Top 4 Reasons Why Documentation Reviews Are Critical to Compliance

Infrequent quality and compliance document review is a common problem for regulated organizations using a paper-based or partially electronic system. Even though these organizations may have internal policies that require them to regularly review their standard operating procedures (SOPs), work instructions and other critical quality documents, they often fail to track them down for revision, thereby violating their own policies.

A document control system must ensure that when a process changes, the actual process and the documented process are in sync. Often processes evolve without relevant documentation being updated to reflect the change. Documentation reviews are meant to ensure that documents are still applicable and accurate.

4 Reasons That Compliance Documentation Review Is Crucial

Regularly reviewing important documents will help you in your revision process because you will know immediately if something needs to be revised. This is far more efficient than waiting for something to happen that forces you to revise your document. Reviewing regularly allows you to become more proactive about change.

If your company is regulated and you can’t remember the last time your quality and compliance documents were reviewed, there are a few key reasons to do so sooner rather than later:

1. To update processes and instructions that have changed.
2. To ensure employees use the most current documents and follow accurate procedures.
3. To boost preparedness for audits and inspections.
4. To comply with FDA regulations, ISO standards, and other standards and regulations.

FDA regulations and ISO standards mandate that all companies manufacturing regulated products have a document change control system.

Per FDA 21 CFR PART 820, 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.

While ISO 9001:2015 requires that organizations control the documented information required by the quality management system (QMS), the standard allows an organization flexibility in the way it chooses to document its QMS, including when to document a quality management process, as long as it still achieves its overall objectives. (Note that ISO 13485:2016 states, “review and update as necessary and re-approve documents,” also leaving document review frequency to the discretion of the organization.)

Whereas some organizations may carry out annual document review procedures, others may review and revise their documents every two or three years because there were no changes during that time. As there isn’t a specifically mandated FDA 21 CFR Part 820 or ISO 9001 document review frequency, it typically depends on how often a document changes and how complex and important it is. Processes that change constantly might not need a formalized review date because each update already calls for a review.

How an Electronic System Offers “Built-In” Documentation Review

Companies that use a paper-based or hybrid document management system typically use a spreadsheet to track down documents, a process that is problematic because:

• It isn’t foolproof.
• It can be time-consuming.
• It is one of the common reasons document review falls through the cracks.

An electronic system can eliminate these obstacles by automating routine tasks such as scheduling reviews, designating reviewers, sending reminders and distributing documents. For example, MasterControl Documents™ provides built-in document review. It ensures audit- and inspection-readiness by tracking and maintaining all documents in a centralized, easily searchable location and provides a time-stamped audit trail, reporting and electronic signatures that are FDA 21 CFR Part 11 compliant.

In a paper-based system where employees check out documents manually, the process of routing, reviewing, revising and approving a document can be slow and inefficient. Tracking document activity can be difficult. For instance, a routed SOP may get misplaced or held up on a colleague’s messy desk for days or even weeks, meaning that searching for and retrieving the SOP might entail sorting through piles of paperwork.

An electronic system makes routing and tracking easier by:

• Automating document routing, follow-up, escalation, review, approval and storage, increasing the efficiency and effectiveness of document management.
• Providing a secure, centralized repository that simplifies search and retrieval.
• Ensuring SOPs and other quality and compliance documents will not go missing because the system will track the document at every step.

In a paper-based system where reviewing or revising documents often requires manually submitting change requests in person, the process of updating documents can be unnecessarily time-consuming and inefficient. In such cases, employees may even be using an obsolete or uncontrolled SOP that is in a nearby binder.

An electronic system makes it easier to update a document and maintain its accuracy by:

• Letting authorized users make revisions in a virtual collaboration space and providing a time-stamped audit trail that captures details of the revision.
• Enabling changes to be initiated and approved electronically, then tracked and made available in reports.
• Automatically archiving the prior version of the document upon approval and release of the revised version, ensuring that only the current, approved version of a document is available.

Additional ways an automated document management system can help enforce a company’s compliance document review policy include:

• Ability to add a review date to documents – If an SOP is scheduled for review on a certain date per policy, the system will notify stakeholders in advance to ensure the document is reviewed by that date. You can set the amount of time needed to review and revise the document prior to the review date.
• Ability to designate a role instead of a user for the document review task – Even when employees move on to different positions, departments or even companies, the role of document reviewer will remain, so the right person will always be notified and the task will not be forgotten.
• Visibility of the document review process to stakeholders – A system with robust analytics and reporting functions will let you generate reports to see which documents are due for review at a certain time (e.g., in 60 days, etc.) and you can then spread out your future review dates.

Controlling documented information is integral to meeting standard conformity and regulatory compliance requirements that require accuracy of quality procedures and documents. Document review must be a regular part of those efforts. An electronic system can do so without the inefficiencies of a manual, paper-based system.

Resources

“21 CFR Part 820, Sec. 820.40 Document Controls,” U.S. Food and Drug Administration, April 1, 2019 (Last revised).

“Guidance on the Requirements for Documented Information of ISO 9001:2015,” International Organization for Standardization.