CAP Accreditation Success: How GRCF Achieved Excellence
The GRCF Biorepository at Johns Hopkins, managing up to 1 million vials and serving ~300 investigators, became the 12th CAP-accredited biorepository in the U.S.
Freezerworks handled every data management requirement the inspectors checked: audit trails, permissions, spot checks, and validated software updates. All 30 spot checks passed.
“Freezerworks was probably our easiest part of the CAP process. As we were going through the CAP inspection and checklist, everything we needed to be able to do was already written into the program.”
About the GRCF at Johns Hopkins
The Genetic Resources Core Facility (GRCF) Biorepository & Cell Center at the Johns Hopkins School of Medicine was established in 1989 by Dr. Margaret Penno to produce immortalized cell lines from human blood. Today it serves as both an on-site biorepository and a bioprocessing center, specializing in mammalian cell culture propagation, primary cell establishment, lymphocyte isolation, and LCL establishment.
The facility has processed more than 25,000 blood specimens, serves approximately 300 investigators at Johns Hopkins and beyond, and stores up to 1 million vials. In 2011, the GRCF installed Freezerworks to manage its biorepository data. A year later, under Director Melissa Olson, PhD, the facility undertook the rigorous process of CAP biorepository accreditation, becoming the 12th CAP-accredited biorepository in the United States.
THE SITUATION
The CAP accreditation program for biorepositories launched in 2012. Dr. Olson describes the path to accreditation as a “major reorganizational effort”. One that examines every aspect of biobank operations. To pass, the GRCF had to demonstrate rigorous compliance across four critical areas:
CAP requires a fully functioning LIMS as a core component of accreditation. Every data function the inspectors might test (search, location, history) had to work flawlessly on the day of inspection.
CAP inspectors scrutinized both physical sample security (freezer locks, temperature alarms, environmental monitoring) and data security (restricted permissions, intrusion protection, and a complete record of every change to every sample record).
Inspectors approached any staff member at any time and requested a random sample be located. Every person on the lab floor had to be able to find any specimen quickly and confirm it matched the Freezerworks inventory record.
CAP requires proof that software updates have been validated and that no release has adversely affected existing inventory data, with a specific validation statement required for every update, per FDA General Principles of Software Validation.
OUR SOLUTIONS
The GRCF installed Freezerworks in 2011. When CAP accreditation inspectors arrived, every requirement on their checklist was already built into the system, and every staff member could demonstrate it in real time.
Specimen & Data Security, Built In
CAP’s approach is to protect the specimen at every stage, from physical storage conditions to the integrity of its data record. Freezerworks satisfied both dimensions on the day of inspection:
- Full audit trail: Every change to every sample record is logged and traceable. Inspectors confirmed that the life of each vial could be followed from collection to final disposition.
- Hierarchical permissions: A defined population of users was shown to CAP inspectors, some with full modification rights, others as read-only, based on structural roles within the facility.
- No data ever fully deleted: When a vial leaves the biorepository, its position information is removed, but all collected specimen data is permanently retained. A point of pride the GRCF shared directly with inspectors.
- External intrusion protection: Inspectors verified that the software protecting sample data was secured against unauthorized external access.
“The audit trail was really critical to CAP, and something they took great interest in seeing. We were able to demonstrate to their satisfaction that every change made was traceable through an audit trail.” — Melissa Olson, PhD, Director, GRCF
30 Spot Checks — 30 Successes
CAP inspectors tested the system by approaching any staff member at random and requesting a live sample retrieval. Because the entire team had been trained on Freezerworks and used it daily, every query was answered confidently and quickly.
- Inspectors asked staff to locate a specific sample and identify the sample beside it, then confirm it matched the Freezerworks record
- The GRCF performs 30 random spot checks weekly as standard quality control. A practice the inspectors joined in on during the audit
- All 30 spot checks were passed with zero discrepancies
Validated Software Updates
CAP requires documentation that every software update to the LIMS has been validated and that no release has adversely affected existing inventory data. Freezerworks provided a specific validation statement with every update, in compliance with the FDA General Principles of Software Validation.
- Every Freezerworks update is validated per FDA General Principles of Software Validation
- A specific validation statement accompanies each release confirming no changes will affect current inventory data
- Certification statements are available on our site our site
“Whether the bank is for managing samples for clinical trials, for general population or disease specific studies, academic or industry, what CAP accreditation can do is help develop common standards in this environment that will raise the quality for everyone and ultimately the end-user.” — Barbara Glazer, Former CAP Biorepository Inspector
THE OUTCOMES
CAP accreditation is not the end; it is the beginning of an ongoing re-assessment cycle. For GRCF, Freezerworks provides the foundation for continuous quality management that CAP requires: from formalized SOPs to quantifiable quality incident tracking to re-inspection readiness at any time.
12th CAP-Accredited Biorepository
GRCF joined a small group of the most rigorously vetted biorepositories in the United States.
30 / 30 Spot Checks Passed
Every live inspector spot check passed with zero discrepancies. A direct result of daily Freezerworks use by all staff.
Full Audit Trail Compliance
Every sample change is traceable, every permission is defined, and no data is ever fully deleted. Exactly as CAP requires.
1 Million Vials Under Management
Freezerworks manages up to 1 million vials across a biorepository serving ~300 investigators at Johns Hopkins and beyond.
Ready to see how we can help your lab?
Whether you’re pursuing CAP accreditation or need a validated, reliable sample management system, Freezerworks has you covered.
