Quality and Compliance
Transparent sample management and quality-focused processes
MEDEORA
Together, we will create the right solution for you.
Quality and Compliance
Transparent sample management and quality-focused processes for biobanks and research laboratories
Quality-assured research requires reliable information about biological materials and the associated data. The origin and storage locations of samples must be traceable, access must be regulated, and any changes must be documented.
The BioARCHIVE Study & Sample Platform supports these tasks with sample and inventory management, study assignment, granular access controls, an audit trail, and electronic signatures. At MEDEORA, a quality management system that continues to be managed in accordance with ISO 9001 forms the foundation of our business processes.
Combining Samples and Scientific Context
BioARCHIVE is designed to manage biological materials and their associated data. The platform links sample information to inventory items and studies. In this way, it supports biobanks, research laboratories, and institutions that manage reference, control, or validation materials.
The focus is on the clear connection between materials, data, and the scientific context.
Which functions support quality and compliance?
Sample Traceability and Inventory Management
BioARCHIVE enables the structured management of sample provenance, storage locations, and related information. Assigning samples to studies helps document the scientific context.
Differentiated Roles and Permissions
Customizable roles control read, write, and delete permissions. Permissions can be tailored down to individual fields and forms. Users are granted access to the information, cases, and studies that have been made available to them.
Traceable Changes via the Audit Trail
The audit trail documents changes made to the system. It facilitates the verification of data changes and contributes to the traceability of electronic records.
Electronic Signatures
BioARCHIVE provides functions for electronic signatures. Their use and configuration are tailored to the respective technical and organizational requirements.
The specific range of functions depends on the version used, the modules, and the configuration.
Standards and Regulations: Putting Our Contribution into Context
Which requirements are relevant depends on your institution’s area of application. The following overview describes how existing BioARCHIVE functions address these requirements and identifies additional considerations.
| Standard or Set of Rules | Contribution from BioARCHIVE | Additional considerations |
|---|---|---|
| ISO 20387 – Biobanking | Sample traceability, inventory management, study assignment, and structured management of associated data. | Requirements for the biobank as an organization, its procedures, and documentation thereof. |
| ISO 15189 – Medical Laboratories | Specimen-related information management, differentiated access rights, and documentation of changes. | Additional requirements for medical laboratory processes, quality management, and the specific use of systems. |
| ISO/IEC 17025 – Testing and Calibration Laboratories | Management of reference, control, and validation materials, as well as related information. | Requirements for methods, competence, quality assurance, and documentation of the laboratory. |
| EU GMP Annex 11 and FDA 21 CFR Part 11 | User accounts, role-based access rights, audit trails, and electronic signatures as relevant technical components. | Applicability, specific functional design, system validation, operating procedures, and required documentation. |
| GDPR | Granular permissions help restrict access to personal information. | These include legal bases, scope of data, retention and deletion, as well as technical and organizational measures. |
This classification describes support for individual requirements. It does not constitute a statement regarding the software’s certification or full compliance in a specific use case.
Quality Management at MEDEORA
For us, quality applies to both the functions of BioARCHIVE and our company’s processes.
MEDEORA was ISO 9001-certified for several years. Even after the certification expired, we continue to operate our company in accordance with the requirements of ISO 9001. As a result, this quality management standard remains the foundation of our business processes and their continuous improvement.
There is currently no ISO 9001 certification. The previous certification and the quality management system, which continues to be operated in compliance with the standard, pertain to MEDEORA as a company; they do not constitute certification of the BioARCHIVE software.
Compliance arises from collaboration
Software features, organizational rules, and proper operation together form the foundation for meeting your requirements.
Therefore, responsibilities, authorizations, workflows, and required checks must also be defined for the use of BioARCHIVE. For regulated applications, this includes, in particular, the assessment and, if necessary, validation of the system for its intended purpose.
We will discuss with you which requirements BioARCHIVE supports and what additional measures or documentation are required for your project.
Frequently Asked Questions
Is MEDEORA or BioARCHIVE certified?
MEDEORA was certified to ISO 9001 and continues to operate in accordance with the requirements of this standard. It does not currently hold a valid certification.
The other standards and regulations listed on this page describe relevant operational requirements and the contribution of BioARCHIVE’s functions. This does not imply that the software is certified or that the respective application is generally compliant.
Does BioARCHIVE automatically comply with Annex 11 or 21 CFR Part 11?
BioARCHIVE offers relevant technical features for this purpose. Whether these are sufficient in a specific application must be evaluated in conjunction with the configuration, processes, operation, and required documentation. A blanket assurance of compliance cannot be derived from this.
Does BioARCHIVE replace a quality management system?
BioARCHIVE supports sample- and data-related information management and documentation. It does not replace a comprehensive quality management system that includes tasks such as CAPA management, supplier evaluation, or training administration.
What is the main difference compared to a routine LIMS?
BioARCHIVE focuses on biobanking, research, and the management of biological materials in a scientific context. Requirements for comprehensive routine diagnostic laboratory management are reviewed separately to ensure they are covered.
Reviewing Your Requirements Together
Would you like to manage samples in a traceable manner, control access in a targeted way, or document changes?
Talk to us about your business processes and quality requirements. We’ll show you the available features and work with you to determine the requirements for your specific application.
Please contact us to schedule a consultation.
MEDEORA – Your partner for digital laboratories and connected research.
