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GxP Lifeline

Turning Document Review Findings Into Actionable Insights


In our last GxP Lifeline blog post, we introduced a significant opportunity for life sciences companies to increase visibility into the health of their quality management systems (QMS) by addressing document review procedures. The work document review teams perform consistently uncovers useful information on how efficient their quality systems are, but unfortunately there are two components holding most companies back from accessing and using their data:

  1. The first is providing document review templates for reviewers to report their outcomes on. Without standard templates, findings are scattered across all sorts of documents.
  2. The second challenge companies face is having a platform to collect and manage the outcomes of the reviews. Without a place to store all document review templates and findings, the collective outcomes are siloed and impossible to use for further analysis.

The Opportunity: Gaining Insights from the Outcomes of Document Reviews

For many, a lack of visibility into quality operations is a huge barrier to accomplishing goals. By addressing these two areas of document review procedures, organizations across the industry can create a powerful opportunity to significantly improve performance and the quality of products. If companies want to start making this opportunity a reality, they should provide their teams with document review templates that are designed for advanced analysis and an analytics-enabled platform where the templates and outcomes can be kept and managed.

There are two steps to achieving this goal:

Step 1: Creating Effective Document Review Templates for Advanced Analytics

The first step in leveraging the data from document reviews is making sure reviewers have a template they can report their findings on. Each document type (i.e., corrective action/preventive action, change control, batch record, etc.) should have a unique document review template for the appropriate person and/or review team to follow and use. This will standardize the way reviewers record their findings and ensures that the valuable information being uncovered is captured and organized.

A key ingredient and the secret to gaining more meaningful metrics from these reviews is building template questions that will produce actionable insights once advanced analytics are applied to the data. This means crafting questions in a way that will cover the desired quality system dimension(s) a team wants critical insights on. Based on our experience remediating Warning Letters, we recommend basing evaluations on the following crucial dimensions:

  • Quality assurance oversight.
  • Impact.
  • Effectiveness check.
  • Current good manufacturing practices (cGMP).
  • Practice.
  • Good documentation practices (GDP).

In addition to capturing these dimensions, we recommend creating questions that will produce a yes or no answer to avoid reviewer subjectivity, which is an additional benefit to using document review templates. Structuring them in this way assures that the information uncovered and recorded by reviewers will produce advanced insights into gaps and areas of improvement in quality management systems, once and if there is a platform where they are all stored.

Step 2: Deploying a Platform to Capture the Outcomes of Document Reviews

Standard document review templates that are built for advanced analysis are a major component to leveraging the outcomes of quality system document reviews, but that information is only useful if it is accessible. In addition to standard templates, there must be a centralized repository where they all reside in order to apply advanced analytics on the collected data. This does not necessarily mean creating a new system, but rather leveraging existing document management systems to enable the collection of document review data. By establishing a place where these outcomes can be collected, stored, and managed, teams can remove data silos and gain the access to apply 4.0 technologies like real-time analytics and artificial intelligence (AI) to better use the information.

Our recommendation is to collect the outcomes of the document reviews on a cloud-based platform because of the flexibility it offers. This approach increases accessibility and mobility, encouraging collaboration across teams, a benefit that has proven to be necessary in our new era of post-pandemic work. This allows reviewers to easily fill out the appropriate document review template and enables organizations to gain real-time insights and automatically communicate urgent or predicted issues and recommended corrective/preventive actions.

Valuable Insights from Document Review Findings

Designing effective document review templates and collecting the outcomes on a cloud-based platform is the ideal pairing to turn valuable quality data into actionable insights. If teams utilize these two components, they can standardize document review processes to increase data accessibility, and when paired with 4.0 technology, they will know which systems are compliant or at risk. They will also be able to identify which functional groups or employees need more training, where and how often errors are occurring, and much more in real-time. The path to Quality 4.0 can be simplified by adjusting current procedures to leverage information many companies already routinely collect. This is the perfect opportunity for the life sciences industry to increase visibility, make better data-driven decisions, and naturally shift to a proactive, collaborative quality culture.


Jaime Velez is the co-founder of Operations & Quality Systems Improvement Experts (OQSIE), a management and technical consulting company focused on supporting manufacturing, supply chain, and quality systems improvement initiatives at life sciences companies. Over the last 20 years he has supported more than 100 consulting engagements with life sciences companies, delivering significant productivity improvements. He started his consulting career at McKinsey & Company's Pharma Operations practice and has led major improvement initiatives with J&J, Teva, Novartis, Abbott, and Pfizer among others. He co-founded OQSIE in 2013. He holds a bachelor's degree in Industrial Engineering from Stanford University, where he was a three-time NCAA All-American water polo player.

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