CC Software LLC (dba Confident LIMS)

Introduction

This letter describes the ISO 17025 requirements met by CC Software LLC (dba Confident LIMS), the ISO accreditation status of CC Software LLC, and the associated requirements to support ISO 17025 accredited laboratories using the Confident LIMS laboratory information management system.

ISO compliance requirements for software companies are different from ISO compliance for laboratories. For software companies, ISO compliance usually pertains to aerospace/defense, healthcare/medical, finance/payments, and government software. These kinds of software systems are often regulated and therefore subject to frequent audits by regulators. Software companies for analytical testing laboratories are currently not regulated and therefore are not required to be ISO certified.

Although laboratory regulators currently do not require ISO certification for software providers to analytical testing laboratories in the industries in which we participate, regulators do sometimes require ISO 17025 certification of laboratories. For these laboratories to be certified, regulators do not require laboratories to use ISO-certified software, so long as their software empowers the laboratories to be compliant with ISO requirements.

Although CC Software LLC is not ISO certified, CC Software LLC’s Confident LIMS software system does empower its laboratory users to be compliant with ISO 17025 requirements. CC Software LLC has a long and publicly demonstrable track record of providing software to analytical testing laboratories that have gained and/or retained ISO 17025 certification while using Confident LIMS. To my knowledge, no laboratory using Confident LIMS has lost its ISO 17025 certification due to faults or deficiencies with Confident LIMS software.

Specifically, CC Software LLC operates in accordance with, and the Confident LIMS software system provides functionality to meet, applicable ISO 17025 guidelines, including:

4.2 Confidentiality

As stated in our Terms of Use (https://www.confidentlims.com/terms-of-use/) and Privacy Policy (https://www.confidentlims.com/privacy), CC Software LLC is responsible, through legally enforceable commitments, for the management of all information entered into our software system by the laboratory during the performance of laboratory activities. CC Software LLC will seek explicit consent from the laboratory and/or the laboratory’s client in advance of the information being placed in the public domain. Except for information that the laboratory or the laboratory’s clients make publicly available, or when agreed between CC Software LLc, the laboratory, and the laboratory’s client (e.g. for the purpose of responding to complaints), all other information provided by the laboratory or the laboratory’s client to CC Software is considered proprietary information and is regarded as confidential.

All laboratory and client users are required to enter a valid username and password to access the software system. CC Software LLC encrypts all data in transit between the laboratory users’ terminals and our secure cloud database managed by Amazon Web Services and located in the United States.

5 Structural requirements

CC Software LLC is a Delaware limited liability company and a wholly-owned subsidiary of Kassen Company, a Delaware C-corporation. CC Software LLC is legally responsible for its software development activities and software platform. CC Software LLC has a management team that has overall responsibility for the company’s software development procedures and software platform. CC Software LLC has the personnel, who irrespective of other responsibilities, have the authority and resources needed to carry out their duties.

6 Resource requirements

CC Software LLC has available the personnel, facilities, equipment, systems and support services necessary to manage and perform its software development activities to serve our laboratory users and their clients.

6.4 Equipment

CC Software LLC provides only the Confident LIMS software laboratory information management system and related support services to laboratories and their clients. CC Software LLC does not provide hardware, measuring instruments, measurement standards, reference materials, reference data, reagents, consumables or other auxiliary apparatuses that may be used by laboratories for the correct performance of laboratory activities and that can influence their analytical results.

6.6 Externally provided products and services

CC Software LLC ensures that only suitable externally provided products and services that affect our software and, subsequently, laboratory activities are used. CC Software LLC has a procedure and retains records for defining, reviewing, and approving the software system’s requirements for externally provided products and services; defining the criteria for evaluation, selection, monitoring of performance, and re-evaluation of external providers; and taking any actions arising from evaluations, monitoring of performance and re-evaluations for the external providers.