EDITOR’S NOTE: This article is part of a series of highly popular blog posts that we are republishing to share their important topics with a wider audience and with those who may be new to GxP Lifeline.
Being in the regulated manufacturer arena, you have heard that oft recited phrase “if it isn’t documented, it didn’t happen.” This motto shared among life sciences companies means an efficient document control system is at the core of quality management. Documents and records serve as proof that your company follows good manufacturing and document management practices required for compliance.
SOPs, specifications, calibration instructions, procedures, packaging and storage instructions, test plans and validation checklists are just a few of the documents you create and use during a product’s development life cycle. When your product is on the market, you add in manufacturing production history records, change orders, complaints and corrective action reports.
Careful handling of large amounts of documentation is critical. According to U.S. Food and Drug Administration’s 21 CFR 820, document control refers to procedures for approval, distribution and change of documentation, and the designation of an individual or individuals authorized to implement those procedures.
Every controlled document must clearly state:
A documentation process that follows these guidelines meets the basic (checklist) standard of a document control system. After that, it’s common for companies to assemble their own structure and processes for managing documentation using paper-based, electronic or a combination of both types of tools to meet the requirements for compliance.
Employing a system that adheres to regulatory guidelines for the sake of being compliant can adversely impact your production timelines and time to market. The mechanics of making revisions, routing documents for approval and locating or redrafting lost documents are the biggest speed bumps in a product’s life cycle. Consider the following “hypothetical” scenario of a paper-based document control system.
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You’re walking through a manufacturing area with the company’s quality manager to see the document control system in action. You have randomly selected a procedural document that includes setup procedures, calibration parameters, acceptance criteria and work instructions. The document you are carrying is meticulously formatted, printed and neatly placed in a binder.
You arrive a workstation and see the same document. Right away you have a pretty good idea of how their document control system works, which seems to include saving money on paper and printing. The procedural document is an authorized photocopy bound with a large clip that’s straining to hold all the pages in place. The front page sports the document’s revision number and date scrawled underneath the previous revision that has been crossed out. There is a handwritten list of instructions where updated sections need to replace outdated sections. At the bottom of the front page, you spot a row of signatures, which you intuitively conclude are the autographs of the document’s approvers.
At another workstation, you see an older version of the same binder-clipped document only without update instructions. You surmise that the updated instructions haven’t arrived yet. You thumb through the document and see sections of content crossed out and notes accompanied by signatures scrawled in the margins.
It appears that a different person expedited the change process for this document. Instead of printing and routing the updated sections, this person streamlined the routing process by walking around to each stakeholder and waiting while each person manually entered and signed the revisions. Then, the same document was simply returned to the workstation. This makes you wonder how many times the document coordinator had to visit each stakeholder to get all the changes approved.
The next stop on your tour is a storage room that houses stacks of bins that serve as a document repository. Each bin reveals the type and status of the documents it stores. The document control staff tracks and locates all the documentation using printed spreadsheets attached to a clipboard. To retrieve a requested document, the staff members sift through the bins to find what they need.
While the previously described documentation “process” does abide by the regulatory guidelines, it’s not exactly the poster child of an efficient, scalable document control system. As a central part of the larger quality management picture, documentation has a big impact on the entire operation. When there is a data accuracy conflict, an approver is unavailable or a document gets lost, production delays occur. Once the updated documentation is approved, production personnel need to receive official training on the new procedures—not updated instructions to read in their spare time.
With so many moving parts, a paper-based document control system is prone to any number of errors and nonconformances. Many organizations are moving toward digital document control systems as a way to eliminate document-related violations and production setbacks.
In addition to avoiding routing delays and losing documents, a digital document control system enables multiple stakeholders to simultaneously review a document, reconcile conflicts and enter approval signatures from anywhere. A document control system that integrates with all other components of a quality system automates routing and distribution, sends reminders to stakeholders, and alerts the necessary personnel that new procedure training is required. Your document control system should speed up instead of stand in the way of getting product on the market.
David Jensen is a marketing communication specialist at MasterControl. He has been writing technical, marketing and public relations content in technology, professional development, business and regulated environments for more than two decades. He has a bachelor’s degree in communications from Weber State University and a master’s degree in professional communication from Westminster College.