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Feb 25, 2015

7 Document Management Blunders that Jeopardize Compliance

Is bad document management spoiling 
your compliance efforts? Learn how 
to fix seven common document 
management mistakes.
by James Jardine

Marketing Communications, MasterControl


Achieving regulatory compliance without any document management slipups is like walking through a dog park without getting your shoes messy. It seems nearly impossible to find a safe route to your compliance destination and there are countless potential mistakes you can make at any step along the way. Since the path to compliance is narrow and treacherous, here are seven examples of common document management mistakes that can jeopardize your compliance and a few ideas on handling these types of problems.

Inefficient Manual Paper-Based Systems
Managing documents manually simply perpetuates a wasteful system that is prone to error. Plus, manual document management systems are often responsible for introducing quality problems that can result in product defects and regulatory penalties. And don’t fool yourself into thinking you’re any better off with that hybrid paper/electronic system you’ve Frankensteined together. It’s just as inefficient.

But you’re not alone; most companies’ document management and collaboration practices are still outdated, even in a modern world where technology simplifies everything we do. According to a recent Harris Interactive survey of knowledge workers, 57 percent of those surveyed reported that they’re uncertain whether or not they are working on the right version of a document at any given time. Think of all that collectively wasted time!

Be cautious about buying into the belief that all your document management woes can be cured by a new software system, however. It’s possible that technology can even contribute to bad document management because more inaccurate or outdated information is available than ever before or because the system you’ve chosen to implement isn’t a good fit for your particular needs. Make sure that the electronic system fits your specific requirements before making an investment.

This article is related to the Whitepaper: Automating Document Control Processes. To get the full details, please download your free copy

Disorganized Document Lifecycle Management
No matter how hard you try to streamline operations, it always seems there are tasks you can’t make any less labor intensive. For most companies, document routing (e.g., for approval, distribution, archiving, etc.) is this very kind of time consuming, physically demanding chore. In fact, tracking vital documentation can become so complicated that it not only threatens efficiency but it can compromise compliance as well. Especially when the documents you need reside in several different locations. Matters are complicated further by the fact that your documents usually exist in different kinds of formats—spreadsheets, Word documents, CAD files, video, and every other file type imaginable. All these documents need to be managed securely throughout their lifecycle, usually according to the phase they inhabit along the lifecycle (i.e., draft, current, or archived).

An electronic system can alleviate the byzantine and manually burdensome aspects of document management. Plus, most high quality electronic systems are format agnostic and provide users with archiving and audit trail functionality that fully satisfy compliance requirements. Any authorized user should have the ability to peer into an electronic document management system to view a document or record’s status, past versions, metadata, and approval history from the time it was created until its present state. Another added bonus is having all your documents in a central, secure repository.

Manually Conducted Revision Control
Nothing proves to regulatory authorities that your right hand doesn’t know what your left hand is doing more than rogue documents. At best rogue documents only lead to minor inconveniences that waste the time of several workers and may necessitate some rework or scrap. At worst they can lead to product recalls and delays in getting your products on the market. Either way, they raise obvious red flags.

Certainly switching to an automated document management system with strict versioning controls is the most obvious means of controlling rogue documents. At very least you need to have a procedure for “self-destructing” obsolete documents at the appropriate time and a means to ensure everyone is working on the most current version of working documents. Most off-the-shelf automated systems are designed specifically to do just that, plus they usually include electronic signature, approval history tracking, audit trail, and related kinds of functionality geared toward compliance. In addition, the system’s functionality should include the ability to send automatic notification of document changes, approvals, triggered training tasks, and escalations. If you plan to automate your document management system, be sure your system also includes some functionality for managing printed documents. An automated system can’t help much if users are able to print hard copies of production documents that haven’t been prominently watermarked with expiration dates.

Unintuitive Administration Tools
How is your document management system administered? Maybe it’s a series of binders you have to hunt through to find the document you need. Or a room full of file cabinets managed by a fellow employee who nags you for a signature every time there is a manufacturing change. Chances are it’s not as efficient as it should be.

Your system administration tools should make it easy to find the exact information you’re looking for. Plus, you should be able to build a document approval route simply, without draining IT resources. You should also have instant access to a variety of custom or standard reports like audit trails, master lists, cycle times, and revision histories. An automated document management system can meet all of these administrative needs.   

Lack of System Usability
Practicality is essential if a document management system has any chance of being adopted successfully. Users must be able to quickly find the documents they need to do their jobs. They also prefer to access information using the same point-and-click, drag-and-drop methods they’re accustomed to using in the programs they work with every day. In fact, if a system isn’t intuitively functional, it will be avoided whenever possible. That’s why browser-based document management systems continue to gain popularity. They are familiar, easy to use, and helpful for connecting employees, customers, and supply chain members regardless of their physical location. Users also benefit greatly from systems that feature search capabilities that allow them to find documents based on keywords or word strings.

Closed System Architecture
It is nearly impossible to compile useful information about product quality and compliance if you are gathering data from incompatible sources and disparate applications. Open system architectures, platforms and industry-common SQL database technologies can provide you with flexible integration gateways across the quality system so you can connect vital processes (e.g., integrate nonconformance with training, tie customer complaints to CAPA, etc.). If you are able to connect your quality systems more efficiently and across more points along the value chain, you will be able to leverage your data better and make more proactive, informed decisions about your product.

Inadequate Implementation and Validation Tools
If you are doing business in a regulatory environment and you are implementing an electronic document management system, you’ll need a system that can be installed and validated according to regulatory guidelines. Your willingness (or inability) to tolerate any risk of noncompliance and bear the validation workload will dictate the level of validation you’ll need. Some vendors are prepared to do all the heavy validation lifting, while others are more than willing to let you sink or swim on your own. Which you choose is entirely dependent on the risk tolerance of your organization. What is vital, however, is that you ensure that the solution provider has been audited by companies relative to your own in terms of size and industry and that the provider has a respectable user-base of references.

The availability and quality of educational and training tools is another vitally important element of the decision to implement an electronic document management system. There should be an adequate variety of training tools for both beginning and advanced system users that not only provides thorough education on the system but is adaptable to your industry and unique business culture.

Conclusion
When it comes to maintaining compliance, an electronic document management system can be a life saver. An electronic solution can help you streamline operations, accelerate compliance, and reduce the time it takes to get your product to market. Just remember that no matter how great the technology is, bad document practices will only lock in systemic problems and reinforce adverse document management issues.




James Jardine is a marketing communications specialist at MasterControl. He has a bachelor’s degree in journalism from the University of Utah and is based in MasterControl’s headquarters in Salt Lake City, Utah. 








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White Paper: Automating Document Control Processes
Product Data Sheet: MasterControl Documents™
Product Data Sheet: MasterControl Collaboration™
White Paper: MasterControl: What's the Return on Investment?