The Importance of Document Review in New Product Development

Inadequate document review is often the root cause of failure in new product development and manufacturing processes. But what steps can organisations take to mitigate this risk?

What is document review, and why is it important?

Document review is the process of examining and verifying documents to ensure content accuracy and completeness. These reviews can be vital for preventing expensive business mistakes and monitoring the progress of projects in a company, but they are often a regulatory requirement, too.

Many companies are without a formal document review process

Research by BaseX suggests that many companies do not have formal tools and processes in place for document review.

What happens when documents are not reviewed effectively?

For any organisation, this can result in confusion, delays and error stacking. However, in companies delivering complex products and services, a lack of controlled document review can result in real commercial damage and revenue loss.

Teams operating without systematic oversight risk:

• Planning and resource allocation errors
• Misspecified designs
• Ignored change requests
• Delayed delivery
• Dissatisfied clients
• Poor quality outcomes
• Product returns and customer complaints

So, how can effective document review processes prevent project disruption and reduce compliance risks?

Effective document review procedures ensure:

1. Stakeholder agreement before taking critical actions

Formal workflows in a document management system ensure that drafts of key documents are reviewed and approved by relevant stakeholders before they are actioned. 

For those in high-tech industries (such as fabless semiconductor companies) where there are multimillion-dollar decisions at play - this kind of phase gating is necessary to prevent expensive mistakes and ensure the ongoing viability of projects. 

In the medical device world, they form part of the mandated design control process that ensures the iterative verification and validation of deliverables against requirements as projects progress.

The right digital tools can automate feedback collection, notifications, and approvals for groups of documents helping create ‘phase gates’ that ensure required levels of quality.

• Ensures product specifications exactly match clinical needs
• Continually validates deliverables against requirements
• Ensures accurate change control - to prevent the introduction of errors

2. SOPs can be checked regularly for accuracy

Standard operating procedures (SOPs) should undergo periodic reviews to remain aligned with best practices, regulatory updates, and real-world workflows.

Automated workflows in a digital document control process help organisations transform sporadic oversight into systematic review cycles.

Routine SOP reviews highlight discrepancies between written protocols and actual practices, allowing companies to ensure consistency in the way they work, while continually improving quality.

This process of procedural review is how the FDA ensures GxP (best practice) is maintained across the design, manufacturing and delivery phases of every life science project.

3. Controlled access to the latest document versions

Poor review practices are often caused by version control issues, as employees access, review and approve outdated or incorrect files.

A robust, digital document control system eliminates this "document anarchy" through automated workflows and versioning:

• Documents awaiting review and comments are clearly labelled/watermarked
• Obsolete versions cannot be mistakenly reviewed/approved for circulation

With automated document versioning, it is always clear what information teams should be reviewing and acting on, helping your business focus on project delivery rather than filing administration.

4. Readiness for regulatory audits and inspections

Regulatory and certification bodies around the world (such as ISO, the FDA and others) stress the importance of the regular review of quality documentation to achieve consistency in end products.

For those building solutions in the highly regulated medical device market, ISO 13485 and the FDA’s QSMR specify manufacturers must:

• Designate an individual responsible for reviewing and approving documents
• Ensure the availability of the documents established to meet the requirements
• Prevent the unintended use of obsolete documents
• Maintain records of changes to documents
• Reapprove whenever a document is changed

When you are audited, you need to demonstrate the way you comply with these requirements within a validated, documented Quality Management System.

While the quality standard ISO 9001:2015 does not talk about document review directly, it does require that organisations “control the documented information” within their quality systems. 

This includes being able to show your ISO 9001 auditor that you have organised your quality management system documents with the most ‘updated information available’ and have a system in place to ensure best practice is shared and understood.

Conclusion

Document review is a cornerstone of effective new product development and quality management systems. 

However, relying on paper systems or generic tools like Excel and Google Sheets can introduce unnecessary complexity and risk.

Finding a flexible and agile digital system that can set up sophisticated workflows to check and validate documents at critical times by exactly the right people should give you the competitive advantage you need. 

It should also help meet the requirements of the toughest regulatory regimes and demonstrate to auditors you have a robust system in place that effectively controls the risk of product failure.