30 controls
43 frameworks share controls with it
United States
verified against its source document
Every control below is one this framework asks for. The right hand column counts how
many other frameworks in our corpus carry the same control, which is the difference between
doing this work once and doing it again for the next standard.
21 CFR Part 58 Good Laboratory Practice Evidence & Implementation Kit
30 controls is the documentation set somebody has to write. This is that set,
already written: an adopt-ready artifact for every control in policy and procedure text you
edit rather than draft, and the evidence checklist an auditor asks for against each.
See what is in it, $249
The same set every buyer of this kit receives. Nothing here is produced on request.
What you already have
Frameworks whose controls overlap this one, most first. If you run any of them, the
count is roughly what you have already evidenced.
Every control
| Code | Control | Also in |
|---|
21CFR58-58.217 | Suspension or Termination of a Testing Facility by a Sponsor | 0 |
58.10 | Applicability to Grants and Contracts | 0 |
58.105 | Test and Control Article Characterization | 1 |
58.107 | Test and Control Article Handling | 1 |
58.113 | Mixtures of Articles with Carriers | 0 |
58.120 | Protocol | 1 |
58.130 | Conduct of a Nonclinical Laboratory Study | 1 |
58.15 | Inspection of Testing Facility | 1 |
58.185 | Reporting of Nonclinical Laboratory Study Results | 1 |
58.190 | Storage and Retrieval of Records and Data | 1 |
58.195 | Retention of Records | 1 |
58.200 | Purpose of Disqualification | 0 |
58.202 | Grounds for Disqualification | 0 |
58.206 | Final Order on Disqualification | 0 |
58.219 | Reinstatement of Disqualified Facility | 0 |
58.29 | Personnel | 2 |
58.31 | Testing Facility Management | 1 |
58.33 | Study Director | 1 |
58.35 | Quality Assurance Unit | 1 |
58.41 | General Facility Requirements | 1 |
58.43 | Animal Care Facilities | 27 |
58.45 | Animal Supply Facilities | 0 |
58.47 | Laboratory Operation Areas | 1 |
58.49 | Laboratory Operation Areas | 16 |
58.51 | Specimen and Data Storage Facilities | 1 |
58.61 | Equipment Design | 1 |
58.63 | Maintenance and Calibration of Equipment | 1 |
58.81 | Standard Operating Procedures | 1 |
58.83 | Reagents and Solutions | 1 |
58.90 | Animal Care | 0 |
Tell me when 21 CFR Part 58 files something new
One email when a public company newly discloses something this framework governs, naming the company and what our corpus says it puts in scope. Nothing else, and one click to stop.
What this page is
A control-level reference for 21 CFR Part 58, drawn from our framework corpus. Control codes and
titles are references to the standard, not reproductions of it. The overlap counts and the
auditor artefacts are our own work and are the part you will not find elsewhere.
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