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IGOR helps you take those regulatory hurdles.

Navigating the regulatory landscape can be challenging, but with IGOR, compliance becomes manageable.

Designed to streamline your documentation processes, IGOR helps you keep your documentation FDA 21 CFR Part 11-, HTA-, and GLP-compliant.

A team of scientists working together to ensure regulatory compliance

Taking the "scary" out of regulatory compliance.

From the FDA’s GLP, GMP, and 21 CFR Part 11 to standards set by the Human Tissue Authority (HTA) and the European Medicines Agency (EMA) - the regulatory landscape is complex, and sometimes scary. 

 

IGOR was built to assist your team in taking those regulatory hurdles. It not only provides you with a robust platform that meets the technical requirements for electronic records as defined by the FDA, IGOR also offers additional features that help you navigate these complex regulations effortlessly. 

In line with 21 CFR Part 11 guidelines, IGOR provides a closed system that can only be accessed by authorized individuals. Access rights and user permissions can be fine-tuned on a user-by-user basis.

IGOR automatically tracks changes to each lab notebook entry and stores the full version history for easy auditing, regulatory compliance and IP protection. Data files uploaded and stored in the Experiment Documentation System are also fully versioned to avoid accidental deletion or over-writing of raw data.

The Sign & Witness feature allows you to sign a lab notebook entry or SOP with a 21 CFR Part 11–compliant digital signature & send it to a team member for review and witnessing or approval. IGOR tracks the review and approval history of SOPs and notebook entries for audit purposes. 

Once signed by both, the author and the witness, lab notebook entries are locked to prevent further editing. But don't worry if you missed an error in your write-up - IGOR allows you to make corrections to a locked notebook entry in a way that still complies with regulations.

FDA 21 CFR Part 11 - Compliance

Icon representing regulatory compliance of research documentation

Human Tissue Authority (HTA) - Compliance  
(for our customers in the UK)

ELN for HTA-compliance

IGOR facilitates complete traceability of human tissue samples from when they arrive on-site to disposal, making it an invaluable software tool for research teams that need to adhere to the stringent regulations set by the Human Tissue Authority (HTA). 

Through its sophisticated sample management system, IGOR offers complete inventory control and meticulous tracking of samples and biospecimen. Each sample is assigned a unique ID number when it's added to the system, crucial for maintaining the integrity and traceability of the sample. Precise mapping of biospecimen locations makes it fast and easy to get an overview of all HTA-relevant samples within your facility, or to locate a specific biospecimen of interest, ensuring you are always internal audit and inspection-ready. 

IGOR's sample repositories are fully customizable to your company's needs, perfectly accompanying the custom storage locations that you can create in the system. Track parent-child relationships of your samples to trace their lineage, and conveniently view the "family tree" of each biospecimen at any given time. What's more, IGOR automatically maintains meticulous records of all sample-related activities for you.

With IGOR's electronic lab notebook, you can seamlessly document the usage of biospecimen for your experiments, as well as all related processing activities. Directly link these activities to your experimental protocols and accurately record any deviations from standard procedures in real time. Combined with comprehensive audit trails and version control of notebook entries and data files, this ensures full transparency and creates a detailed audit trail that not only simplifies compliance but also reinforces the credibility of your research. 

Thanks to IGOR's dedicated SOP management tool, which streamlines the creation, review, approval, and sharing of standard operating procedures, you can standardize experimental processes across your team and ensure they are thoroughly documented. This of course also applies to procedures detailing the handling, storage, and disposal of human tissues. 

Data security is crucial when handling sensitive human tissue samples. IGOR allows you to restrict access to sensitive human tissue sample information and prevent unauthorized access. Through the 'Teams' dashboard, you can define custom user roles and fine-tune access permissions, ensuring compliance and preventing unauthorized access to your sensitive data.

 

From their creation to their use in experiments and eventual disposal, IGOR meticulously records every detail of the lifecycle of human tissue samples in your care. This thorough tracking makes IGOR an indispensable tool for research organizations striving to achieve and maintain high standards of compliance and operational excellence. 

Standardize your data capture for quality assurance

Ensure good laboratory (GLP) and good manufacturing practices (GMP) by streamlining your work processes and standardizing your data capture. IGOR's Template Generator is an invaluable tool for scientists aiming to optimize their workflows by pre-formatting commonly used documents for experiment documentation. These templates not only save considerable time when running your experiments but also ensure consistency in the information recorded by all team members. An added bonus is that standardized processes and data capture help improve reproducibility of research results across the whole organization.

IGOR’s Template Generator and SOP Management feature - A powerful combination to standardize your data capture, boost your QA, and improve reproducibility of research results across the whole organization!

Standard Operating Procedures (SOPs) and IGOR

SOPs are a cornerstone of quality management and efficient operations for life science and biotech companies. And they are required documents under both good laboratory practices (GLP) and good manufacturing practices (GMP), making them particularly relevant for research teams in FDA-regulated industries.

IGOR was designed to make it easier for you and your team to create, review, approve, share, enforce, track, and archive your organization's SOPs. And here is how:

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When a scientist uses an SOP for an experiment, IGOR attaches a copy of the document to the respective lab notebook entry. This serves 2 purposes:

1) It is always clear which version of the document was used for a particular experiment. This is particularly useful in identifying SOPs when reviewing historical data. 

2) While the master file is locked to prevent edits, the copy attached to lab notebook entries can be edited, with the changes tracked for audit purposes. This allows the researcher to document any protocol deviations straight away.

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