For pharmaceutical and bioscience companies, workflow automation is no longer a luxury—it’s a necessity. In today’s intense regulatory environment, automating multifaceted signoff, check and review processes can generate significant cost savings while also ensuring compliance and supporting higher efficiency throughout the organization—from safety and training, to product development, to operations.
Ensure Regulatory Compliance
In the pharmaceutical industry, major regulatory oversight and legislation such as Sarbanes-Oxley and HIPAA create huge obstacles for streamlined process management. At the same time, decisions regarding packing, labeling, and transportation have become even more complicated since the advent of DSCSA. FDA oversight now extends from the moment a scientist in the lab gets approval to work on a new project to the time a truckload of finished goods end up in a warehouse or distribution center.
Many companies have discovered that workflow automation enables them to manage information far more quickly and reliably, helping them meet a myriad of regulatory requirements with less effort and lower cost. Automated workflow management systems catalog every decision point and action throughout manufacturing operations, quality testing, and supply chain processes. This means a complete audit trail—detailing who did what and when—is always available, whether required for an internal quality audit or an external audit from regulators.
For example, one of the most important parts of FDA regulation 21 CFR Part 11 requires that every transaction that involves machine or human logic must be fingerprinted and signed off. Manual or paper systems are fraught with failure points. Handwriting may be illegible so that the record becomes unreadable. Without appropriate safeguards in place, employees may “approve” their own work. Records can be lost, damaged, or misfiled, leading to an inability to pass an audit or retrieve a specific record in a recall.
However, logging transactions with a workflow automation system provides user name and time stamps for all process actions. Using workflow automation adds an additional layer of security by ensuring that all information entered is readable. In addition, user logging helps prevent fraudulent or erroneous approvals on critical details by uniquely linking the signer’s user ID to the document and creating an unalterable permanent record of the date and time of the signoff which can easily be viewed or retrieved from the organization’s document management system.
When it comes to employee training, pharmaceutical manufacturers must also navigate a complex maze of FDA, OSHA, and ISO certification regulations, as well as internal company procedures and policies. Workflow automation can consolidate the training plan and track all the various requirements, eliminating the need to depend on multiple people and systems.
This results in a more consistent training schedule and helps ensure that all employees receive the necessary training to perform their roles safely and meet quality standards. In addition, it provides an auditable report of when and to whom the appropriate training was provided.
There are countless other processes throughout a pharmaceutical organization that can benefit from workflow automation. These include:
- Product development: Build a structured workflow around R&D, quality, production, trials, packaging, and marketing to reduce risk, ensure compliance, avoid process bottlenecks, and speed products to market.
- Vendor qualification: Consistently screen and properly approve vendors, handle contract initiation, and route a new relationship or project contract throughout the organization for review and approval.
- Disclosure approval process: Automate request and approval tasks based on preset rules established by the organization.
- New product requests: Automated workflow solutions can provide a standardized template for requesting new products and ensure proper protocols are followed.
- Operations: Automate operation sign-offs in production, ingredient tracking by batch, and the generation of certificates of inspection or quality.
Workflow Automation in Action: A Case Study
With a merged workforce culled from two sizable organizations, the IT team at GlaxoSmithKline (GSK) struggled with diverse, disconnected request processing methods. In the absence of a standardized template or system, the IT departments were responsible for creating their own processes for handling business unit requests for service and equipment. Some used paper forms, while others used electronic ones.
GSK’s automated workflow requirements included:
- A system that could be implemented company worldwide, providing users with a single, familiar interface that was more welcoming and user-friendly.
- The capability to reduce costs incurred by individual IT groups financing the development of their request processes through the use of outside business and computer consultants.
- A solution that could work across numerous business units and legacy systems and would build on existing systems and databases without having to create a new system from scratch.
- Software that was easy to implement as well as easy to use, with no end-user training required, so it could be rolled out quickly.
The benefits were dramatic after GSK implemented an automated workflow solution from Integrify. The average interface development time for new requests dropped from three weeks to four days, and costs were slashed 96 percent. GSK has processed millions of requests through the software and is currently servicing users in more than 60 countries.
“One of the main drivers in the internationalizing of the system has been the ability to standardize processes,” said Neil Weitz, Director of IT Help in the Process and Service Improvement Organization End-User Advocacy Group at GSK.
Re-purposing eight employees covered the cost of the software. And, the return on GSK’s investment continues to grow as the number of users increases. For example, Weitz estimates it costs GSK $5.00 every time an employee calls the help desk. But many help desk calls are service or equipment requests that are simply passed along to the IT service department.
“If you’re talking about passing along 1,000 calls a month, that’s $5,000 in unnecessary calls. When we provide an online request form that’s easier than picking up the phone, we can cut those costs, as well as free up the help desk personnel for other calls,” he said.
Tips for Getting Started
Any pharmaceutical or bioscience company can quickly begin implementing workflow automation by following these three tips:
1. Look for the easy win.
Start by looking for a process with enough visibility that the benefits of workflow automation will be readily apparent, but not one that is so critical to the organization that a misstep could be catastrophic. For example, rather than try to automate the workflow for the entire production cycle at once, start with a smaller project that can serve as a proof of concept. Cleaning skids in one process or calibrating a single class of test equipment are good examples of starting small. Also, look for a process with high volume and little variability.
2. Don’t skimp on training.
Ensure that the team responsible for creating the workflow rules receives training on the tool and its capabilities. The department where the first rollout will occur should be trained on what to expect and how to respond. In addition, employees throughout the entire company should be trained on the basic concepts so they know what to expect and understand the benefits.
3. Secure management buy-in.
Any project has a better chance of success when management supports it. Make sure the management team understands the benefits of workflow automation and invest time in developing reports that show the progress of the project and the accrued savings.
For more information, visit www.Integrify.com.