What is Document Controls?

The Document Control process involves the management of documents in terms of creation, review, approval, distribution, and archiving that result in maintaining accuracy and compliance in the documentation. Document Controls are important because without effective Document Controls you have:

• High Probability of Errors: An error in even one document that goes unnoticed can quickly proliferate throughout an organization and lead to poor decision making
• Security Weaknesses: Documents can contain highly sensitive information that can be easily leaked or hacked and this can cause major reputational and regulatory damages
• Operational Efficiency: Even with a document controls process in place, the amount of documents to monitor can grow very quickly and it can be cumbersome to manage this process without the proper tools
• Regulatory Risk: Regulations like CFR Part 11 outlines specific requirements for document controls which if not followed can lead to major fines and other penalties

What is the Regulatory Landscape around Document Controls?

Due to their importance, Document Controls are subject to various regulatory requirements. Some of the key regulations surrounding Document Controls include:

• 21 CFR Part 11: This regulation from the FDA outlines that documents must have proper controls, be secure, and electronic signatures that are trustworthy
• EU Annex 11: This regulation also provides guidance on the use of electronic systems, but primarily in Europe and outlines recommendations for Validation, Audit Trails, Data Integrity, etc
• NIH Harmonized GMP Requirements: The NIH from the United States has released this guidance on Documents and Records that outlines how to effectively conduct audits and maintain quality when creating documents
• ISO 9001: This international standard for quality management also emphasizes the importance of Document Controls across all industries

How to implement Document Controls?

So, how do you actually implement effective Document Controls, avoid regulatory penalties, as well as mitigate the other risks that come from poor Document Controls? Not to worry: there are several Best Practices that can help you manage your documents effectively:

• Document Approval Workflow: Having a well defined approval workflow creates accountability for the quality of documentation and helps distribute responsibility effectively, making maintaining high standards for quality possible. Automating and monitoring this approval process through roles, permissions, and alerts can make these approval workflows a lot easier to implement and sustain.
• Assess Control & Audit Trail: Only the right people should have access to the right documents. Assess Control helps make sure that this is the case with added security and Audit Trails that track who is making what changes to a document can help understand where errors or data leaks are coming from and mitigate these problems.
• Protect Documents with Sensitive Information: Securely locking files that contain sensitive patient data or information about new pharmaceutical drugs is critical as these documents have a particularly high risk of resulting in reputational and regulatory penalties if leaked.
• Configurable Electronic Signatures: Trustworth electronic signatures are a requirement specifically called out by many regulations. This improves transparency and provides the proper legal framework to document when proper procedures are being followed.
• Password Management: Even with password protected security measures in place, poor or aging passwords still provide a high security risk of failing to mitigate bad actors from engaging in malicious activities.

CIMCON Software

CIMCON Software has been helping hundreds of clients with compliance of pharmaceutical regulations like CFR Part 11 for over 25 years. Through our experience, we have perfected controls that provide the functionality we recommend above to keep your documents secure and mitigate the risks discussed in this article. That is why we count 8 out of the Top 10 life science companies as our customers. With offices in the US, UK and Asia-Pacific, 500 customers in 30 countries, 24/7 support, and partnerships with multiple Cloud and technology vendors as well as Value-Added Resellers across the globe, CIMCON can support your implementation at a single site or across the enterprise.

The Power of Documented Controls

Overall, Document Controls can be hard, tedious, and difficult to maintain without errors. However, doing so is incredibly important as without proper document controls, firms can face major operational burdens, high levels of security vulnerability, poor business decision making, and strict regulatory penalties. But there are time tested strategies and tools that can help mitigate these risks without breaking the bank or having all team members work overtime and these can help propel your organizations digital transformation.