The all-too-common scenario of businesses using homegrown and paper-based systems to manage quality and regulatory documents and documentation requirements creates inefficiencies and unnecessary costs. However, it presents even greater risks for organizations in Life Sciences, Aerospace and Defense, and Automotive, where stringent quality management and sustained regulatory compliance aren’t just nice-to-haves—they’re a critical part of doing business.
As a result, many software vendors have come to market in recent years offering more targeted document management solutions to help businesses in these sectors manage and control quality regulatory compliance documents within a centralized, online repository.
In this article you’ll learn more about the drivers compelling manufacturers to implement document management solutions, the types of document management solutions providers that deal with quality and regulatory content, and what you need to know when evaluating solutions.
The Failure of Paper and Homegrown Systems
It’s becoming increasingly impossible to use traditional means to manage quality and regulatory documentation, especially for highly regulated manufacturers. Archaic paper-based approaches, manual processes, and disparate systems cultivate vast inefficiencies as organizations struggle to use the right document versions, stay up to date with changing regulatory requirements, streamline document review and approval processes, and ultimately achieve Operational Excellence through optimizing document management processes.
The culmination of these combined inefficiencies manifests in wasted time associated with manual processes, redundancies as a result of poor communication and collaboration, and soaring costs. It’s also a matter of the risk presented by not ensuring complete, sustained compliance with regulatory requirements, 100 percent of the time.
But above and beyond the disadvantages of using traditional, manual systems, industries in these highly regulated industries are seeing the particular advantages of leveraging streamlined document management solutions. These include:
- Compliance Assurance: Many quality and regulatory document management solutions providers either directly provide or link to third-party, up-to-date compliance content to ensure their software is current with all regulatory requirements—requirements that have details that evolve and shift on an ongoing basis. Given the importance of continuous adherence to regulatory requirements in these highly scrutinized sectors, it’s important to stay on top of the game if not ahead of the curve at all times.
- Version Control: A key problem with paper-based, manual systems is that physical, printed documents simply can’t keep pace with their centralized, electronic counterparts. Manufacturers need to have easy-to-access, current versions of all relevant documentation, and they need to be able to access it with comparative ease. Most document management software vendors grasp this and attempt to provide seamless access to the most current versions of documents—a must have, from a regulatory perspective.
- Paper Costs: The per-unit costs of paper seem marginal, but on the level medium and enterprise manufacturers use paper, the associated costs of paper use appear in orders of magnitude above per-unit costs. So beyond all the substantial efficiencies achieved through document management solutions, another key driver is the sheer costs associated with achieving a ‘paperless manufacturing environment.’ Fewer skids of 8.5”x11” monthly goes a long way in the long run from a bottom-line perspective and we have seen examples of companies saving hundreds of thousands of dollars annually by eliminating paper-based systems from the shop-floor.
- Aging Workforce and New Demographics: It’s an issue all manufacturers either are contending with currently or will have to deal with in the coming months and years: the relief of a venerated workforce in the face of younger, more tech-savvy new hires. As we’ve alluded often in this blog, the new workforce has tech in its veins and is far more predisposed to use streamlined, web-based tools than it is to use paper-based systems. To facilitate not just user adoption but also employee engagement organizations have to leverage web-based document management tools to engage and retain top talent.
The Different Types of Quality/Regulatory Document Management Vendors
A number of streamlined document management solution providers have arisen and we’ve identify two different types of vendors in this space:
- Third-party vendors building on existing platforms: These are purpose-built systems that have been developed with quality and regulatory content in mind from the onset. These providers have based products on the foundation of key regulatory content specified by the FDA and other US and global regulatory bodies, but they have built these offerings on existing platforms. For example, vendors like Qumas and NextDocs have provided life sciences-specific compliance and quality management solutions on top of existing platforms like Microsoft SharePoint.
- Independent vendors building on their own stacks: Alternatively, we also see vendors that attempted to build regulatory and compliance document management solutions from the ground up. These include vendors like MasterControl and Veeva, which market themselves as quality and compliance solutions that help regulated companies achieve compliance and Operational Excellence on the foundation of their own internally developed platforms.
What to Look for in a Solution
So what should you actually look for in a quality and regulatory document management software vendor to achieve not only immediate compliance but also end-game Operational Excellence?
- Closed-loop processes: Do the solutions facilitate closed-loop processes between document management and quality management processes like NC/CAPA, Audit, GMP, and Supplier Quality Management?
- Collaboration: Increasingly, it is becoming important to reconcile alterations and updates in documentation in real time and technology is making this kind of collaborative visibility and real-time engagement a reality. The architecture for tools like this exist, and the trend extends in this direction, so it helps to know whether vendors have built collaboration into their offering or included it on their product roadmap.
- Compliance: Whether a vendor rests on existing stacks or attempts to provide a more complete solution on their own terms, you need to establish that they offer a solution that adapts to shifting regulatory requirements, easily allows for submissions to the appropriate regulatory bodies, and is not overly burdensome to validate and maintain.
- Ease of Access/Ease of Use: This point speaks to user adoption, a common sticking point between the linkage of people, processes and technology that we discuss often on the LNS Blog, but ultimately the solution has to be easy to access from an end-user perspective and also has to be easy to use.
Given the importance of document management solutions in the role of compliance, it is fundamental that we make it as easy as possible for our frontline users to leverage the system and apply accurate data within it. When it comes to ease of use, we often use the term ‘consumer ready,’ meaning the document management system should be just as easy to use as Google, Amazon, and Facebook for searching, sharing, and accessing from mobile devices.
- Audit Trails, authorship recognition, and eSignature capabilities: More a specific technical requirement than a broad-based expectation of any document management offering, since version control and document control reside in the backbone of a robust quality and regulatory document management solution, regulators need to know where documents came from, who authored them, and who authorized them. Robust audit trail and eSignature capabilities are an increasingly expected part of an offering.
Interested in learning more about quality and compliance strategies? Read LNS Research's report below for more information on how market leaders are connecting the enterprise with next-generation solutions.
