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?
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.
Research by BaseX suggests that many companies do not have formal tools and processes in place for document review.
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:
So, how can effective document review processes prevent project disruption and reduce compliance risks?
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.
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.
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:
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.
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:
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.
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.
Blog post updated on 14/01/2025