Compliance

Compliance sounds complicated.

In reality, it’s pretty simple if you let SLIMS help you do the job!

Certification

Today, compliance is a general issue in science as professionals as well as academic environments are getting more and more regulated at multiple levels. After a series of scandals involving scientific cheating and falsifications, governments as well as Academic and Company Boards have introduced strict regulations on compliance that touch data auditing and traceability among several other issues. As a result, scientists working in modern, compliant environments are under constant pressure to deliver validated results in the shortest time possible under regulated procedures.

Therefore, commercial Laboratory Information Management System (LIMS) and Electronic Laboratory Notebook (ELN) providers entering this regulated market are required to satisfy these needs and develop tools that support these strict regulations. This is why we have developed SLIMS in such a way that allows our customers to have all you need to make their lab operations compliant or to freely use it if they already are compliant. From detailed history tracking to witnessing and approval processes, the platform has a fine grained security model with a number of features that will support the needs of their environment.

Genohm is an ISO 9001:2015 certified company. ISO standards are set by the International Organization for Standardization to ensure quality, safety and efficiency. The ISO 9001:2015 specifies all the requirements needed for a quality management system or QMS. This certification implies that Genohm has set up an internal QMS that enables the company to provide a product, SLIMS and services related to its installation, deployment, training and others that meet the requirements from customers and regulatory bodies. Genohm has set up internal certified processes and quality check points that allow the constant high standard quality of software development. This way, our customer base can directly profit of the standardized quality of SLIMS when they use the platform to manage their laboratories.

The ISO 15189 certification is required in medical laboratories environments. This international standard sets the specific requirements in terms of quality and competences that are required for a quality management system or QMS particular to medical labs. SLIMS is developed under ISO 9001 requirements and its features on the quality management of laboratory-related processes, samples, patients, data, equipment, results, reports, data auditing and traceability but not only that, fully support the ISO 15189 standard.

Therefore, SLIMS can fully support the ISO 15189 process of accreditation of a medical lab or it can easily be deployed to support the operations of an already accredited lab.

The competence of testing and calibration laboratories is regulated by the ISO 17025 certification. This international standard specifies the requirements for such a lab in term of competences to carry out tests, calibrations and sampling. SLIMS is developed under ISO 9001 requirements and its features on the quality management of laboratory-related processes, samples, patients, data, equipment, results, reports, data auditing and traceability but not only that, fully support the ISO 17025 standard.

Therefore, SLIMS can fully support the ISO 17025 process of accreditation of a testing and calibration lab or it can easily be deployed to support the operations of an already accredited lab.

What is usually referred to as 21 CFR Part 11, is in fact the Part 11 of the Title 21 of the Code of Federal Regulations (CFR) issued by the executive departments and agencies of the federal government of the United States of America. It establishes the Food and Drug Administration (FDA) regulations that deal with electronic records and signatures (ERES). In particular, Part 11 specifies the criteria required for electronic records and signatures to be considered trustworthy, reliable, and equivalent to paper records. SLIMS is developed under ISO 9001 requirements and its features on the quality management of processes such as data auditing and traceability but not only that, fully support the 21 CFR Part 11 regulations.

Therefore, SLIMS can fully support the 21 CFR Part 11 process of accreditation of a FDA-regulated entity or it can easily be deployed to support the operations of an already accredited lab.

More about 21 CFR assessment at the following link here.

HIPAA is the acronym of the Health Insurance Portability and Accountability Act enacted by the Congress of the United States of America. The Title II of HIPAA defines, among other things, the policies, procedures and guidelines to secure the privacy and security of health information that may identify an individual. The HITECH Act stands for Health Information Technology for Economic and Clinical Health Act. Under this act, the United States Department of Health and Human Services Act has the mission to promote and expand the adoption of health information technology.

Genohm is a software company and not a healthcare organization. Therefore it does not meet the criteria of a “covered entity” as defined by HIPAA and HITECH. It does not collect, analyze or transfer personal health information. Nevertheless, Genohm will establish a contractual HIPAA “Business Associate” relationship in order to cover any client as appropriate.The company respects and observes the information security and confidentiality in accordance to privacy standards and following the intentions of HIPAA.

Genohm and its software SLIMS, have taken a number of administrative, technical and physical safeguard steps and are therefore compliant with the HIPAA security rule. Relevant documentation is available upon request.

CLIA is the acronym for Clinical Laboratory Improvement Amendments. They are United States of America federal regulatory standards that apply to clinical laboratories that perform tests on humans, with exceptions of clinical trials and basic research. The CLIA Program sets standards and issues certificates to ensure accuracy, reliability and timeliness. Genohm is a software company and not a testing/equipment provider. Therefore, it does not meet the criteria for its software to be certified by CLIA.

Nevertheless, as a matter of practice and operations, Genohm respects and commits to the need for quality and accuracy in the lab testing process and will work with a client as needed to obtain any necessary certifications as required by the different relevant authorities. The SLIMS software, and related data, resides on client hosted, on-premise systems at hospitals or laboratories which may run tests that would need CLIA/CAP certification. Since the standard implementation has Genohm providing software which overlays on client lab equipment/lab tests, the client is responsible for any regulatory/security/privacy requirements based on the tests that they run in their environment.

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