On-Site Risk Assessment

Do You Know the Gaps in Your Laboratory’s Processes?

Through our On-Site Risk Assessment Service, we can help you to identify opportunities for improvement in your procedures, training, and validation processes. Performing an On-Site Risk Assessment with Life Technologies helps you prepare for inspection and peace of mind that your laboratory is running at top productivity levels.

“Our Method is Validated; Isn't That Enough?”

System accuracy and precision are made up of instrument population,
software version, sample prep, test methods, and lab personnel
 

 

If you are a publicly traded company, you may fall under heavier scrutiny than a privately held company, and any adverse occurrence related to regulatory compliance or inspection would likely have a significant negative impact on investor and market confidence that could ultimately lower the company value (stock prices).

If you are a company in regulated industry (e.g., pharmaceuticals, clinical diagnostics, and forensics), you may be subject to regulations from bodies such as the FDA, CLIA, etc. that have specific requirements. This regulatory rigor could often extend to institutions or laboratories that partner or provide services to companies in more formalized, regulated industries, making those institutions or laboratories expose to inspection by the same regulatory agencies.
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What are Qualification and Validation?

Analytical Instrument Qualification   Computer System Qualification

Non-method specific test(s) based upon accepted parameters such as:

  • Precision
  • Detector linearity
  • Accuracy
  • Temperature accuracy and linearity
  

System tests based upon laboratory requirements such as:

  • Security settings
  • Audit trails
  • User/System configuration
  • Change control
  • User training

 

If you are a company that relies on electronic records for certain parts of your workflow (such as between the acquisition of data from an instrument and processing the data), your systems may be subject to the requirements and limitations of 21 CFR Part 11, Electronic Records; Electronic Signatures, or other industry best practices. For companies outside the pharmaceutical and biotech area, there could also be increasing ISO and clinical standards requirements requiring computer system validation to verify that electronic records are controlled and unadulterated.

What is Included in the Assessment?

Life Technologies will assist your staff to determine the degree to which your laboratory’s systems and processes conform to current, applicable regulations and industry best practices.

Risk Assement Service

Professional service helping prevent audit failures
  • Performed by Life Technologies trained-and-certified representatives
  • Helps determine the degree to which you comply with applicable regulations
  • Assists in formulating an action plan to enable you to achieve a higher degree of compliance

Assesses

  • Procedural controls
  • Facilities, equipment, and computer security
  • Employee training and qualifications
  • System validation
  • Change management/change control
  • Document control
  • Part 11 compliance
  • Qualifications and CSV procedures

 

  • Identification of opportunities to help improve the degree of compliance of your systems and processes
  • Identification of opportunities to streamline policies and procedures to help improve productivity and lower operating costs
  • Formulation of an action plan to enable you to achieve a high level of compliance and efficiency (learn more about Computer System Validation)

During the On-Site Risk Assessment, your Life Technologies™ representative will assist you to review all Life Technologies™ systems for:

  • Procedural controls (Standard Operating Procedures)
    • Company operations and responsibilities
    • Physical access control
    • Electronic access control
    • Data protection
    • Data management
    • Training
    • Change control
    • Document control
    • System and facility maintenance
    • Instrument qualification
    • Validation of computerized systems
  • Facilities, equipment, and computer security
  • Employee training and qualifications
  • System validation
    • Network qualification
    • Instrument IQ/OQ
    • Instrument preventive maintenance, tuning, and calibration
    • Software validation
  • Change management (Change control)
  • Document control
  • 21 CFR Part 11 applicability/compliance
    • Electronic records
    • Electronic signatures
    • Audit trails
  • Instrument qualification and computer system validation

An On-Site Risk Assessment can either be performed separately or included as part of a Computer System Validation engagement.

To speak with our team about the On-Site Risk Assessment service for your laboratory, please contact one of our sales representatives at complianceservices@lifetech.com.

Customer has the sole responsibility to ensure that Life Technologies and/or its affiliate(s) products and services, including but not limited to qualification and validation, are adequate to meet customer’s own regulation, certification and other requirements.

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