrieval. ICH Q9(R1) strengthens decision quality and communication so testing scales to risk and intended use rather than document volume.  

The goal is confidence by design, not more paperwork. A digital, risk-based CQV flow links requirement to test-to evidence to release in one place, with role-based access, time-stamped audit trails, linked e-signatures, and version/change control that protect ALCOA+. You focus on risk, capture evidence at the point of work, review by exception, and retrieve end-to-end traceability in minutes — no binder hunts.

Specific terms like CQV or IQ, OQ, and PQ matter less than the outcome. Here is how to put that into practice:

1. Start with intended use and risk.
   
   
2. Use supplier assessment and commissioning evidence where it is sufficient.
   
   
3. Add installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) where risk warrants it.
   
   
4.  Choose scripted, unscripted, or automated testing based on risk and intended use, consistent with computer software assurance (CSA) principles. Record rationale and results in the same system, so traceability is automatic.  
   
   The result is fewer documents and stronger, inspection-ready evidence, enabling review-by-exception, faster quality assurance (QA) release, and compliant change control across the lifecycle.
   

A Simple Control Map Built into the Digital Flow

In a validated, digital environment, essential controls are built into daily work. You enforce role-based access with unique, attributable user IDs and map permissions to tasks. You maintain time-stamped, immutable audit trails to create, modify, and delete records, and review them on a defined schedule per standard operating procedures (SOPs). Approvals use linked e-signatures that capture identity and intent, and change control provides impact assessment and approvals with periodic review. Linked protocol templates (for equipment validation) standardize content and enable reuse. Together, these controls align with the intent of Part 11 and Annex 11 and keep ALCOA+ in focus while making the record itself inspection-ready.

Why Paper-Based CQV Raises Risk and Slows You Down

Paper feels tangible, but in CQV it creates failure points that surface during inspections and delay product release to distribution. The three patterns seen most often are: 

1. Fragmented rationale: Paper scattered across systems makes it difficult to show why specific risks were tested and why that level of testing was sufficient. This creates a gap when decision-making and communication are not clearly documented or traceable. As a result, reviewers cannot reconstruct the logic, and inspectors may judge the rationale as incomplete.
   
   
2. Transcription and paper-on-glass: Manual copying, re‑keying, and printing‑to‑scan introduce discrepancies. Scanned PDFs break traceability from requirement to evidence and redlines can obscure the true sequence of changes. A digital flow captures data at the point of work, links it to the requirement, and preserves the who, what and when for each change.
    
3. Retrieval delays: Hunting for a single signed page across binders or across multiple shared drives slows investigations and audits. Teams spend hours reconstructing the trail instead of addressing issues. With structured, searchable records, the system can retrieve requirement to test to evidence to approval in minutes.

Across pharma, biotech, and CDMOs, moving CQV into a digital, risk-based flow consistently shortens cycle time and eases inspections.

What drives the gains?

• Traceability on demand: When requirements, scope, executed evidence, and approvals are linked, you can retrieve the end-to-end story in minutes instead of reconstructing it from multiple repositories. That makes investigations faster and inspection time predictable.
  
  
• Review-by-exception: QA effort shifts from paging through documents to focusing on flagged exceptions and risk-relevant steps, reducing rework and hand-offs.
  
  
• Standardized content and reuse: Approved templates for protocols reduce variability across products, lines, and sites, and accelerate change control.
  
  
• Fewer transcription errors: Data is captured at the point of work with attributable user IDs and time stamps.
  
  
• Integrated quality and manufacturing: Interfaces with manufacturing execution systems (MES), enterprise resource planning (ERP), and quality management systems (QMS) to eliminate duplicate entry, align master data, and surface issues earlier in the process.
  

What does this mean for CQV leaders?

Digital CQV works not because there is more documentation, but because assurance is built into daily work: risk determines test depth, content is reusable, and evidence is tied to intent. The result is stronger, inspection-ready records and shorter paths to product release.

Start Here — A 90-Day Pattern

Weeks 1 to 2: Align on intended use and risk. Identify the systems and processes with the highest compliance exposure or cycle-time impact. Record intended use, risks, and acceptance criteria once in the validation workspace. Prioritize critical utilities and rooms so cleanroom qualification and validation are executed with exception-based quality review 

Weeks 3 to 6: Build a small library of approved content. Standardize reusable requirements, test intents, and acceptance notes; include protocol templates. Apply CSA principles to select scripted, unscripted, or exploratory testing based on risk and intended use. 

Weeks 7 to 10: Execute with guidance; review by exception. Capture evidence at the point of work, auto-flag out-of-range entries, and route for attributable e-signatures; generate summaries and traceability from the record. 

Execute monthly records-retrieval checks: Practice pulling requirement-to-evidence traceability by product, lot, or change so your team can answer inspection questions in minutes, not weeks.

Figure 1: A retrieval drill shortens CQV timelines by aligning on risk, building reusable content, and streamlining execution with digital workflows.

Digital Validation Maturity — From Manual to Digitalization to AI

Digital validation maturity progresses in clear steps. You move from paper and scans to a validated e-records system with role-based access, attributable e-signatures, and immutable audit trails. Next, you standardize content and templates so rationale and evidence stay together, and QA can review by exception. You then integrate with a QMS, MES, and ERP to reduce duplicate entry and surface issues earlier.

With CSA principles, the level of testing matches the risk and intended use — scripted, unscripted, or automated as appropriate. Once these foundations are in place, you may add AI assistance under governance: define context and limits, verify outputs, record expert approval with attributable e-signatures, manage changes under change control, and monitor performance.

Figure 2: The digital validation pathway: paper to digital to governed AI.

From Binders to Built-In Assurance: The Takeaway

Paper is familiar, but it raises risk where it matters most: decision clarity, traceability, and timely retrieval. Regulators expect risk-based assurance designed into validation and release — not more documentation. By moving CQV into a validated digital flow, controls are embedded where work occurs, including immutable audit trails, attributable e-signatures, role-based access, and change control that upholds ALCOA+. 

For CQV teams, the path is realistic: standardize content once, map permissions to tasks, and automate traceability from requirement to evidence to approval.  

The outcome is measurable — faster release cycles, fewer inspection findings, and inspection-ready records you can defend on demand, in minutes rather than days.

Want to learn more? Watch our on-demand webinar to see how leading pharma companies are transforming equipment validation and qualification with digital solutions.

Sources:

EU-GMP Annex 11: Computerized Systems. European Commission (2011). Official PDF.  

EU-GMP Annex 15: Qualification and Validation. European Commission (2015). Official PDF.  

21 CFR Part 11 — Electronic Records; Electronic Signatures. eCFR.  

ICH Q9(R1) — Quality Risk Management. Final Step 4 (Jan 2023). ICH Database 

ASTM E2500-25 — Standard Guide for Specification, Design, and Verification… (latest edition page).  

FDA Draft Guidance — Computer Software Assurance (CSA) for Production and Quality System Software (2022).  

PIC/S PI 041-1 — Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (July 2021).  

ISPE GAMP® Guide: Artificial Intelligence (guide landing) + TOC (proof of scope).  

FDA Draft Guidance (Jan 2025) — Considerations for the Use of AI to Support Regulatory Decision-Making for Drug and Biological Products (landing + PDF + Federal Register).