Every Lab is a Regulated Lab
Industry Insight May 12, 2014
There’s an interesting misconception in the research arena that “regulated” labs are only those labs that manufacture drugs and must follow Current Good Manufacturing Practices (cGMP) practices because they are required by law to do so.
But cGMP is only one of hundreds of regulations; there are numerous others with which research laboratories of all types must comply. There are regulations that require labs to report toxic and hazardous chemicals on site. There are regulations that require tracking and reporting certain chemicals any time a site exceeds a maximum allowable quantity (MAQ). There are safety regulations such as the EPA’s “Right-to-Know” requirement, which specifies that for every chemical there needs to be a corresponding Safety Data Sheet (SDS) that explains the chemical’s properties and provides safe handling instructions. There are regulations from the EPA, FDA, DEA, DHS, CDC, DOT, OSHA and more. In a sense, all laboratories are regulated to some extent because all laboratories handle chemicals that are subject to regulatory oversight.
Cost of Noncompliance
Further, the cost of noncompliance with these regulations is increasing. Ignorance is no excuse. When lab accidents occur, the Chemical Safety Board investigates the incidents thoroughly. Not only are organizations being held criminally and fiscally accountable, but so are Lab Managers if training or documents are not current and could have been a root cause. Fines are being levied daily until compliance is achieved. In many cases, the lab has never been audited for regulatory compliance. Invariably auditors unearth inefficient and inconsistent processes as well as inaccurate reports if any.
Understanding which agencies require reports and ensuring that the reports are accurate can be very difficult to track and manage. But when has difficulty been an acceptable excuse?
In fact, EHS Today reports that there has been a 30-40% increase in regulations that affect site safety and compliance – a trend that is set to continue as many regulations are significantly out of date and out of touch with today’s laboratory needs and workflows. Further, while a significant number of these regulations have only required voluntary compliance, because too many very visible accidents have occurred lately, voluntary compliance will be replaced by mandatory compliance.
Unfortunately, many laboratories are still stuck in outdated methodologies too. The current demanding environment that focuses on maximizing workflows to maximize lab staff productivity is only slowly driving conversion from paper-based to digital processes that support these high demands.
The intense focus on Big Data and the data deluge are two of the challenges that laboratories are trying to meet that are similar to regulatory compliance challenges. Both involve better data management and both involve digital solutions in order to keep pace.
Two very different upcoming conferences provide solutions for addressing these two challenges. The Helsinki Chemicals Forum and European Laboratory Automation.
Helsinki Chemicals Forum
The Helsinki Chemicals Forum (HCF) is focused on issues concerning the European Chemicals Agency (ECHA) REACH (Registration, Evaluation, Authorization and restriction of CHemicals) regulation, which seeks to control hazardous materials imported into Europe.
HCF provides a forum to examine not only the REACH standard within Europe but also how it fits within the global community of new standards that many countries are implementing to better manage chemical safety and to reduce exposure to toxic substances.
HCF will be held at the Helsinki Exhibition and Convention Centre from 22-23 May 2014. HCF will consist of four panels covering the following topics: EU and US chemicals regulations; chemicals used in fracking; recent development in chemicals management around the world; and, raising the baseline on sound chemicals management. The program includes representatives of international chemical industry organizations and authorities from CEFIC, CIEL, the European Commission, FDA, OECD, ECHA, Environment Canada, and the American Chemistry Council. For details, visit http://www.helsinkicf.eu.
European Lab Automation (ELA) 2014
The 4th annual European Lab Automation (ELA) is an exhibition and series of co-located concurrent conferences. The ELA 2014 exhibition will be held in parallel to Advances in NGS & Big Data, High Content Analysis, Advances in Automation & Robotics, Advances in qPCR & dPCR and Advances in Cellular Assays & Cell Culture. The conference tracks offer significant detail about cutting-edge technology on everything from next-generation sequencing technologies to automation and robotics. ELA will be held at the Fira Barcelona Gran Conference Centre from 14-15 May 2014 in Barcelona, Spain.
A brief highlight of each ELA track follows:
Advances in NGS & Big Data will provide insights into the latest developments in next-gen sequencing technologies and applications, including the growing use of NGS in the clinic and in diagnostics, as well as developments in sequencing platforms and methods.
High Content Analysis will feature the latest developments in high content technologies and their applications, including novel 3D cell based screening methods, the use of model organisms, and live cell imaging approaches as well as the evolving use of microfluidics in this field.
Advances in Automation & Robotics will dive deep into the use of robotics in biobanking, drug discovery and development and aspects of compound management.
Advances in qPCR & dPCR will examine new developments in qPCR technology, particularly improvements to qPCR design, the acquisition of accurate data, and efficient data analysis. Focus will also be given to the use of dPCR in the clinic, covering applications such as infectious disease diagnostics and cancer detection.
Advances in Cellular Assays & Cell Culture will focus primarily on bio-processing technologies and applications, featuring both up-stream and down-stream bio-processing as well as technology trends, end-user application segments and new approaches.
Laboratories are producing vast amounts of data, necessitating new methods for managing and sharing that data efficiently. Getting a handle on data is proving to be one of the key indicators for organizational success; without it the labs will flounder. Without their labs, the research organization will flounder. ELA 2014 provides an excellent opportunity to learn about the tools available to manage lab data and how other laboratories are solving the challenge.
Regardless of whether your lab is producing a regulated material, your lab is subject to regulations and can, by that definition, be considered a regulated lab.
Solving regulatory compliance issues, just like solving lab research data management challenges, can be greatly advanced with the use of digital systems and solutions that streamline workflows while driving data accuracy and accessibility.
Post by Technology Networks Informatics Editor Helen Gillespie