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Computerized System Validation

Computerized System Validation-Treata Padideh Sanat

Computerized system validation provides documented proof that the system (e.g. Hardware, software, peripherals and network) will repeatedly and reliably do what it is designed to do, is “fit-for-purpose”, and complies with the applicable rules and regulations.

Validation of computerized systems according to GxP Guidelines (CSV) has been a basic requirement in the healthcare industry for many years.

Computer system validation is definitely not a “one size fits all” procedure; the approach that an individual company may take to a specific validation depends on the rules, guidance, best practices, and characteristics of the system being validated.

TPS Company offer consultation services to support the implementation of CSV and ERES (CFR Part 11) based on the Guideline on Management of Computerized Systems set forth by the Ministry of Health, Food and Drug Administration, and Good Automated Manufacturing Practice (GAMP), including latest debates and trends.

Our CSV experts help in analysis, design, execute and manage validation requirements as per the FDA, EU and various global compliance requirements.

Software Validation
MS Excel Spreedsheet Validation
Software Validation

Computer software validation must show that the system operates predictably according to its specifications, and that conclusion is supported by formal, documentary evidence because regulators will not take your word for it.

Computer software validation is a sound business practice that supports quality assurance, and promotes responsible and profitable operations. Computer software provides the evidence that a computer system does what it is intended to do according to the system specifications and operating procedures.

TPS company can validate all of your software, databases, spreadsheets, and computer systems, and develop the appropriate documentation for all phases of the software life cycle.

We can provide any level of service required, from executing test scripts generated from your existing specifications to writing the entire validation package.

TPS’s goal in all software validation projects is to improve the quality, value, and compliance of your computer system.

TPS will perform risk assessments to focus the validation effort on the most appropriate sections of your system.

Steps of software validation:

  • User Requirement Specification (URS)
  • Project Plan
  • Functional Specification Document
  • Gap Analysis
  • Installation Protocol
  • Installation Report
  • Testing Protocol
  • Testing Report
  • System Release
  •  Validation Complete

Outputs:

  • Validation Plan (VP)
  • User Requirements Specification (URS)
  • Validation Risk Assessment (VRA)
  • Installation / Qualification / Performance Qualification (CSQ) protocol

 

MS Excel Spreedsheet Validation

Since the spreadsheet is used to support an activity governed by any applicable regulation, typically GMP’s, GLP’s, Medical Devices etc.; it should be validated.

Spreadsheet validation is an often neglected task and one that attracts the attention of all regulators, simply because they are pretty certain that they will find problems in the use, or design, or in the actual spreadsheet validation and or qualification.

TPS company provide presentations on all aspects of spreadsheet validation and MS Excel compliance with 21 CFR 11 and Annex 11. TPS company have the strategies for designing compliant spreadsheets, addressing the compliance risks associated with spreadsheets, and how to protect spreadsheet data throughout the data retention period. Steps of MS Excel Spreadsheets validation:

  • User Requirement Specification
  • Project Plan
  • Functional Specification Document
  • Testing Protocol
  • Testing Report
  • Validation Complete

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