Laboratory Systems Compliance
Laboratory Information Management (LIMS) software systems provide significant benefits to Life Sciences companies by improving efficiency, ensuring compliance and enhancing data management capabilities. Laboratories routinely process hundreds of samples daily using increasingly complex technologies that generate large volumes of data that attest to the quality, efficacy and safety of drugs, devices and therapeutics treatments. Consequently, laboratory systems must ensure data integrity, traceability, auditability and reliability of test results.
Laboratory systems compliance is the assurance that policies, procedures and practices are in place to meet industry standards and governing agencies to include the US Food and Drug Administration (FDA), UK Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA) and other international organizations.
Life Science companies are looking to technology providers for greater laboratory automation and laboratory informatics to improve data integrity and reduce risk, increase laboratory capacity with shortened processing times, and act as an enabler for integrated smart laboratories designed to facilitate connectivity, data sharing, and interaction with other company systems.
Laboratory Ecosystem
Key Features of LIMS
- Sample Management – comprehensive tracking of samples to include accessioning, labeling, storage and retrieval. Each sample is assigned a unique identifier that maintains detailed records.
- Data Management – consolidates laboratory data from various sources, ensuring data integrity, security and accessibility.
- Workflow Automation – automation of laboratory workflows by defining and enforcing standard operating procedures (SOPs) for sample processing and testing
- Instrument Integration – integration of instruments to facilitate seamless data exchange, thus reducing manual data entry and transcription errors.
- Inventory Management – tracking of reagents and consumables, recording expiration dates and managing stock levels to ensure availability of necessary materials.
- Electronic Laboratory Notebooks (ELN) – software designed to document research, experiments and procedures performed in the laboratory.
Arbour Group Compliance Expertise
Arbour Group can provide a holistic and cost-effective approach to achieving and maintaining laboratory systems compliance. We have the expertise to perform validation testing that ensures systems work as intended as well as develop associated SOPs that provide the guidance necessary to maintain systems as required in the regulated Life Sciences industry.
Our validation deliverables include:
- Validation Plan
- User Requirements/Functional Specifications (URFS)
- IQ/OQ/PQ Test Protocol Development & Execution
- Requirements Traceability Matrix
- Validation Summary Report
We can also assist with development and/or updating critical procedures to include:
- Software Development Life Cycle (SDLC)
- IT Data Integrity
- Backup/Recovery
- Security Administration
- Operations & Maintenance
- Change Control
- Disaster Recovery Planning
- Periodic Review
- Supplier Audit
Arbour Group compliance services include:
- Knowledgeable software testing expertise
- Hands-on experience with regulatory agency requirements and expectations
- Proven and reviewed methodologies and practices
- Dedicated global testing centers
- Warranted validation deliverables
For over 25 years, Arbour Group has been providing the expertise and tools to life science organizations to assess, optimize and ensure Laboratory System compliance.
Speak with our experts. Arbour Group will help bring clarity to your business compliance needs.
Frequently Asked Questions
- Why is laboratory systems compliance important?
Laboratory systems software attests to the quality, efficacy and safety of pharmaceuticals, medical devices and biologics as evidenced by laboratory test results. Laboratory software has to be validated for its intended (configured) uses to comply with FDA 21 CFR Part 11 and other applicable requirements.
- What steps are involved in laboratory software validation?
Validation of laboratory software systems includes development of documentation that includes authoring a validation plan, development of regulatory requirements, testing requirements and summarizing results.
- What regulatory bodies require compliance for laboratory systems?
The US Food and Drug Administration (FDA) requires all software systems containing quality records develop appropriate validation documentation. Also, there are similar regulatory requirements for other international agencies such as the UK Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA).
- What is the best practice for maintaining laboratory system validation on an ongoing basis?
Written procedures must be in place that provide adequate control over system changes. A Change Control procedure must be followed that identifies and evaluates changes for impact to the validated system and tests updated and/or new functionality to demonstrate that the integrity of the software remains intact.
- How can Arbour Group help with laboratory software validation and compliance?
Arbour Group has significant experience and deep expertise related to the requirements of the US and international regulatory agencies. We understand the regulatory citations and their interpretation as it related to development of a culture of compliance