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Workshop Session


Ioi: a further step. Digitising laboratory workflows with or without integrating instruments

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 

Last year Inpharmatic introduced Ioi as a platform for the Integration of instruments. Ioi is capable of solving Data Integrity issues without substituting actual (simple or legacy) laboratory instruments.

Our platform electronically captures GMP data from isolated instruments and records the measurements in a central repository, including calibrations and daily checks. It also supports the review and the approval of each measure, and all the related instrument information, such as maintenance interventions.

This year we want to push Ioi one step further: supporting the digitalization of Lab workflows with or without the Integration of instruments.

We will show you how Ioi can merge in a single electronic document:

  • the instructions for the operator,
  • the measurements acquired from an instrument
  • the batch information of the components used (sample, standard, solution, …)

We will also show you how to digitalize the forms used for data collection (e.g. of a microbiological sample) in order to enter information in digital fields automatically and thus prevent errors.

 

Session learnings 

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.

Areas covered in this session 

-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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