Laboratory compliance encompasses procedures and policies to ensure consistent and reproducible outcomes. Many laboratories face challenges associated with compliance, given the complex and rapidly evolving laboratory environment. A compliance service provider can help laboratories perform necessary compliance work and keep pace with rapidly changing technologies.
Common compliance challenges
With increasing digitization, many laboratories have transitioned to electronic records and signatures. 21 CFR Part 11 guidelines pertaining to electronic records and electronic signatures were introduced in 1997, and the Food and Drug Administration (FDA) has since placed increasing importance on data integrity. According to Tony Pezzolo, product manager, validation at PerkinElmer, it is not necessarily changing regulations surrounding data integrity that pose challenges for labs, rather, evolving lab technology and computer systems that create greater complexities.
“Lab technology and computer systems have changed, grown more complex in some ways, and in other ways become more streamlined around their Part 11 compliance,” says Pezzolo. “The big challenge is to come up with a singular set of policies and practices for all data integrity aspects and scenarios. This is complicated by the fact that vendors supplying equipment for the lab are producing software with differing levels of Part 11 compatibility. This puts lab managers in the difficult position of dealing with the fragmentation and complexity,” he says.
Personnel changes and resource realities may also be problematic. It can be difficult to ensure an individual or individuals with the necessary compliance knowledge and training are on staff at all times. According to Gary Grecsek, vice president/general manager, Global OneSource Enterprise Laboratory Services at PerkinElmer, it is important to designate compliance responsibilities to ensure they are not overlooked, but incorporating these responsibilities into existing roles is challenging. “Compliance as a priority or as a core job responsibility is not often clearly communicated to lab personnel and can compete with their core responsibilities and the work they want to be focusing on—doing science,” he explains.
Budget constraints pose an additional challenge, especially if labs fail to account for compliance costs in the early stages of laboratory construction or relocation. According to Grecsek, “construction and instrumentation will all be factored into the timeline and budget—but rarely will the time and costs associated with validating equipment, updating SOPs, or completing employee compliance training be considered.”
Considering external experts
Enlisting the support of an external compliance service offers several potential benefits. Labs may take advantage of the flexibility to apply resources as needed, as compliance work demands tend to fluctuate. “Steady flows can dramatically accelerate (and then fall again) for any number of common compliance reasons like audits, new equipment purchases, or lab moves,” explains Grecsek. “The ability to temporarily partner with a compliance service provider helps lab teams meet the demands of a ‘bolus’ of work and provides a more desirable model [as opposed to] increasing permanent staff.”
A reliable partner can also help laboratories keep pace with new developments and requirements. Service providers have experience working with a wide range of clients and are in tune with the changing regulatory environments. With this expertise, a service provider can help labs increase performance by reducing regulatory risks and pain points.
Working with a compliance partner also makes it easier to implement industry best practices. “A good partner will likely know through experience the best way to configure and manage the majority of systems in a lab from a data integrity perspective, which will save a significant amount of time—getting the lab manager out of the development sandbox much more quickly,” explains Pezzolo.
With multiple compliance services providers to choose from, it is important to consider the level of experience. Grecsek recommends choosing a provider with a significant presence among other organizations within the industry. “This is the best way to ensure that you are able to leverage the best practices that are developing in your industry,” he explains. Ensuring that the provider implements consistent global processes will also reduce compliance risks. Ultimately, “the lab is a unique environment, with unique technology and unique compliance challenges,” says Grecsek. As such, it is essential to work with a compliance service provider that understands your specific compliance needs.