Last year, the FDA released 476 warning letters. The total included 201 letters about violation of current good manufacturing practices (cGMP) such as document control. Regulatory bodies are focusing investigations on drug manufacturers, medical device manufacturers, and life sciences companies in the United States and international countries.
If your organization receives a warning letter, providing audit-ready documentation will be key to prove effective documentation and corrective actions and avoid further action. While it's possible to effectively document practices using manual paper-based methods, it's far more difficult compared to automated quality management solutions. A document control system can eliminate missing documentation, alert stakeholders to issues, and streamline corrective action processes (CAPA).
A document control system is among the most critical tools for compliance in highly regulated industries. Organizations at every stage of the lifecycle can benefit, from startups to organizations approaching approval for market. In this post, you'll learn the definition of a document control system, why it's needed, and the essential features to search out.
Learn more about the regulatory climate in Failure to Comply - Document Control in Highly Regulated Industries.
What is a Document Control System?
A document control system supports the management of files in compliance with regulations and quality management systems for documentation such as FDA, ISO, EudraLex, and others. Document control software systems support paperless process automation, the management of quality documents such as CAPA or non-conformance reporting, and audit trails.
Why You Need a Document Control System
If you’re researching document control systems for a highly regulated industry, there’s a strong chance that compliance is a primary concern. While reduced regulatory risk is a primary benefit of document control software (DCS), it’s far from the only positive outcome possible. The right solution can improve information security, increase transparency, reduce business continuity risks, and offer other benefits.
Benefit #1: Stronger Access Control
DCS can introduce strong, compliant identity and access management (IAM) practices in highly regulated industries to ensure only the right people have the proper access, at the right time. Without appropriate access governance, paper-based systems or ineffective paperless methods can introduce the risks of information leakage. In highly regulated industries, accidental data exposure could result in non-compliance, loss of competitive advantage, brand reputation damage, or other threats.
Eighty percent of information security professionals consider access control a top priority, according to a recent TripWire survey. By selecting a DCS which offers role-based access and custom controls, organizations are likely to unlock a data security advantage. Currently, 66 percent of organizations rely on manual methods to manage access and user identities.
Benefit #2: Improved Compliance
The right electronic solution for document control can simplify the process of complying with complex regulatory requirements for document management, including CFR Title 21, subpart 11 requirements for electronic signatures and passwords.
Poor document control systems are a frequent cause of warning letters from the FDA and other regulatory agencies. An effective software-based method of managing document quality can reduce the risks of incomplete documentation, incorrect forms with signatures, or spotty audit trails.
If your organization is seeking approval to bring a product to market or facing an audit, some of the compliance factors the FDA or other governing bodies will look for include:
- A complete revision history, including revision dates and the identities of editing parties.
- Complete document recall of outdated standard operating procedures (SOPs) and other irrelevant documents.
- Effective safeguards against unauthorized revisions, deletion, or alteration of records.
If your organization’s software or paper-based approach to document control doesn’t meet these standards, you could face regulatory risks.
Benefit #3: Transparency of Information
Document control systems should play an important role in identity and access management, by protecting sensitive documents from exposure to the wrong parties. They should also support simplified access when needed by allowing authorized parties to quickly search, find, and retrieve archived and active documents. Some of the ways a DCS should support transparency of information to the privileged user include:
- Storage for multiple document types, such as PDFs and spreadsheets
- Flexible, easy-to-use keyword-based search
- Access restriction based on user identity or role
- Comprehensive audit trails to monitor document views and edits
- Support for the retrieval of prior versions of documents which have been edited
- The ability to control the archival and deletion of outdated documents
- Mobile access to view, edit, and share documents
A DCS which offers an exceptional user experience (UX) for the transparency and control of information can prevent regulatory risks and lead to productivity gains. Compared to paper-based systems or less-effective software methods, the right technology can significantly enhance productivity. According to IDC research, knowledge workers who "manage, create, or edit documents" can waste up to 2.5 hours per day merely searching for information.
Benefit #4: Global Collaboration
In the past, paper-based approaches to document control systems required the exchange of documents by mail or fax machines. These heavily manual, slow processes could delay the review of documents significantly, which is a competitive disadvantage in highly regulated industries racing to market. Today, cloud-based software for DCS can enable real-time global collaboration between a distributed workforce with simple access from desktop computers or mobile devices.
Eighty-seven percent of leading organizations believe cloud-based approaches to collaboration represent a "true revolution in...effectiveness," according to a recent Forbes survey. According to the same study, 90 percent of leaders believe cloud-based cooperation has the potential to drive a more efficient, connected, and aligned workforce.
Benefit #5: Improved Quality Management
Quality management systems are a critical component of compliance and quality-driven culture in highly regulated industries. While quality management is a multi-faceted practice, document control plays a vital role in driving adherence with cGMP for SOPs, organizational policy, and other essential quality processes.
ISO standards, FDA cGMP and other regulations dictate the use of standardized systems for documentation change and review. If your organization is regulated by FDA or EudraLex or ISO certified, a document control system is a necessity. Beyond reducing risk, an effective paperless approach to DCS can increase efficiency with smarter processes for approval, document storage, and access.
Benefit #6: Disaster Recovery
The average cost of a single lost or stolen record is $225, according to Ponemon Institute research. If your organization falls prey to a cybersecurity attack or another disastrous event you could face the permanent loss or exposure of numerous sensitive documents. The average global cost of recovery from a data breach is $3.86 million. In highly regulated industries such as pharma or medical devices, the potential consequences of permanent information loss are immense.
Both legacy DCS software and paper-based approaches to the control of documents can present significant risks for effective business continuity. In contrast, cloud-based methods can offer distributed storage of documents off-site to ensure your organization can quickly recover from threats to data security.
Benefit #7: Business-Wide Streamlining
The leading software solutions for document control can offer extensive business benefits beyond smarter compliance, access, and security:
- The ability to quickly access and edit documents can support organizational agility
- Effective DCS and a quality-driven culture can improve company valuation
- Streamlined, centralized information access is likely to be a competitive advantage.
The right approach to document control can simplify processes for individuals at every level of the organization by offering streamlined workflows and transparency.
What to Look For in Document Control System Software
There are dozens of solutions and vendors in the marketplace which advertise a "document control system software." Some of the top search results you encounter are likely to include DCS designed for healthcare organizations, clinical trial applications, and knowledge management. Organizations in highly regulated industries such as pharmaceuticals, medical devices, or life sciences have no shortage of selection and highly specified requirements. To meet your company's needs for a compliant DCS, consider vendors who offer natural search, flexible document templates, regulatory compliance, and other key features.
Feature #1: Easy Search and Navigation
A key feature of document control system software is storage and archival. The software you choose should securely store your organization's critical documents in the cloud, and restrict access to privileged users. While secure storage is a critical component, many users neglect the importance of search and navigation. On a day-to-day basis, the user experience of internal stakeholders will be most impacted by how easy it is to perform keyword searches for the information they needed and the speed of retrieval.
A document management software should provide tools for organizing your data and searching based on user-defined criteria such as keyword or date. Prioritize vendors who allow you to attach metadata such as document type or date to files with tagging or customizable keyword fields.
Feature #2: Support for Multiple Document Types
If you narrow your search to DCS for highly regulated industries, you may encounter solutions which are designed for the control and management of standard operating procedures (SOPs). While these solutions can support the compliant management of one document type, they're not a comprehensive solution.
Consider all of the different types of documents your organization needs to manage in the present and future, and whether a solution offers appropriate support. Chances are, you need support for spreadsheets, XML files, PDF documents, word documents, and image files to capture documents such as training results, management review agendas, SOPs, CAPA, quality results, and more.
Feature #3: Compliance with CFR 21 Part 11
Title 21 Code of Federal Regulations Part 11 establishes FDA regulations for electronic records-keeping and electronic signatures for regulated organizations to create accurate documentation equivalent to paper records. These regulations apply, with some specific exceptions, to drug manufacturers, medical device manufacturers, biologics, biotech, and contract research organizations (CROs).
If your organization is currently subject to FDA requirements, seeking out a system which is fully compliant with Part 11 is critical. There are benefits to acquiring a compliant-system for companies in highly regulated industries who are in the earliest startup and scale-up phases of initial R&D also. Seeking out a compliant system can significantly narrow your search, and help your organization establish robust systems of complaint documentation from the beginning. It can also prevent the risks of having to replace well-established systems as you approach taking a product to market.
Feature #4: Learning Management Integration
Highly regulated industries face specific, steep regulatory requirements to educate employees on how to comply with all applicable regulations. These requirements could be met with the acquisition of a dedicated point solution for learning management which tracks employee training activities against requirements and automates learning activities. In the U.S., the pharmaceutical industry alone spends over $1 billion each year to meet learning requirements.
At large and well-established organizations, learning management may be managed in a home-grown system. Depending on your industry and applicable regulations, you may be required to provide training on environmental aspects, SOPs, cGMP, and other factors to employees which are compliant with guidelines for installation qualification, operational qualification, and performance qualification. These learning management systems generate a lot of documents and are required to comply with CFR 21 part 11.
Does your company need a learning management system which is the same as your system for document control?
Not necessarily, but it could be useful.
Regulatory requirements for employee training are continually evolving, and organizations need a learning management solution which can keep up with current recommendations for training. If your systems are separate, your learning management system needs to meet document control requirements for reports on employee training. There are significant benefits to document control and learning systems which offer either strong integration or an all-in-one solution, such as improved compliance, superior transparency, and convenience for employees.
Feature #5: Comprehensive Quality Management Systems
FDA requirements for quality management are modeled after the ISO 9001 Quality Management Standards. ISO 9001 Section 4 details the basic requirements for a total quality management system (QMS). These include:
- A quality management system for operational planning, document control, and record retention.
- Resource management to meet training regulations, certification, and equipment management standards.
- Product realization components for customer requirements, advanced quality planning, process validation, and more.
- Measurement, analysis, and improvement through the control of customer satisfaction, audits, process monitoring, and quality improvement.
- Management involvement via quality policy, planning, and formal review.
According to the same standards, the system for QMS must create "value," which is defined as results. While a DCS is just one component of the total QMS vision outlined by ISO 9001, it's a critical component. Your organization must use a document control system to prepare for certification or audit to prove aspects such as operational planning, training, monitoring, and management review.
Even if your organization is not currently subject to ISO or FDA requirements for CAPA, there are benefits to selecting a document control system software which can scale to comprehensive quality management with features for training, monitoring, review, and other attributes. Compliant, flexible systems can enable your organization to grow and scale seamlessly without having to make a disruptive switch.
Document Control Systems Aren't Just A Regulatory Requirement
Organizations in every industry can benefit significantly from standardized, cloud-based software solutions for managing documents. Organizations in pharma, medical devices, or life-sciences need a document control solution to meet regulatory requirements for documentation, audit trails, and other compliance factors. If your organization needs an FDA-compliant solution for managing documentation, identifying a vendor whose software fully complies with CFR 21 Part 11 is crucial.
Compliance is far from the only potential benefit of DCS software, however. For highly regulated startups and scale-ups, the right DCS can offer a baseline for compliant operations and workflows and the ability to scale. By fully understanding the business benefits of the right document control systems and the most important features to look for, you can implement a solution which scales with your organization's needs.