Ultimate Guide to Document Management for Better Quality & Safety

Document Management Regulations

• FDA 21 CFR Part 11 has clear requirements for maintaining electronic records and documents with e-signatures. The primary goal of the regulation is to ensure the Regulatory Affairs (RA) team has the necessary tools to ensure the security of its documents.
• ISO 9001:2015 requires that organizations control the documents required by the quality management system. According to clause 7.5, records are a special type of document and must be controlled.
• The OSHA 300 Log for Work-Related Fatalities, Injuries, and Illnesses must be maintained by employers. Each entry on the log must be an OSHA 301 Incident Report form. OSHA also mandates documentation for other safety parameters, including certificates of hazard assessment and employee training, noise exposure measurement, periodic Lockout/Tagout (LOTO) inspections, and process hazard analyses (PHAs) for the life of the covered process, among others.

The Importance of a Document Management System in Quality and Safety

Documentation is regulatory compliance, as it is critical for sharing information, knowledge transfer, communication, and collaboration among key stakeholders. Managing all forms of communication, including emails, Word documents, PDFs, and image documents, and accessing them when required can be a very big challenge. Multiple versions may float around, creating confusion – delaying the process of making key decisions on time.

In safety management, incident reports, safety policies, risk registries, and other similar safety-related documents should be easily accessible for auditing and reporting purposes. For quality management, documentation was proof of how product changes throughout its lifecycle have an impact on design. Documentation-assisted design quality processes as living records help improve usability in the quality system.

An electronic approach to document management will create a central repository of documents related to training, incidents and near-misses, change, and design process. Businesses can leverage this new-age technology to create, modify, review, approve, store, organize, access, and share documents globally in a controlled manner. Using a robust document management system also allows quality and safety leaders to track each document from origin to obsolescence using in-built graphical dashboards, analytics, integrated collaboration, and workflow tools.

ComplianceQuest’s Document Management System is a cloud-based system built on the Salesforce Platform. It is designed to improve productivity and efficiency. The system aligns with various regulatory standards, including ISO 9001, OSHA, and GxP standards, to ensure the automation of the end-to-end document management workflow works seamlessly. With a workflow-driven process aided by secure digital capabilities, businesses can simplify the process of creating and updating documents, always ensuring the right templates are used. ComplianceQuest’s Document Management System can be used to

• Streamline the entire document review/approval process easily.
• Increase operational efficiency by improving access to the right version of information faster and more cost-effectively, regardless of platform.
• Gain access to the most current information, such as SOPs, policies, plans, work instructions, or manufacturing & production design.

Document Management is the First Step in Regulatory Compliance

Data security is a mandatory requirement per General Data Protection Regulation (GDPR). Although all document management systems have security, organizations need to ensure document security to protect business and individual interests. A company that cannot keep data protected can face several consequences, including -

• Loss of revenue due to a data breach as customers shift their business to a rival company.
• Impact on brand reputation having a long-term impact on the business.
• Loss of intellectual property, including documents related to strategies and blueprints can affect the business to lose their IP.
• Indirect costs, such as regulatory fines, litigation cost, the insurance premium can increase due to breach of data privacy.

ComplianceQuest draws on the strengths of Salesforce to provide its customers with a secure and reliable document management system. It aligns with standards such as ISO 9001, OSHA, and GxP standards to ensure the automation of the end-to-end document management workflow works seamlessly.

Best Practices of Document Management

A cloud-based Document Control System ensures that all the facilities always have access to the most recent set of approved procedures. While having access to the latest documents with all the version history is helpful, it is important to keep a few best practices in mind. Having these standardizations across the organization helps ensure all the personnel has access to the latest information and new operations are consistently onboarded.

Here are five best practices to ensure proper document management within the organization:

• Monitor access and permissions to documents that are used during the day, every day. Create and enforce strict policies to regulate authorized access to information and constantly update mechanisms for authenticating individual users.
• Check the status of backups and storage space in case of system glitches due to natural disasters or data breaches. Cloud backups should be constantly monitored to identify any limitations to storage space or policy updates in time so that your backups are not compromised.
• Regulate mobile access with security measures such as authentication, device registration, and data encryption to prevent unauthorized access.
• Encrypt storage of all documents with a layer of protection. In the case of a hybrid system, ensure that the documents stored in your hardware are encrypted.
• Conduct security audits periodically to avoid threats from hackers. Auditing security systems and assessing their capability helps protect them from malware.

Automation and Document Management

Paper-based document management systems restrict transparency and follow-up. There is no proper method to trace quality or safety incidents as everything is siloed. A document management system provides secure and permission-based access to records, inspections, and incident reports, thus improving sharing of relevant, safety-related information among departments and auditors. With a cloud-based document management system, businesses can share safety policies, plans, audit findings, permits-to-work, risk registries, and incident reports across different teams for collaboration and follow-up actions. 

In the quest to improve documentation, businesses are now focusing on automation. Automating document management improves access and enables standardization of safety processes across locations. Operators and workers at the site can use the information to understand better how to handle an emergency situation effectively.

ComplianceQuest Document Management Solution

CQ Document Management Solution enables managing the entire document lifecycle, gaining complete visibility, and relying on a single source of truth across all locations for more effective decision-making on health and safety-related issues. Support Your Entire Organization, including document owners, document creators, HR and training managers, IT/CIOs, Quality/EHS/ QHSE managers, and production/supply chain/operations teams.