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Automating Quality Operations: Challenges Faced by the Life Sciences Industry

Automation - 10 July 2012

It is becoming more evident that authorities worldwide will soon demand real-time standardized data specifically related to Quality Operations. The only way to do so is in modernizing IT infrastructures to facilitate data analysis and exchange. Whether it is an extension to an ERP system or a document management system, EQMS software must provide information on quality related activities at any time.

Before standardizing and automating Quality data, the following steps must be taken:

1. Define

Standards must be set by the Industry Authorities:

For instance, the standards for data produced in clinical trials such as CDISC have emerged allowing global adoption of EDC (Electronic Data Capture).

On June 4 2008, the USA Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese pharmaceutical/medical device regulating authority adopted Pharmaceutical Quality System Q10 or ICH Q10, which was proposed by the International Conference on Harmonization.

Other standards emerged on Quality Systems but they are not at a stage where a specific electronic format has been established to produce product-related quality data. Since Quality is connected with many enterprise units, data format and exchange standards will take time to be implemented in practice.

2. Communicate

Indications that authorities are moving in the direction of standardization can be found in:

    • A special FDA report titled Pathway to Global Product Safety and Quality (revised July 7, 2011)- LINK NO LONGER AVAILABLE

    Extract: Over the next decade, FDA will transform itself from a domestic agency operating in a globalized world to a truly global agency fully prepared for a regulatory
    environment in which product safety and quality know no borders.

    India, China and Brazil, are the focus of these new measures, due to their dominant position in the production of active ingredients for the pharmaceutical industry. On demand
    access to the data from EQMS systems in laboratories in these countries, will facilitate timely interventions of the regulating authorities.

3. Implement

Standardization and automation of Quality Systems are irreversible trends.

In our opinion, the common goals of the Quality sector in Life Sciences organizations can be summarized as:

  • Become more precise with the Quality standards and get more involved in metrics that should be readily available. The authorities and the Industry will have to define more clearly what is expected as standard point of verifications in terms of quality-related activities.
  • Quality management system vendors for the Pharmaceutical, Medical Device and Biotech industries must work with industry specialists to establish data standards in order to clearly define expected formats.
  • Interfaces between an EQMS software and other enterprise software systems will be essential as Quality units must be connected with many other business units.