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Workshop Session

Do you still print and sign instrument reports? We have an alternative to manage them all digitally

Pierluigi Agazzi, Inpharmatic speaker workshop @PLA2021 Europe

Presenter: Pier Luigi Agazzi, Partner and Computer Validation Consultant at Adeodata

Graduated in Electronic Engineer (Master) in 1985, he attended some courses about AI at MIT in Boston and also a Master in Business Administration (MBA) at Politecnico di Milano.
From 1985 to 2000, he worked as an automation and process instrumentation engineer for chemical and pharmaceutical plants in international environments.
Since 2000, he is a Computerized System Validation Engineer and partner of Adeodata.
He took part in several 21 CFR Part 11 compliance assessment and gaps remediation plans for production and QC departments, working with ERP (SAP) and Electronic Batch Record Systems. He is also involved in several Data Integrity assessments.
He is an expert trainer and auditor specialized in computerized systems validation and Data Integrity compliance.
Since 1992, he’s an active member of GAMP Italia group and ISPE.

Overview 

Paper records are still in use in labs. This because of stand-alone systems that are not fully compliant with data integrity requirements, so it is necessary to print a report and note the missing metadata - such as who did what and when - , especially review and approval signatures. This is the case with hybrid systems that require specific and additional controls (PIC/S 041Y1 §9.10).

A possible solution could be to upgrade the system to a new compliant version and/or import the reports into the ELN or LIMS system, usually as PDF attachments. The results would still have to be manually transcribed into the ELN or LIMS system, with a double check to be recorded, because implementing an automatic interface with each instrument is expensive and time-consuming.

Also, this could be complicated with systems that cannot be connected to the network (e. g. instruments that only save reports to a USB stick) or that cannot be updated. Ioi can help in these cases!

Any type of report can be captured by Ioi, even simulating a USB stick, and can be stored in a secure DB for review and approval, or can be uploaded to an ELN or LIMS. In this case, advanced parsing capabilities are also available that could avoid manual transcription of results.

Why should you attend

    • Collect your bench and stand-alone
    • equipment in a unique platform
    • Achieve Data Integrity compliance
    • Digitalize your laboratory with our paperless solution
    • Review electronic data and improve laboratory efficiency

Main topics:

    • Data Integrity
    • Simple and complex instruments integration
    • Paperless data management
    • Lab digitalization
    • Quality improvement

Who should benefit

Analyst, Supervisor, Quality Control Manager, Quality Assurance and IT department

Inpharmatic Srl is a company that develops and integrates software solutions mainly for the pharmaceutical market.
It was born from the partnership of two historically consolidated companies in the reference market:

  • Adeodata, with its contribution of knowledge of digitisation processes, compliance requirements and validation activities.
  • Klan.IT, with its experience in software development (with a wide portfolio of products), integration of platforms/solutions, IT architectures and digital technologies.

The aim of this synergy is to offer the pharmaceutical market specialised solutions for the digitalisation of processes, in full compliance with GMP requirements.
Inpharmatic Srl has developed a suite for the integrated management of processes, consisting of:

  • Ioi - Integration of instruments: paperless and centralised management of laboratory and production GxP data, Data Integrity, control and efficiency.
  • DiLab: digital laboratory notebook

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