Deleting Electronic Data

Hybrid Systems (Deleting Electronic Data)
In Hybrid systems the computerised system is used to generate a record which is printed and hand signatures applied. The decision for the regulated company is whether the electronic record (or raw data) should be kept or deleted from the system.

In the FDA Guidance “Part 11, Electronic Records; Electronic Signatures — Scope and Application” under

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CSV Periodic Review

Regulatory requirement
Both the FDA and EU GMP’s detail the requirement for demonstrating that a computer system remains in a validated state throughout its operating history.

FDA 21 CFR 211.68(b) States:
“Input to and output from the computer or related system of formulas or other records or data shall be checked for accuracy. The degree and frequency of input/output verification shall be based

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Spreadsheet Validation

Spreadsheets have become commonly used within a wide range of applications within the pharmaceutical and biotechnology industries. These range from the management of documentation lists through to complex algorithms used to support batch release.

This post provides a description of a risk based approach to the validation of spreadsheets. As with all posts comments are welcome.
The approach to

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FDA Announce Part 21 CFR 11 Inspections

Image via WikipediaAs detailed within the post 21 CFR Part 11 Warning Letters the FDA are planning to start conducting part 11 inspections soon.

Published on the FDA website the agency states:

The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003

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Software Validation

The validation of computer software within the Pharmaceutical Industry is providing documented evidence that the software and computer system is fit for its intended purpose.

Quality can not be tested in to the system it must be designed. This is why developing a lifecycle approach to software validation should be taken, to design in quality from concept, through the requirements, design and

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Auditing Software Suppliers (Part 1)

Introduction to Software Supplier AuditsThis blog is the first of a series of planned articles on the process for quality system auditing suppliers of software and computerised systems. This blog concentrates on the GMP and Regulatory requirements for performing supplier audits, future posts are planned for discussing the auditing process.

A supplier quality audit can be a critical phase of any

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CSV FDA Warning Letters : Security / Audit Trail

Date: 12 August 2008
Link: FDA Warning Letter (New Window)

Observation6. Failure to establish appropriate controls over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel as required by 21 CFR 211.68 (b).
For example, the [redacted] data acquisition system for the [redacted] UV/Visible

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