Compliance Built Into Your Daily Workflow
Not bolted on as an afterthought. Every record is audit-ready from the moment it is created. When the auditor walks in, your documentation is already complete.
Audit-Ready From Day One
The biggest compliance headache is not the audit itself. It is the scramble to assemble documentation that should have been captured all along. The ELN Suite eliminates that scramble by recording every action automatically as part of your team's normal workflow.
Every experiment entry, every edit, every review, and every approval is timestamped and attributed to a specific user. Version history preserves the complete lifecycle of each record, including what changed, who changed it, and when. Structured workflows ensure that required steps like peer review and PI sign-off actually happen before work moves forward.
Electronic signatures with meaning statements (authored, reviewed, approved) satisfy the strictest regulatory expectations. When an inspector asks for documentation, your team can pull up a complete, tamper-evident record in seconds rather than spending days reconstructing it from scattered files.
Audit Trail Preview
Signer Identification
Unique user credentials tied to an individual, never shared accounts
Authentication
Credential verification at the moment of signing with session controls
Non-Repudiation
Bound to the specific record version so signatures cannot be copied or reapplied
Meaning Statement
Signer selects authored, reviewed, or approved to document intent
Electronic Signatures That Satisfy Regulators
An electronic signature is only as good as the controls around it. The ELN Suite implements electronic signatures that meet the requirements of FDA 21 CFR Part 11, including unique signer identification, authentication at the time of signing, and binding of the signature to the specific record version.
Each time a user signs a record, they authenticate with their credentials and select a meaning statement that documents their intent. The system enforces that signatures cannot be copied, transferred, or reapplied to a different record. If the underlying data changes after signing, the signature is invalidated and a new signing event is required.
Every signature event is captured in the audit trail with the signer identity, timestamp, meaning statement, and record version. This creates the kind of defensible, traceable documentation that auditors look for and that protects your lab if questions arise months or years later.
Regulatory Framework Support
Different labs operate under different regulatory frameworks, and many labs operate under several at once. The ELN Suite provides the technical controls that span all major laboratory regulations, so you do not need to maintain separate systems for different compliance requirements.
Whether your lab follows FDA guidelines, GLP/GMP standards, ISO accreditation requirements, or ALCOA+ data integrity principles, the same audit trails, electronic signatures, access controls, and version management features support your compliance posture. LabLynx has 25 years of experience helping regulated labs meet these standards, and that experience is built into every workflow.
FDA 21 CFR Part 11
Electronic records and electronic signatures for regulated industries
GLP
Good Laboratory Practice for non-clinical safety studies
GMP
Good Manufacturing Practice for production and quality control
ISO 17025
General requirements for the competence of testing and calibration laboratories
ALCOA+
Data integrity framework ensuring records are Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available
EU Annex 11
European requirements for computerized systems in GMP-regulated environments
Single Sign-On and Access Control
Managing separate credentials for every lab system creates friction for users and risk for IT. The ELN Suite integrates with your organization's identity provider through SAML 2.0, LDAP, or Active Directory, so your team logs in with the credentials they already use.
When someone joins or leaves the organization, IT updates access in one place and the change propagates to the ELN Suite automatically. This eliminates orphaned accounts and ensures that former employees lose access the moment they are offboarded. Multi-factor authentication adds another layer of protection for sensitive data.
Inside the platform, role-based access control determines what each user can see and do. Administrators define roles at the organization, department, or project level. You can restrict access to specific experiments, limit export capabilities, or require additional authentication for sensitive operations.
SAML 2.0
Integrate with Okta, Azure AD, OneLogin, and other SAML providers
LDAP
Connect to your on-premises directory service for centralized authentication
Active Directory
Native integration with Microsoft Active Directory environments
MFA
Multi-factor authentication with TOTP, push notifications, or hardware keys
AES-256 Encryption at Rest
All stored data is encrypted using the same standard trusted by government agencies
TLS 1.2+ in Transit
Every connection between your browser and the platform is encrypted end to end
Role-Based Access Control
Users only access the data their role permits, down to the experiment level
Immutable Audit Trail
Every access event is logged and cannot be modified or deleted by anyone
SOC 2 Compliant Hosting
Your data resides in data centers that meet SOC 2 Type II requirements
Encryption and Data Protection
Lab data includes proprietary research, patient information, and intellectual property that cannot afford to be compromised. The ELN Suite protects your data with AES-256 encryption at rest and TLS 1.2 or higher for every connection in transit. These are the same encryption standards used by financial institutions and government agencies.
Role-based access control ensures that encryption is just one layer of a defense-in-depth approach. Even within the platform, users only see and interact with the data their role permits. Sensitive experiments can be restricted to specific individuals, and export permissions can be controlled independently from viewing permissions.
The complete audit trail records every data access event, not just modifications. You can see who viewed a record, when they viewed it, and from where. Combined with encrypted backups and SOC 2 compliant hosting infrastructure, the ELN Suite provides the layered security that modern labs require.
Frequently Asked Questions
Is the ELN Suite validated for FDA 21 CFR Part 11?
Yes. The ELN Suite includes the technical controls required by 21 CFR Part 11: audit trails, electronic signatures with signer authentication, automatic timestamping, and access controls. LabLynx also provides IQ/OQ documentation to support your validation process.
How do electronic signatures work?
Each signature requires the signer to authenticate with their credentials and select a meaning statement (such as authored, reviewed, or approved). The signature is bound to the record and cannot be reused or transferred. A full log of every signature event is maintained in the audit trail.
What audit trail information is captured?
The system records who performed an action, what was changed, the before and after values, a timestamp, and the reason for the change when applicable. Audit trail entries are immutable and cannot be modified or deleted by any user, including administrators.
Does the system support ALCOA+ data integrity?
Every record in the ELN Suite is automatically Attributable, Legible, Contemporaneous, Original, and Accurate. The plus attributes (Complete, Consistent, Enduring, and Available) are enforced through structured data entry, version control, and reliable cloud hosting.
Can we integrate with our existing identity provider?
Yes. The ELN Suite supports SAML 2.0, LDAP, and Active Directory for single sign-on. This means your team uses their existing credentials, and your IT team manages access from one place. Multi-factor authentication is also available.
How is data encrypted?
Data is encrypted at rest using AES-256 and in transit using TLS 1.2 or higher. Backups are encrypted with the same standard. Your data resides in SOC 2 compliant data centers with geographic redundancy.
Make your lab audit-ready
See how the ELN Suite builds compliance into your everyday workflows.