Pharma & biotech software & systems2020-08-12T09:57:31+00:00

Software & systems in the Pharma & biotech field

Unlike in the past, most infrastructure, manufacturing and packaging systems, Track & Trace systems, testing equipment and laboratory equipment used in pharma and biotech, are connected/managed / controlled/controlled / operated using the software.
Besides, central and local control and monitoring systems used in factories, production departments and laboratories, based on software or at least contain software components. Many pharmaceutical manufacturing establishments in the world have even undergone complete computerization/digitization of production processes and therefore, the domain of integrity and reliability of the data obtained from the software used, both at the pharmaceutical product level and as part of the support processes, despite the huge contribution to progress, also carries many risks And for critical process parameters, there is an impact on product quality and safety and, as a result, on the health of the consumer/patient.

In the pharma and biotech industries, computerized systems and electronic records must be used, which we trust and assure that the data obtained through them will be accurate, reliable, controlled, complete so that the source data is fully matched over time.
Incorrect/inaccurate data or a bug in the computerized system may cause an improper/invalid /dangerous product to reach the markets and endanger human life. Characterization of the software used, understanding the regulatory requirements of each target market, performing risk analysis, protection and medical information confidentiality, Data Integrity and Validation will be required as part of conducting regulatory reviews of the various health ministries and will also be required to integrate the product registration with the World Health Authorities.

What customers think of us

Software & systems consulting services in the pharma & biotech field

  • Verification & Validation for software and control systems

  • CSV and 21CFR part 11 employee trainings

  • HIPAA and GDPR risk assessments

  • ISO 27001 and ISO 27799 certification

  • ISO 14001 certification

  • Track & Trace projects

  • ERP system purchasing and validation

  • Preparation towards external regulatory audits

  • Quality management and GMP systems establishment

  • Master documents, policies and procedures writing

  • Back up, restore and disaster recovery procedures

  • Compliance with 21CFR part 11 requirements

  • Compliance with Annex 11 requirements
  • Compliance with GDPR, PHI, HIPAA, SOC2 requirements

  • Data Integrity and ALCOA

  • Digital Health

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