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5416 East Baseline Road, Suite 120, Mesa, AZ 85206 Phone: (480) 8327373 or (877) 6601IRB Fax: (480) 8327376 www.compassirb.com Protocol Deviation Report Form Instructions: Please read and complete.

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Deviation Handling As a part of Corrective and Preventive action (CAPA), if the deviation is once detected, then it needs immediate action (i.e., corrections), the root cause analysis should be done and systemic actions need to be implemented (i.e., corrective actions) to prevent non-conformances in the future.

Deviation Report means a report used to obtain approvals to temporarily modify or to document exceptions to usual operating, Manufacturing, packaging, testing instructions, test results or procedures.

When to raise a deviation: As soon a deviation occurs it should be immediately reported to Quality assurance (QA) within one working day from the time when the deviation has occurred or as per the Standard operating procedure (SOP).

In the context of AWO (Advanced Warehouse Operations) a Deviation is a process that happens within the generation of a Task to swap the initial Routing assigned to the Task being generated with a different one, based on the Warehouse definition.

A deviation report is a real-time recording of a deviation. It will contain the investigations of the root-cause analysis and the implemented corrective and preventive actions. Deviation reports are mandated for compliance with cGMP.

Anyone in the company can initiate a deviation report, but it is usually done by the responsible department. The deviation will be reported, up to 1 day after the discovery. It is necessary to be as clear and accurate as possible in the details provided when reporting a non-conformance to aid the investigation.

Description of the deviation: Include the who, where, what, when details in this section. Be specific, give exact and precise data. Do not attempt to give the “why” answer in this section. Detail only facts, data or observations prior to, during and/or after the event.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232