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Sub System /
Software Lifecycle Management
Software Lifecycle Management
View Detailed Analysis

Analytics Overview

11
Form 483s Issued
1
483s converted to WL
11
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 Nov 2024
ARUP Laboratories, Inc.
Drugs
25 Nov 2023
ABC Pharmaceuticals Inc.
Drugs
15 Oct 2023
ABC Pharmaceuticals
Drugs
01 Oct 2023
ABC Pharmaceuticals Inc.
Drugs
01 Oct 2023
ACME Pharmaceuticals Inc.
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Jane Smith
6
0
John Doe
6
0
John Smith
2
0
Jane Doe
2
0
Alice Brown
1
0
TITLE/ COMPANY Issue Date Status Details
(b) (4) are not checked for accuracy.
ARUP Laboratories, Inc.
06 Nov 2024 Normal Justification: Issues arose from poor lifecycle management practices, failing to incorporate adequate testing and validation phases.
Excerpt: Your firm failed to adequately test the (b) (4) of your new (b) (4) related to your (b) (4).
View Details
Failure to validate software used as part of production, quality system, and service as required by 21 CFR 820.70(i)
ABC Pharmaceuticals Inc.
25 Nov 2023 Normal Justification: The observation specifically mentions the failure to validate software, directly implicating software lifecycle management processes.
Excerpt: Specifically, the software used for production scheduling and inventory management (version 3.2) has not been validated.
View Details
Your firm failed to adequately validate software used as part of production or the quality system
ABC Pharmaceuticals
15 Oct 2023 Normal Justification: Software Lifecycle Management is directly affected as the observation relates to validation protocols, a critical component of managing software throughout its lifecycle.
Excerpt: Your firm failed to adequately validate software...for its intended use according to an established protocol.
View Details
Your firm failed to adequately validate the design and release of changes to software used as part of production and the quality system.
ABC Pharmaceuticals Inc.
01 Oct 2023 Normal Justification: Software Lifecycle Management requires that all software updates are validated to verify they meet user needs and intended use.
Excerpt: update to version 2.3 on 01/15/2023 without performing a design validation to ensure ...
View Details
Failure to establish and maintain procedures for changes to a specification
ACME Pharmaceuticals Inc.
01 Oct 2023 Normal Justification: Software lifecycle management is impacted as the failure pertains to software changes without procedural integration.
Excerpt: No documented procedures for implementing changes to the software of the automated production line.
View Details

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Software Lifecycle Management

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

Software Lifecycle Management

Overview

11
Form 483s Issued
1
483s converted to WL
11
Total Observation
Form 483s Issued
+74 from last period

Recent Form 483s & Warning Letters

Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
06 Nov 2024
ARUP Laboratories, Inc.
Drugs
25 Nov 2023
ABC Pharmaceuticals Inc.
Drugs
15 Oct 2023
ABC Pharmaceuticals
Drugs
01 Oct 2023
ABC Pharmaceuticals Inc.
Drugs
01 Oct 2023
ACME Pharmaceuticals Inc.
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Jane Smith
6
0
John Doe
6
0
John Smith
2
0
Jane Doe
2
0
Alice Brown
1
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
(b) (4) are not checked for accuracy.
ARUP Laboratories, Inc.
06 Nov 2024 Normal Justification: Issues arose from poor lifecycle management practices, failing to incorporate adequate testing and validation phases.
Excerpt: Your firm failed to adequately test the (b) (4) of your new (b) (4) related to your (b) (4).
View Details
Failure to validate software used as part of production, quality system, and service as required by 21 CFR 820.70(i)
ABC Pharmaceuticals Inc.
25 Nov 2023 Normal Justification: The observation specifically mentions the failure to validate software, directly implicating software lifecycle management processes.
Excerpt: Specifically, the software used for production scheduling and inventory management (version 3.2) has not been validated.
View Details
Your firm failed to adequately validate software used as part of production or the quality system
ABC Pharmaceuticals
15 Oct 2023 Normal Justification: Software Lifecycle Management is directly affected as the observation relates to validation protocols, a critical component of managing software throughout its lifecycle.
Excerpt: Your firm failed to adequately validate software...for its intended use according to an established protocol.
View Details
Your firm failed to adequately validate the design and release of changes to software used as part of production and the quality system.
ABC Pharmaceuticals Inc.
01 Oct 2023 Normal Justification: Software Lifecycle Management requires that all software updates are validated to verify they meet user needs and intended use.
Excerpt: update to version 2.3 on 01/15/2023 without performing a design validation to ensure ...
View Details
Failure to establish and maintain procedures for changes to a specification
ACME Pharmaceuticals Inc.
01 Oct 2023 Normal Justification: Software lifecycle management is impacted as the failure pertains to software changes without procedural integration.
Excerpt: No documented procedures for implementing changes to the software of the automated production line.
View Details

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