How to Build a Document Control Procedures Manual

How does your life sciences startup or scale-up manage its documentation?

Unfortunately, ineffective document management can result in serious disorganization, delays to market, compliance infractions, and penalties.

If your organization is struggling with document management, you’re not alone; thousands of growing medical device and pharmaceutical companies have serious problems when it comes to document control and management.

In most cases, investing in a results-driven quality management system (QMS) or document control system is the mission-critical first step that your life sciences organization should take in securing an effective document control and management process. Additionally, creating a clear document control procedures manual can position the organization for rapid and sustained document management success.

In this article, we’ll teach you how to build a document control procedures manual. We’ll also touch on why each step is critically important in ensuring increased quality, efficiency, compliance, risk mitigation, and more.

How to Build a Document Control Procedures Manual in 5 Steps

What is a document control procedures manual?

This type of manual serves as a single source of truth regarding your organization’s document control and management guidelines. It is where all document control procedures are stored, organized, and managed.

Following the document control procedures manual helps elevate your organization’s approach to document management and use. Additionally, it will help to improve internal efficiency by reducing the time spent searching for important documents.

Keep these benefits in mind as we outline the steps to build an effective document control procedures manual.

1. Create a Document Management Plan

Start by creating a document plan, organizing assets, and laying the basic foundation for your document control procedures manual.

Before you begin, think about the following questions:

  • Do you have templates for standard documents such as letters and invoices?
  • Do you have a content style guide?
  • Should new documents be dated or time-stamped?
  • What procedures are in place for sharing, reviewing, and approving documents?

By answering these questions, you’ll have a clear and accurate understanding of how your organization currently treats its documentation. From there, you can better identify any gaps in the document management process. 

2. Analyze Each Document

Next, identify the types of documents that your organization commonly uses. Take stock of your inventory of documents across all departments — including quality assurance

In most cases, standard documentation includes quality assurance documents, standard operating procedures, batch records, product specifications, log books, customer complaints, and more.

During this process, you may discover that more resources are needed to adequately analyze documents, organize, and store everything needed to prepare the manual.

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3. Establish Document Procedures and Requirements

After taking inventory, it’s time to start building document procedures and requirements.

Before you begin, answer the following questions:

  • How will documents be stored (centralized vs. decentralized)?
  • How will drafts be handled, reviewed, and approved?
  • Which systems will be used to create and manage documents?

During this phase, we recommend investing in a document management system. From file storage to document procurement, the right document management system can deliver significant value to your growing life sciences startup or scale-up. 

Additionally, most document management systems make it simple and easy to eliminate the unintentional misuse of documents by employees or other stakeholders.

4. Remove Unnecessary Documents

After establishing basic document procedures and requirements, remove all unnecessary or dated documentation. This will help to eliminate clutter and files that could potentially cause liability or risk of compliance infractions.

However, the archival process depends on the compliance and regulatory requirements that your organization must meet to preserve an audit trail. 

Unfortunately, failure to meet archival requirements could result in penalties or fines. As such, we recommend reviewing retention guidelines before archiving mission-critical documentation.

Automate with a Quality Management System

FDA requirements for quality management are modeled after ISO 9001. The ISO 9001 quality management system standard is based on seven principles, including customer focus, leadership, training, processes, continual improvement, decision-based evidence, and vendor relationship management. 

Finding and implementing the perfect quality management system is essential to building a document control procedures manual. Qualio not only simplifies document control but also amplifies your organization’s quality assurance impact.

If you’re in the market for a next-generation quality management system and don’t know where to start, we’ve created a free guide: 12 Questions to Ask Before You Buy an eQMS. Use this guide to find the best eQMS for your organization and learn the exact questions you should ask vendors before purchasing a solution.

At the end of the day, there’s nothing worse than overspending on an eQMS that doesn’t fit your unique needs. Read this guide to take the headache out of the purchase process altogether — supercharging your organization’s approach to quality management.

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Kelly Stanton

Director of Quality