In the age of electronic data, it’s shocking that 75 percent of manufacturers still rely on manual data collection. While it may seem cheaper to manually administer quality and safety programs on paper, it is not efficient and leaves much room for error. When data collection is not done properly, records can be lost or misplaced, making it difficult to retrieve information, ultimately resulting in costly delays, lost business opportunities, and frustrated plant personnel. Further, in the food and beverage, pharmaceutical, and medical device industries, electronic record keeping is required by the Food & Drug Administration (FDA) 21 CFR Part 11.
To be compliant and ensure safety for consumers, manufacturers must properly manage documents and records on monitoring traceability and recalls, providing corrective and preventive action (CAPA), and handling food safety audit requirements.
However, whenever a business moves from paper to electronic records, the shift can feel overwhelming to staff and management alike. So, it’s best to develop a plan and take it one step at a time. Here are the four steps necessary to convert paper-based processes to electronic record keeping.
1. Standardize Naming Conventions
This step is first and foremost. A standardized naming convention creates a set of official standards for file naming and storage policies within the organization. To accomplish the change, your team will need to work through the various permutations of testing protocols, naming conventions, and specifications that almost certainly exist in the company, and filter them down to the bare minimum. This is incredibly important because records can then be stored logically, retrieved easily, or browsed efficiently, saving time and minimizing frustration.
Here are a few tips for getting started:
- Keep file names short, but meaningful.
- Avoid unnecessary repetition and redundancy in file names and file paths.
- Use capital letters between words, not spaces or underscores.
2. Select the Deployment Method
Deciding on an implementation architecture for your data collection software is a critical factor. If it’s necessary to get up and running quickly with minimal internal IT structure, then a cloud solution may be in order. But if there’s already a robust and well-maintained infrastructure in place, then an on-premises solution could be preferable.
Also consider ongoing maintenance and upkeep. Will someone be available on staff to maintain upgrades and licensing or would it be beneficial for the software provider to handle that in the cloud? Cost is also a concern; cloud solutions incur a recurring expense and on-premises deployments often require updated technical infrastructure. But, if you carefully calculate all software expenses, not just those affiliated with deployment, you’ll have a better understanding of which deployment option is right for your organization.
3. Digitize Records
Converting the existing paper forms to electronic format can be perceived as a daunting task, but working closely with the software provider’s engineers can greatly reduce the effort. Relying on their experience to efficiently implement a best-practice solution will provide your best chance for ultimate success.
4. Instill Change Management
Finally, the last hurdle will be to make sure everyone is using the software properly and taking full advantage of its features and functionality. Never assume that because there is a change, everyone will know how to adjust. Take time to ensure that every employee knows the proper standards and protocol to make this a seamless effort. Creating a culture of quality and instilling proper change management initiatives will smooth the way to full usage and benefit.
Even though there are only a few steps needed to convert from paper-based to electronic record keeping, it is still recommended that manufacturers start small and then expand iteratively. This agile approach allows the manufacturer to gradually become more comfortable with the software system and how it may change the way staff members think about automated data collection.
Once managers and operators truly understand the power they have at their fingertips, they will begin to modify their approach to gathering and entering quality data into the system. This iterative approach can also be less disruptive to overall manufacturing operations and the individual users, reducing the impact of the change.