How to solve legacy instruments Data Integrity gaps

inpharmatic data integrity gaps

Some instruments in the labs are not compliant to Data Integrity requirements

At present, in the labs, there are still “legacy” measuring instruments, i.e. instruments that are there since ever and very often they’re not fully compliant to Data Integrity requirements. Usually, the remediation of their Data Integrity gaps is an issue, because a compliant new instrument is either not available or, for any reason, the instrument cannot be substituted, or it is not worth a substitution.

In other cases, as a remediation activity, it is foreseen the installation of the vendor proprietary software that puts the instruments in compliance, but in this way several new software will be introduced in the lab. These ones require a specific validation exercise and the following administration activities, different passwords to remember for the analysts, etc.

Many alternatives try to solve the Data Integrity Gaps

Several powerful applications promise the benefits of instruments integration (LIMS, ELN…) and this seems to be for sure the best solution. But these applications require up-to-date instruments and complex projects to be implemented, in the meanwhile, DI gaps remain for months or even years.

As an alternative, the implementation of an integration platform, a middleware, can put the legacy instruments into compliance and can be the first step towards a full lab digitalization. Its quick installation and simple management make it the ideal starting point to achieve concrete DI-compliant results without the complexity of projects such as ERP, LIMS or ELN.

At the same time, this middleware does not replace these systems, but rather it gives its best when it is placed between laboratory instruments and a LIMS (Laboratory Information Management System).

Using this middleware integration platform, users have the opportunity to:

  • Save time, digitalizing the entire process of measures acquisition;
  • Review the measures;
  • Become familiar with IT systems and better understand the potential and the critical issues of these
    ones, preparing themselves for more challenging projects and for the eventual achievement of a
    completely digitalized scenario.

Why Ioi, Integration of Instruments 

Ioi is a middleware platform that captures laboratory instrument measurements, overcoming the Data Integrity gaps of legacy (but also new) instruments by collecting all the necessary metadata: who did the measure, the date/time of the measure, the instrument ID, the sample ID, the measure engineering unit, etc.

In other words, Ioi digitalize the tickets, because it stores the measures and the related metadata in a secure database (SQL) in full compliance with Data Integrity and without any paperwork.

Preserve your investments by interfacing Ioi

From a practical viewpoint the operator, by the use of a tablet, can:

  • Log into the system (also using the credentials of the company network);
  • Identify the sample reading the sample ID;
  • Identify the instrument automatically or reading the ID;
  • Read automatically the measurement of the instrument;
  • Sign electronically the measurement (where applicable);
  • Time stamp the measure with date and time taken from the network.

Further, Ioi preserves your investments: since when you implement other systems, like LIMS or ELN, you integrate all instruments by interfacing Ioi (one single interface) instead of interfacing every single
instrument (several interfaces).

The platform is scalable, so it’s possible to add new instruments at any moment with a simple
configuration and validation (GAMP sw category 4 instead of scripts belonging to category 5).

Some additional advantages are:

  • Centralized access management (the same access credentials applied to several instruments) with benefits for:
    Users: only one password to remember and to change in case of expiry;
    Administrator: only one account to setup for each user (also by network domain).
  • Automatic time synchronization from the network;
  • Automatic recording of the Sample/Batch ID;
  • Automatic instrument logbook.

 

inpharmatic paperless lab academy

Gold sponsor at #PLA2020 , exhibiting and  Presenting a workshop ” Learn how to solve legacy instruments DI gaps with an instrument integration platform” at #PLA2020


emmanuele inpharmatic PLA2020Emmanuele Dicerto, Chief Technology Officer at Inpharmatic