customer-system-validationComputer System Validation (CSV) or re-validation is required by companies operating in the life sciences industry either when implementing a new software system or modifying a validated one. Properly performing a CSV requires time and effort but prevents the possible damaging impact of failing to implement successful compliance, including costly implementation delays, rework, team integration issues, post-deployment defects, and data integrity questions.

Life sciences companies, including pharmaceuticals, biotechnology, medical devices, food processing, and others, typically operate within the context of GxP (good practice) quality guidelines and regulations. GxP guidelines are established by the U.S. Food and Drug Administration (FDA) and are referenced and applied worldwide.

New eMaint computerized maintenance management system (CMMS) software customers in this sector will need to validate their system software. Existing customers who make changes to the software will need to re-validate the system once the changes are completed.

About the eMaint CSV service

The eMaint CSV and re-validation service offered by Fluke Reliability helps customers simplify, streamline, and accelerate eMaint CMMS computer system validation and re-validation.

Our experts will help you approach the general validation principles of the process confidently. Once executed, you can feel assured of regulatory compliance when facing an inspection or audit.

Benefits of computer system validation and re-validation

  • Helps achieve and sustain continuous readiness for regulatory inspections
  • Eliminates obstacles by using CSV best practices, including GAMP 5 (a technical document that provides guidance to achieving compliant GxP regulated computerized systems)
  • Aligns the CSV initiative with stakeholders — for example, quality, governance, information security, and risk management teams
  • Demonstrates to an organization’s customers and auditors a clear commitment to product safety, and to data quality and integrity
  • Enables improvements in compliance performance, reducing costs
  • Provides easy access to real-time, accurate compliance data

customer system validation

Why perform computer system validation?

A CSV assures regulators and auditors that the production and quality of your eMaint CMMS software are validated according to a written procedure for the particular intended use and will perform as intended in the chosen application in a consistent and reproducible manner.

The scalable Fluke Reliability CSV service helps eMaint CMMS global customers achieve and sustain life sciences industry compliance under the GxP quality guidelines and regulations.

What’s included in the eMaint CSV service?

Our eMaint technical experts will work with your project team during the computer system validation service to confirm that your organization has the foundation and support needed to meet the requirements for preparation and execution.

Computer System Validation services activities include:

  • Functional requirements specification
  • Electronic records
  • Electronic signature
  • Validation environment
  • Operational qualification
  • Trace matrix
  • Computer System Validation execution
  • Artifacts

Why do I need to re-validate my software system?

If computer system software is upgraded or active portions are modified, users must consider the impact on the existing CSV and reconfirm software validation where needed. The eMaint CMMS functionality simplifies this required re-validation process.

The eMaint software is set up to archive and enable quick access to your CSV data, documents, release validation reports, and expedite re-validation.

The eMaint CSV re-validation service provides:

  • Automated operational qualification test scripts
  • Quarterly release cycle (March, June, September, and December)
  • A digital report of the release validation tests, including screenshots

Why are GxP, electronic records, and signatures important to CSV?

Any computerized system under GxP guidelines should be assessed for electronic records and electronic signatures (ERES). eMaint CMMS software has the operational requirements and Fluke Reliability has the administrative, procedural, and technical controls to facilitate customer achievement of FDA 21 CFR part 11 and its European counterpart, EudraLex – Volume 4, Annex 11 compliance.

Part 11 is a law confirming that an organization adopts sound business practices by defining its electronic records and signatures to be accurate, reliable, confidential, authentic, trustworthy, and equal to paper and handwritten signatures.

Within the European Union, medical device makers are required to validate their software and systems. EudraLex Annex 11 is part of the European GMP guidelines. As with FDA 21 CFR Part 11, EudraLex Annex 11 establishes the conditions for defining electronic records and electronic signatures.

21 CFR Part 11 and EudraLex Annex 11 compliance focus on five critical areas:

  1. Impact of regulations on the client’s computer systems, including Quality Management Systems
  2. Identification of the client’s computer systems and operating environment
  3. Review and consideration of client procedures
  4. Analysis of procedural documentation, validation, and audit data
  5. Regulatory significance of the computer systems

Computer System Validation improves business performance

Organizations that regularly validate new and updated software solutions benefit from faster, more efficient systems, including improved product quality and safety for customers, reduced system errors, and more efficient maintenance, lowering overall costs.

eMaint CSV Service

Essential CSV resources

International Society for Pharmaceutical Engineering (ISPE)

ISPE is a global industry leader in connecting pharmaceutical knowledge to deliver manufacturing and supply chain innovation, operational excellence, and regulatory insights to enhance industry efforts to develop, manufacture and reliably provide quality medicines to patients. It is the world’s largest not-for-profit member association.

https://ispe.org/

ISPE GAMP® 5 Guide

The GAMP (Good Automated Practices Practice) guide is a technical document entitled “A Risk-Based Approach to Compliant GxP Computerized Systems” set by the International Society for Pharmaceutical Engineering (ISPE). It provides practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. It describes a flexible risk-based approach to compliant GxP regulated computerized systems based on scalable specification and verification.

https://ispe.org/publications/guidance-documents/gamp-5

General Principles of Software Validation

This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices.

https://www.fda.gov/media/73141/download

CFR – Code of Federal Regulations Title 21

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm

Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application

https://www.fda.gov/media/75414/download

EudraLex Annex 11 – Volume 4

https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf

The Pharmaceutical Inspection Co-operation Scheme (PIC/S)

A non-binding, informal cooperative arrangement between regulatory authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any authority having a comparable GMP inspection system. PIC/S presently comprises 54 Participating Authorities from all over the world (Europe, Africa, America, Asia, and Australasia).

https://picscheme.org/en/picscheme