Laboratory Compliance

Total Quality Solution for Laboratory Assets

Sequence’s Laboratory Compliance Services (LCS) division offers a total quality solution for your laboratory allowing your scientists and analysts to focus on the science your business relies on.

Whether its is a new facility start-up, remediation project, or process improvement, Sequence can develop and implement a customized, quality-minded asset management program. Sequence can also provide staffing offsite or onsite for program management depending on client need or asset volume.

Laboratory Compliance Solutions:

Asset Management
  • Tagging each asset with unique identifier

  • Creation of manual or electronic asset folders (asset birth certificate, operation manual, calibration certificates, software)
  • Inventory management (client’s software or Sequence’s software solution)
  • Manage change control process for implementation of or changes to laboratory assets
  • Vendor management (for all; installations, calibrations, maintenance, and services)
Validation, Re-Qualification, Addenda and Periodic Reviews
  • Author, develop, and revise laboratory asset validation program (suite of SOPs)
  • Validate all instrumentation and equipment for the laboratory
  • Re-qualify all chambers, autoclaves, washers, etc. based on the established frequency
  • Validation addenda
  • Method validations
  • Establish a periodic review process for critical assets
Administration of Laboratory Assets and Data Integrity Assurance
  • Administrator for all laboratory firmware & software
  • Manage data integrity workflows
  • Author administrative SOPs
  • Creation of new users
  • Archival of data for manual data dumps (if required)
  • Periodic audit trail archival for laboratory software
Calibration and Preventive Maintenance
  • Manage calibration and maintenance process for all laboratory assets
  • Establish calibration and PM frequency
  • Label all assets with universal calibration sticker
  • Establish out-of-service process and tagging procedure
  • Perform majority of laboratory asset calibrations and PMs
  • Manage outsourced third-party calibrations (standards & unique calibrations)
  • Manage manufacturer service personnel for proprietary instrumentation and equipment service agreements
Laboratory Supplies Inventory Management and Purchasing
  • On or offsite purchasing agent (based on need)
  • Manage inventory levels of common laboratory consumables
  • Manage requests for all laboratory consumable purchases
Additional Services
  • Laboratory Validation & Program Development
  • Method Validation & Program Development
  • Staff Augmentation of Laboratory Management and Validation Personnel
  • Strategic partners within the following laboratory software: LIMS, Electronic Notebook, Document Management, Calibration Management Software
  • Laboratory Audits for cGxP or ISO
  • Laboratory Quality Assurance Support
  • Computer System Validation (CSV)
  • 483 and Warning Letter Remediation
  • Calibration Program Development
  • Microbiology Testing at Sequence’s headquarters in Raleigh, North Carolina
  • Data Integrity Assessment

 “Sequence has been, withoua shadow of a doubt, the most customer-centered company with whom I have ever had the pleasure to work.”  – Director, LinkedIn

“Compliance and Data is critical to our business.  Sequence understands that the right data management solution must fit our business needs as well as our compliance strategy.” – Sr. Manager, LinkedIn

  Sequence took our vision and with the most amazing teamwork strategies I have ever witnessed turned it into a viable reality.” – Sr. Manager, LinkedIn

“Thank you for the amazing efforts of your most innovative and hardworking staff.” – VP, LinkedIn