Compliance in the Lab

Builds culture of compliance

Employees at all levels should have an in-depth understanding of company policies and embrace their roles in ensuring they are followed. An environment where everyone gets to share responsibility for compliance and integrity should be established and this includes collaborative design in terms of updating compliance protocols and decision-making. There should be nurturing of positive attitudes towards regulatory compliance through recurring discussion of compliance-related topics and coming up with certain expectations.

Ensures proper training and supervision 

Having mandatory and regular compliance training guarantees that the lab workforce is aware of all the salient laws, regulations and internal policies that dictate daily operations. The training format varies (whether online, as a classroom training, or blended learning) and should prepare and empower lab workers in handling different situations they face in the workplace. Bringing an outside expert to present new and important compliance issues can also help.

Establishes standard operating procedures (SOPs)

Effective SOPs are fundamental in accomplishing the ever-changing regulatory requirements and obligations. It establishes uniform and detailed instructions on how a specified standard is performed in lab operations, thereby increasing the product or study quality, improves accountability and maintains operational efficiency. Having SOPs exudes the notion that the organization is serious about defining, documenting, and following standard procedures.

Documents procedures

The presence of proper records critical to any compliance program as it provides auditors with evidence that the policies and processes follow relevant requirements. Documenting all lab processes, procedures, and internal controls and having a centralized repository for all documents to organize proof is essential.

Advances compliance through audits 

Compliance audits, which is a comprehensive review of an organization’s policies and procedures, check the lab’s adherence to regulations set forth by government agencies. This also ensures that the lab follows its own codes of conduct and determines non-compliance areas in order to suggest remediation steps to avoid inefficiencies.

Generates business value through compliance 

When a lab puts a premium on following appropriate steps towards compliance, it demonstrates a commitment for ethical behavior. This spurs improved information governance, data analysis and reporting which in turn offers actionable insights and help in making informed decisions.