Sandy Carson Hessen, Marketing Communications Manager, Pilgrim Quality Solutions
If you work in the Quality arena, you probably know that the effectiveness of a Quality Management System (QMS) relies extensively upon enterprise-wide collaboration and begins with a solid process for managing important documents, like standard operating procedures. But as rapidly as business and its processes evolve these days, many organizations struggle to stay current in a sea of change. So it’s not surprising that document management remains at the very top of quality management processes being automated within the highly regulated Life Sciences space.
Approximately 47% of companies surveyed by LNS Research last year indicated that they had adopted an electronic Document Management (eDM) system to enhance and expedite their quality processes. Clearly, there’s plenty of room for improvement in this area among industries where quality is key.
When the Stacks Start Piling Up
What is happening under those stockpiles of paperwork? Continual changes in products and processes are executed in an attempt to reduce costs, increase yield, improve product quality, lessen waste, and create more efficient production processes. Incessant changes and modifications, combined with industry regulations requiring document management, make it nearly impossible to maintain a structured, accurate quality management system without an automated process.
The lack of automation hampers users’ ability to find the right document at the right time, or to know the real-time status of documents. There may be several copies of the same document circulating throughout an organization at the same time, making changes and revisions hard to track and damaging document integrity. Accurate and current documents are hard to maintain without a centralized, automated database.
Further, compliance may be compromised without strict security measures. Paper-based systems make it difficult to trace who approved or revised the document, and cannot guarantee some changes will go undocumented. Ineffective document management may go unchecked, as there are no checks and balances systems in place, and inaccurate, unreliable documents could result, hindering the quality or safety of the final product.
Cut the Clutter and Make eDM a Staple
Paper-based and hybrid document management systems are unreliable and risky, but automated processes provide users with the ability to ensure that required steps have been completed, guaranteeing compliance, the safety of consumers, and the reputation of the manufacturer.
Automated systems are more easily maintained and are more compliant with organizational and industry regulations. Well-organized filing and archiving, the easy retrieval of data, comprehensive audit trails, and enhanced security measures contribute to increased enterprise-wide collaboration, effective management, and compliance.
Documents being revised should flow through a change control workflow to ensure that the changes being implemented are valid. System users should be able to easily navigate to the latest approved version, and readability should be a snap whether accessing the files on-site or through a mobile device.
An effective automated system will integrate document and change control procedures. It also will integrate with other solutions, providing access to approved, controlled documents in other areas of the quality system, including audits, CAPAs and employee training. In these cases, an automated system’s search and retrieval capabilities, dashboards, and repositories expedite the processes.
That’s a Wrap
Operational excellence and compliance are dependent upon accurate data and real-time document management. Although the change from paper-based or hybrid systems to a fully-automated system is a challenging one, recent regulations and scrutiny on product safety is making the transition necessary. Companies that use automated systems report quick return on investment through expedited and effective document control that drives overall enhanced conformance and harmonization of quality systems at the enterprise level.
SmartSolve® Document Management from Pilgrim Quality Solutions does just that. Pilgrim’s solution enables users to create, collaborate, approve, change, and train on documents in a single tool. It meets all electronic signature requirements outlined in 21 CFR Part 11, and those specified in Parts 820 (Medical Device) and 210-211 (Pharmaceuticals), and it allows companies to stay on track with processes designed to meet other FDA regulations.
Courtesy of Pilgrim Quality Solutions
Download this case study to learn how a medical device manufacturer saved $400,000 with SmartSolve Document Management
- Webinar — SmartSolve Document Management Showcase Discover how SmartSolve’s document management capabilities integrate document-based changes into the value chain, ensuring fast, secure access to approved documents and SOPs from any area of the organization, while meeting FDA, ISO and GMP guidelines.
- Video — A Controlled Document Lifecycle for Quality Management This 5-minute video examines the value of implementing an automated document control system for a cost-effective enterprise-wide management and compliance system.
- Case Study — Global Document Lifecycle Management: Structured Lifecycle and Change Order Management for Controlled Documents. Read how this Life Sciences company chose to implement an automated document management solution to replace its paper-based and semi-automated procedures among multiple sites.
- Product Data Sheet — Document Management Data Sheet