Quality Management System

GLP/GMP compliant for regulatory grade services. Quality systems that govern the execution of every project.

ACGT pursues a culture of quality with an aim towards continuous improvement. Our rigorous quality management systems (QMS) ensure compliance with Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP) sequence analysis in regulatory grade sequencing and molecular biology studies.

Features

GLP and cGMP regulatory compliance in sample sequence analysis
Independent QAU personnel to ensure regulatory compliance in GLP studies and cGMP tests
Vendor, service provider and equipment qualification programs
Laboratory personnel GLP and cGMP training programs

Corrective Action/Preventative Action (CAPA) system including incident and out-of-specification (OOS) reporting
Documented change control and review program
Routine internal quality audits and in-process audits in regulatory grade studies
DEA licensed for Schedule I controlled substances and List I chemicals

Research & Regulatory Levels

Standard Research Testing: Every custom research-grade project is initiated with a written proposal detailing the test methods used, a description of deliverables upon study completion with an estimated timetable and pricing. While the study is in process, you can expect to receive real-time updates and close communication with your study manager. At its conclusion, a report detailing the analysis results is provided along with raw data. Your raw project data is stored onsite for 6 months before it is discarded.

GLP: Fully compliant with GLP standards pursuant to 40 CFR Part 160 or 21 CFR Part 58, including chain of custody, in-process auditing, compliance statements, and archiving. At the conclusion of your GLP study, a final report is provided detailing the instrument, reagents, testing procedure and methods used along with your data analysis results; deliverables include all raw data. All electronic records, including raw data and analysis files, are archived onsite for ten years.

cGMP: Fully compliant with cGMP standards and practices under 21 CFR Parts 210 and 211 as they relate to the confirmation of the test article DNA sequence identity. Our cGMP service requires Method Development and a GLP level validation of Testing Method for each particular test article type. A written Quality Agreement between ACGT and its regulatory clientele initiates our cGMP service detailing all aspects of testing and deliverables. At the conclusion of the cGMP study, you can expect to receive ACGT’s Certificate of Testing along with your data analysis report and raw data. All electronic records, including raw data and analysis files, are archived onsite for ten years.

Clinical: Fully compliant with state CLIA standards for clinical-grade sequencing. Laboratory Developed Tests or LDTs can be designed, validated and implemented at the customer’s request. ACGT can also provide components of clinical testing as a service lab with the requesting organization accepting a test provider role (i.e., recruiting patients, collecting samples, issuing clinical reports, etc.). The final test would be placed on the customer’s CLIA menu including the sign-off by their Clinical Director of all reports issued to patients.

Invitation to Audit

Current and prospective clients interested in regulatory grade GLP or cGMP sequencing, please contact us to schedule an onsite audit or technical visit.