Compliance
Compliance built into the platform, not bolted on
HDLIMS was designed for regulated laboratories from the start. Audit trails, electronic signatures, access control and data integrity controls are part of the core platform, and every release comes with the documentation your validation team needs.
Frameworks
Designed to support the regulations your lab works under
One platform, configured for the requirements of GxP, clinical, ISO-accredited and food safety laboratories.
21 CFR Part 11
US FDA requirements for electronic records and electronic signatures in GxP environments.
EU GMP Annex 11
European expectations for computerized systems used in GMP-regulated activities.
GAMP 5 & CSA
Risk-based computerized system validation and FDA’s computer software assurance approach.
ALCOA+ data integrity
Data that is attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available.
ISO/IEC 17025
Competence, impartiality and consistent operation of testing and calibration laboratories.
ISO 15189, CLIA & CAP
Quality and competence requirements for medical and clinical laboratories.
GLP
Good Laboratory Practice under 21 CFR Part 58 and the OECD Principles of GLP.
HIPAA & GDPR
Protection of patient health information and personal data, with privacy by design.
ISO 20387
General requirements for biobanking, including traceability and sample quality.
FSMA, ISO 22000 & GFSI
Food safety testing, traceability and supplier verification requirements.
EU GMP Annex 1
Contamination control and environmental monitoring for sterile manufacturing.
TNI & EPA methods
Environmental laboratory accreditation, QC batches and method compliance.
21 CFR Part 11 & Annex 11
How HDLIMS addresses Part 11 technical controls
A summary of the technical controls HDLIMS provides. Procedural controls, such as §11.10(j) accountability policies, remain with your organization.
| Section | Requirement | How HDLIMS supports it |
|---|---|---|
| §11.10(a) | System validation | Vendor validation package, release testing evidence and traceability to support your validation. |
| §11.10(b) | Accurate and complete copies | Human-readable and electronic export of records, including metadata and audit trail. |
| §11.10(c) | Record protection | Retention policies, archiving and protection against deletion for the full retention period. |
| §11.10(d) | Limited system access | Role-based access control, single sign-on and multi-factor authentication. |
| §11.10(e) | Audit trails | Secure, computer-generated, time-stamped audit trails that record who, what, when and why, and cannot be disabled. |
| §11.10(f) | Operational checks | Workflow sequencing that enforces the permitted order of steps and events. |
| §11.10(g) | Authority checks | Permissions evaluated per action, record and site before any create, modify or sign operation. |
| §11.10(h) | Device checks | Instrument and terminal identification recorded with captured data. |
| §11.10(i) | Training | Training and qualification records, enforced before users can perform restricted tasks. |
| §11.10(k) | Documentation controls | Controlled system documentation, release notes and configuration change history. |
| §11.50 | Signature manifestations | Signed records display the printed name, date and time, and meaning of each signature. |
| §11.70 | Signature/record linking | Signatures are bound to the specific version of the record and cannot be copied or transferred. |
| §11.200 | Signature components | Two distinct identification components with re-authentication at signing. |
| §11.300 | Identification codes and passwords | Password policies, expiry, lockout and attempted-misuse reporting, or delegation to your identity provider. |
Read our 21 CFR Part 11 checklist for LIMS for a detailed explanation of each requirement.
Data integrity
ALCOA+ as a property of the system
Data integrity failures usually trace back to systems that allow them. HDLIMS removes the opportunities.
Attributable
Unique user accounts, SSO and instrument IDs on every entry
Legible
Structured data, readable for the full retention period
Contemporaneous
Server time stamps and capture at the point of work
Original
Raw data preserved and linked via the SDMS
Accurate
Direct instrument capture and in-system calculations
Complete
No hidden deletions; every change in the audit trail
Consistent
Enforced sequence of steps and synchronized time
Enduring
Durable storage with integrity verification
Available
Records retrievable in seconds for review and inspection
Validation accelerator
Validate in a fraction of the effort
Every HDLIMS release includes a validation package aligned with GAMP 5 Second Edition and FDA’s computer software assurance principles, so your team builds on our evidence instead of recreating it.
Requirements and specifications
Functional and design specifications for each release, ready to reference in your validation plan.
Risk assessment
Function-level risk assessment to help you focus verification effort where it matters.
Executed test evidence
Our test protocols and results for each release, so you do not repeat vendor testing.
Traceability matrix
Requirements traced to tests, ready to extend with your configuration-specific verification.
Templates
Templates for validation plans, user requirements, configuration verification and summary reports.
Release impact reports
Change descriptions and impact assessments for every release to streamline upgrade validation.
Shared responsibility
Clear roles between HDLIMS and your quality team
Compliance is a partnership. Here is how responsibilities are typically divided for HDLIMS Cloud.
HDLIMS is responsible for
- Design and develop HDLIMS under a documented quality management system
- Build Part 11 and Annex 11 technical controls into the platform
- Test each release and provide the evidence in the validation package
- Operate, monitor and back up HDLIMS Cloud environments
- Notify customers of changes and provide release documentation in advance
Your organization is responsible for
- Define intended use, user requirements and risk assessment
- Verify your configuration, workflows and integrations
- Maintain procedural controls: SOPs, training and periodic review
- Administer users, roles and electronic signature policies
- Decide on release adoption through your change control process
FAQ
Compliance questions
Is HDLIMS “21 CFR Part 11 compliant”?
Do we still need to validate HDLIMS?
How are upgrades handled in a validated environment?
Can we audit HDLIMS as a supplier?
Talk to our compliance specialists
Walk through audit trails, electronic signatures and our validation package with a specialist who has worked in regulated labs.