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Sub System /
Computer System Validation
Computer System Validation
View Detailed Analysis

Analytics Overview

17
Form 483s Issued
2
483s converted to WL
17
Total Observation
Form 483s Issued
+74 from last period

Analytics Overview

Form 483 Conversion Rate by Year
Form 483s Issued (Yearly)

Recent Form 483s & Warning Letters

View all 483’s
Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
06 Jan 2025
Suzhou Suncadia Biopharmaceuticals Co. Ltd.
Drugs
View Form 483
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
View Form 483
07 Jun 2024
Frederick Manufacturing Center
Drugs
View Form 483
23 Apr 2024
Zydus Lifesciences Limited
Drugs
View Form 483
View Warning Letter
01 Mar 2024
Amphastar Pharmaceuticals, Inc.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Arsen Karapetyan
3
0
Camerson E Moore
2
0
Yasamin Ameri
2
0
Andrew 'Drew' Haack, PhD
1
0
Brian Janelsins, PhD
1
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Automatic or electronic equipment, including computers or related systems, are not routinely calibrated, inspected, or checked according to written programs
Suzhou Suncadia Biopharmaceuticals Co. Ltd.		 06 Jan 2025 Normal Justification: Computer System Validation is implicated as documentation and maintenance of SCADA software validation were inadequate.
Excerpt: SCADA software validation requirements are not documented, maintained, and updated.
View Details
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Exela Pharma Sciences LLC		 15 Nov 2024 Normal Justification: The use of non-validated Excel workbooks for stability sample inventory and defect data management presents significant risks to data integrity, violating regulatory expectations.
Excerpt: Your firm uses a non-validated system (Excel workbooks) to manage the stability samples inventory.
View Details
Analytical instruments in support of manufacture are not adequately controlled in assurance of data integrity
Frederick Manufacturing Center		 07 Jun 2024 Normal Justification: Computer system validation ensures that computerized systems function as intended, including audit trail mechanisms. The failure to review audit trails suggests inadequate validation.
Excerpt: You maintain manufacturing IPC test instrumentation. computerized systems that includes a (b) (4) Integrity Tester, and with each instrument having an audit trail.
View Details
Appropriate controls are not exercised over computers or related systems
Zydus Lifesciences Limited		 23 Apr 2024 Normal Justification: The validation process ensures that computer systems operate correctly and produce accurate, reliable output. This observation points to deficiencies in the system’s validation regarding data integrity and operational reliability.
Excerpt: The software is not configured with an autosave function, allowing analysts to make changes to entry before manually saving without committing the changes to the audit trail.
View Details
Computer systems are not maintained within an appropriate state.
Amphastar Pharmaceuticals, Inc.		 01 Mar 2024 Normal Justification: The failure to validate spreadsheets directly impacts the reliability and accuracy of test results and product quality.
Excerpt: Excel spreadsheets used to perform assay and impurity calculations were not validated to ensure accuracy of the test results obtained.
View Details

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Go back

Computer System Validation

Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

Written By
Vivek Gera
Reading Time
8
Minutes
Share

Computer System Validation

Overview

17
Form 483s Issued
2
483s converted to WL
17
Total Observation
Form 483s Issued
+74 from last period

FDA Trends

Form 483 Conversion Rate by Year
Form 483s Issued (Yearly)

Recent Form 483s & Warning Letters

Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
06 Jan 2025
Suzhou Suncadia Biopharmaceuticals Co. Ltd.
Drugs
View Form 483
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
View Form 483
07 Jun 2024
Frederick Manufacturing Center
Drugs
View Form 483
23 Apr 2024
Zydus Lifesciences Limited
Drugs
View Form 483
View Warning Letter
01 Mar 2024
Amphastar Pharmaceuticals, Inc.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Arsen Karapetyan
3
0
Camerson E Moore
2
0
Yasamin Ameri
2
0
Andrew 'Drew' Haack, PhD
1
0
Brian Janelsins, PhD
1
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Automatic or electronic equipment, including computers or related systems, are not routinely calibrated, inspected, or checked according to written programs
Suzhou Suncadia Biopharmaceuticals Co. Ltd.		 06 Jan 2025 Normal Justification: Computer System Validation is implicated as documentation and maintenance of SCADA software validation were inadequate.
Excerpt: SCADA software validation requirements are not documented, maintained, and updated.
View Details
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Exela Pharma Sciences LLC		 15 Nov 2024 Normal Justification: The use of non-validated Excel workbooks for stability sample inventory and defect data management presents significant risks to data integrity, violating regulatory expectations.
Excerpt: Your firm uses a non-validated system (Excel workbooks) to manage the stability samples inventory.
View Details
Analytical instruments in support of manufacture are not adequately controlled in assurance of data integrity
Frederick Manufacturing Center		 07 Jun 2024 Normal Justification: Computer system validation ensures that computerized systems function as intended, including audit trail mechanisms. The failure to review audit trails suggests inadequate validation.
Excerpt: You maintain manufacturing IPC test instrumentation. computerized systems that includes a (b) (4) Integrity Tester, and with each instrument having an audit trail.
View Details
Appropriate controls are not exercised over computers or related systems
Zydus Lifesciences Limited		 23 Apr 2024 Normal Justification: The validation process ensures that computer systems operate correctly and produce accurate, reliable output. This observation points to deficiencies in the system’s validation regarding data integrity and operational reliability.
Excerpt: The software is not configured with an autosave function, allowing analysts to make changes to entry before manually saving without committing the changes to the audit trail.
View Details
Computer systems are not maintained within an appropriate state.
Amphastar Pharmaceuticals, Inc.		 01 Mar 2024 Normal Justification: The failure to validate spreadsheets directly impacts the reliability and accuracy of test results and product quality.
Excerpt: Excel spreadsheets used to perform assay and impurity calculations were not validated to ensure accuracy of the test results obtained.
View Details

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