Regardless of the industry or lab size, businesses must follow specific state, federal, and international laws relevant to their operations. In the US, it may involve, for example, following rules set forth by the Occupational Safety and Health Administration (OSHA) to ensure the lab operates under safe working conditions. Compliance may also involve adhering to company policies and procedures that help drive accountability in the workplace.
Regulatory compliance pertains to specific industries as well. For instance, food manufacturing sites should comply with CODEX, which develops harmonized international food standards, guidelines, and practices to protect consumers' health and ensure fair food trade practices. The pharmaceutical industry, on the other hand, is gearing up to adopt the ISO IDMP framework, designed to standardize the identification of medicinal products across global regulators, manufacturers, suppliers, and distributors.
The benefits of an effective regulatory compliance program go well beyond avoiding lawsuits or costly fines. It ensures the alignment of corporate organizational structure, people, and processes, to manage risks, attend to customers' expectations, and build a positive brand reputation.
This article outlines several elements of a successful corporate compliance program in the lab.
Build a culture of compliance
Laboratories can best achieve compliance when it becomes a part of the organization culture. This means employees at all levels understand company policies and embrace their part in ensuring they are followed.
A key step in building a culture of compliance is establishing an environment where everyone shares responsibility for compliance and integrity. Lab managers can encourage the collaborative design or update of compliance protocols to ensure ownership and decision-making are shared. Lab leadership must also nurture positive attitudes about regulatory compliance. This can be achieved, for example, by favoring good relationships with regulatory agencies and institutional officials. Rather than viewing these experts as antagonizers, lab managers can invite such experts into their labs to give presentations or share best practices.
Making compliance a recurring discussion topic also helps foster a culture of compliance. For instance, leadership can dedicate lab meetings to discuss regulations changes or a case example. In addition, lab leaders can set compliance expectations and incorporate them into job descriptions, reviews of employee performance, recurring meetings, and other events.
Ensure proper training and oversee it
Mandatory, regular compliance training ensures the lab workforce understands all relevant laws, regulations, and internal policies governing day-to-day operations. Compliance training can be carried out online, as classroom training, or as blended learning; the training format can vary as long as it ensures employees know why and how they must adhere to compliance rules. A compliance training must also prepare lab workers to handle different situations they may face in the workplace.
Larger organizations usually have a compliance manager—or a similar designation—responsible for double-checking procedures and documentation, handling compliance matters, and providing training. Occasionally, bringing in outside experts to present on new regulations or important compliance issues can help the lab operate at its optimal level.
Not only should every employee participate in compliance training, but companies should keep accurate training records, including attendance registers, training manuals, and the means used to verify training understanding. Furthermore, manuals documenting the compliance structure, as well as the compliance program policies and procedures, should be readily available to inspectors, auditors, and employees. This helps reinforce the commitment to compliance, facilitate the adoption of best practices, and maintain consistency in lab compliance training efforts.
Establish standard operating procedures
Implementing effective standard operating procedures (SOPs) is fundamental to fulfilling ever-evolving regulatory requirements. SOPs establish uniform and detailed instructions to achieve a specified standard during lab operations. This helps increase product or study quality, improve accountability, and maintain operational efficiency.
SOPs are a regulatory requirement, too. For example, the FDA, ISO, and ICH guidelines frequently mention requirements for SOPs. Besides helping companies fulfill regulatory obligations and improving operations, effective SOPs also provide a solid foundation for training new employees. SOPs document step-by-step procedures, therefore they can guide employees on how to appropriately complete tasks. Moreover, when staff is trained using SOPs, they learn from the very beginning that the organization is serious about defining, documenting, and following standard procedures.
Proper records are critical to any compliance program since they provide auditors with formal evidence that your policies and processes follow relevant requirements. For instance, if a compliance program involves annual security training for employees, the training documents can provide evidence that employees are being trained. Similarly, documents including security audit reports and SOPs can be used to establish and prove compliance.
Documentation requirements vary according to the audit scope. Regardless of standards, needs, and requirements, documenting all lab processes, procedures, and internal controls is critical to compliance program success. Investing in audit management software to have a centralized repository of all your documents can relieve you from collecting, sorting, and arranging documents. Audit management software also facilitates access to required documents and increases security, ensuring better regulatory compliance.
Advance compliance through audits
A compliance audit is a comprehensive review of an organization's policies, procedures, processes, and documentation. It serves to determine whether they are aligned with existing regulations.
An external audit will check business adherence to regulations set by government agencies or other competent authorities. For instance, an external compliance audit evaluating adherence to the Environmental Protection Act will ensure labs implement waste disposal methods that maximize safety while minimizing environmental impact. External audits usually require independent third-party auditors to prove compliance.
In contrast, internal audits are conducted to determine whether a lab follows its own codes of conduct or whether it is prepared for an upcoming external compliance audit. In this case, an internal auditor with high knowledge of the industry regulations can perform the auditing process. The auditor will identify non-compliance areas and recommend remediation steps to avoid inefficiencies or penalties such as fines, litigation, or business suspensions.
Lab managers and employees should consider compliance audits—as well as proper auditing preparation—a regular part of the job. This includes conducting routine equipment calibration activities, following an equipment maintenance plan, facilitating staff training, ensuring SOPs are up to date, completing all the validation activities with relevant documentation, and performing regular internal audits.
Embracing audits is an excellent way to prioritize compliance in your organization.
Generating business value through compliance
As global regulations increase and become more complex, and as stakeholder expectations grow, organizations face more compliance risks than ever. By encouraging best practices, lab managers can help staff navigate the challenging world of compliance and incorporate such practices into everyday lab work.
When a lab puts the appropriate steps in place to prioritize compliance, it not only demonstrates a commitment to ethical behavior to regulators, but also to employees and clients. Moreover, compliance efforts can catalyze improved information governance, data analysis, and reporting, which can provide actionable insights and help businesses make more informed decisions.
In sum, a solid compliance program offers organizations benefits beyond regulatory and legal conformity. It improves operational efficiency, helps organizations unlock major growth opportunities, and protects a lab's most important asset: its reputation.