Highly regulated industries like biomedical engineering, life science, and pharmaceutical development are always at risk of an audit by a regulatory agency like the United States Food and Drug Administration (FDA). The last thing you want to worry about is the FDA or related regulatory body finding an issue with your compliance with regulations. Documentation, moreover, detailed, accurate documentation is critical to avoid these pitfalls common to these industries.
Keeping an organized and updated system that keeps your documents in order and ready when you need them can be challenging. This is especially true if you are a small startup and perhaps lack the capability to keep regulatory documentation paperless. Most of all, keeping these documents in order while also adhering to regulations with stellar compliance is a massive concern.
That’s why an effective document control system can make all the difference.
The best way to reduce a risk of an audit or inspection by a regulatory agency is to obtain a consultation by a regulatory expert to ensure that you are doing everything correctly.
What is the Document Control System?
A document control system allows for easy arrangement and organization of files that comply with the quality assurance and regulatory standards set by governing bodies like the FDA. An effective document control system will typically be paperless, and their graphical user interface should make navigation and reporting compliance easy.
Document control signals to regulatory bodies that your group follows good practice in the manufacturing and management of products. It assures that your group can access all documentation and track changes made to crucial compliance in standard operating procedures.
Types of Documents Required for Creating Regulated Products
Clinical trials, for example, have massive documentation needs as they produce a lot of case report forms (CRFs) as well as protocol management copy that must be organized properly for the FDA and sponsors. Things like standard operating procedures (SOPs), CRFs, investigational review board (IRB) correspondence, plans and reports, checklists, adverse event logging, and protocol deviations all need to be handled carefully, and this can be challenging.
Document control involves tracking different information related to the document, like the name of the person who created it, who approved the document, its status (valid, draft, in revision, awaiting approval), and authorization status (controlled/registered copy or authorized printout with signatures). Controlling for this information is usually a standard requirement for reporting to most agencies. With so many moving parts, a paper-based document control system is prone to errors and thus, nonconformances. A digitized document control system can eliminate these errors if implemented consistently across the organization.
Related: Ways to Collect Clinical Data
Document Control Is Not Just About Checking Boxes
The process of documenting information, and keeping that documentation controlled, is not just a system of checking boxes. While running through a basic checklist is how you meet minimum standards, you need to think about how best to organize things in relation to your company’s needs and structure. Document control is not a one size fits all process, and tailoring the process to your individual pipeline is critical for success.
For example, hybrid paper and paperless models of document control technically meet minimum requirements for most agencies. However, doing so can hurt your company if it is not employed properly. Mismatched information between electronic forms and hard copies are common in this model and can spell disaster for the life cycle of your product.
Related: Mythical Medical and The Unsolvable Equation: Benefit-to-risk analyses
Why You Need a Document Control System
If you are in the market for a better document control system than the one you are currently using (if you have one, at all), there are a few things you need to consider. Compliance will always be a primary concern. A good document control system will not only reduce the regulatory risks of compliance, but also increase transparency, improve security, and reduce the dissonance between hard copies of documents. There are other potential benefits.
Better Access Control
With electronic documentation controls, you can set user permissions. This ensures that only the correct people have access to the right documents. Say, for instance, you are an administrator, and you only want to share documents with either other admins like yourself or approvers. A quality document control system will allow you to do this, share and distribute and modify relevant documents without looping in the wrong team members.
Improve Compliance
Electronic document control simplifies meeting compliance, and a particularly great control system will make obtaining authorization signatures or sharing passwords securely a breeze. These systems will minimize the risks of incomplete authorizations, incorrect forms, or drop-off in the audit process.
Learn ways that you can improve compliance with our services and solutions.
Transparency
Document control systems allow for seamless access to documents needed across many teams within your company. Increasing transparency improves data flow and prevents chokes in the pipeline of your product or service. When your team is taking too long to retrieve archived documents, you have an issue, especially during an audit or inspection. A good document control system will be able to handle many different file types, possess an accessible keyword query system, and control and modify user permissions accordingly.
Global Collaboration
If your workforce is spread across many different facilities over the nation, or even the world, a cloud-based electronic document control system will improve the speed at which collaboration can happen. A common holdup for large operations is the slow courier system across these office locations; electronic documentation controls eliminate this lag.
Enhance Quality Management
Document control will make modifications to quality assurance protocols like SOPs, as well as updating in accordance with quality control testing far faster. It also ensures adherence to regulations and internal company procedures.
Create a Document Control Governance Board
A best practice would be to create a cross-functional document control governance board. It would include those within quality systems, information technology, and process owners. Their collaboration facilitates creating, implementing, monitoring, and adjusting the infrastructure. They can take a risk-based approach as they actively oversee and evaluate the current state and then develop strategies for improvement and growth as business needs change. Finally, the board and create metrics and present to important internal cross-functional stakeholders (reviewers, approvers, process owners) and senior leaders.
Recover from Disaster
When problems arise, such as a data breach, cloud-based document control systems can ensure your group will be able to land on its feet. Losing data can be disastrous for many business sectors, but good control systems can mitigate this risk effectively.
Related: Metrics for Notified Bodies, Manufacturers, and Regulators
Bottom Line
Document controls are some of the most crucial components of running a company in a highly regulated field. The tools you need to adhere to compliance standards while also maintaining the flow of operations can be accessed through these document control systems.
Having trouble with the compliance standards? Contact us today for more information!