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Compliance and work efficiency improvements through implementation of a UNIFI Network

Marco Michi

EBF Waters Workshop 15 November 2016

aptuit.com aptuit.com

Outline

Aptuit Overview

Regulated Bioanalysis

Architecture and Software Requirements

UNIFI key features for Regulated Bioanalysis

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3

2005

Oxford, UK

Verona, Italy Now part of the Aptuit group

2007 2010 2016


Our drug discovery & development solutions

Our extensive experience, considerable capabilities and industry insight mean we are in a position to help meet your drug discovery and development challenges. Wherever you are. Whatever your ambitions.

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Drug Design and Discovery

Integrated Chemistry, Manufacture and Controls

IND Enabling Programs

INDiGO®


Regulated Bioanalysis


Key aspects for regulated Bioanalysis Over the GLP and GCP requirements and scientific quality the following aspects are very important for the Bioanalysis lab in a CRO:

Analytical throughput without compromising scientific quality

Robust quality control check

Resource optimization

Fast reporting

Raw data handling (electronic for FDA)

Access management

Software Validation

Disaster Recovery

DATA INTEGRITY, Audit trail and full compliance!!! 6


Main Agencies and Regulatory Guidelines

FDA BMV Guidance, 2001 EMA BMV Guideline, 2012 FDA GLP: 21 cfr 58 OECD GLP ICH M3 (R2) EMA Reflection paper for laboratories that perform the analysis or evaluation of clinical

trial samples (2012) EMA Guideline on the investigation of bioequivalence (2010) FDA CFR 21Part 11 GAMP 5 General Principles of Software Validation; Final Guidance for Industry and FDA Staff Data Integrity and Compliance With CGMP Guidance for Industry (FDA draft) OECD Number 17 (more recent one) Green guidelines are specific for clinical trial support Red guidelines are specific for data integrity and software validation

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General considerations Our Bioanalytical lab produce:

More than 50K results per year

About 500 reports/contributions

9 LC-MS/MS working also overnight

More than 90 methods developed and qualified or validated per year

24 total headcounts 18 active analysts 2 sample managers

Key aspects to define:

PROCESSES

INSTRUMENTS and SOFTWARE

IFRASTRCUTURE

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Main Bioanalytical Access Requirements

Raw data can’t be deleted or modified in any process phase

Modifications should be easily identifiable by reviewers and auditors

Audit should be performed on original raw and processed data (electronic)

Archived data can be accessible only to the Archivist

All these requirements are not easily implemented by means of a desktop installation

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Software and Architecture


Infrastructure selection Local installation is the simpler, each system is a stand alone system

Manual data transfer or network acquisition

Instruments should be manually synchronized with the last method version

Several files are usually moved/handled manually using windows explorer

Risk for data deletion or corruption

Metadata search is not possible

An higher rating in the Risk assessment profile requires more validation effort

Network installation All LC/MS systems are controlled by a single central software

access management, permissions and method parameters are centralized

Possibility to monitor all instruments from a single user interface

No manual raw data transfer

Data segregation more easy to be implemented

Single central software ensure all the systems behave the same

Metadata search is possible

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Software and instrument selection

Historically the choice was mainly driven by the instrument selection based

on mass spec performance

Today, software are becoming more and more important and for some

applications are more important than some mass spec specifications

For regulated Bioanalysis it is crucial to select a software that

ensure DATA INTEGRITY

minimize

Use the current method version

Avoid accidental deletion of the data.

UNFI network solution was selected to accomplish all these points

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Installed Network System Diagram DL380 3.5GHz x 8 cores, 32GB RAM 1 unit 600GB RAID 1 for OS, DB (Oracle 12) and application 1 unit 3.2 TB RAID 5 for Oracle data 1 unit 3.7 TB RAID 5 for Fast Recovery Area (FRA)

\\itnt06\UNIFI

Win7 64bit, 4GB RAM

i7 Win7 64bit, 8GB RAM, 500GB HDD

Instrument 1

Client PC 1 ( physical / virtual )

LND 1

Client PC 4 ( physical / virtual )

Instrument 2

LND 2 UNIFI Server

File Share

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Disaster Recovery Configuration Strategy:

5 + 1 spare disks are configured for each RAID 5

Operative System and DB application on RAID 1 array

Daily backup on FRA RAID 5 and on external data center

Virtual installation of the system on Cloud Service

Restoring Process:

Data Base (including study data) can be restore from FRA and External Data Center back-ups

Operative system and DB configuration can be restored from Virtualized Installation

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Bioanalytical Process Related to UNIFI Bioanalytical process with UNIFI

Stud

y Se

t Up

Acqu

isitio

nPr

oces

sing

QC

Revi

ewQ

A Au

dit (

if re

quire

d)Ar

chiv

ing

Biolims

Analyst

Print Worklist Sequence

Biolims

AnalystCreate Worklist and

Export in shared area

Worklist Sequence.XLS

UNIFI

Analyst

Import Worklist Sequence

UNIFI

Analyst

Start Acquisition

UNIFI

Analyst

Chromatograms integration

UNIFI

AnalystOpen the Approved report and export

results to s.a.Biolims

Analyst

Import Excel fileResults by 15'

Biolims

Analyst

Apply results code and accept Worklist

Worklist Sequence

ChromatrogramsInfo FileAudit Trail



UNIFI

Analyst(if Required) Export UNIFI Report in pdf

in s.a.

Have you processed all

Runs?

UNIFI

ReviewerReview

Chromatograms and sign report

Reviewer

Check Study File integrity and send to QA (when required)

UNIFI

AnalystProduce Analysis

Report using approved template

Biolims

ReviewerReview Results and apply QC checked

statusAny issue?

UNIFI

QA

Review electronic data

Any issue?

END

START

Biolims

AnalystCreate the Assay

accordingly to the UNIFI Analysis Meth

UNIFI

Analyst

Create the Analysis Method

UNIFI

Analyst

Create the Project Folder

Reviewer• Review Analytical Data,

BioLims Result code

• Verify the data of the last Signed Report report version in UNIFI are imported in BioLims

• Sign PCS_213

Any issue?

Analyst

Perform the required Corrective

Action

YesYes

Biolims

ReviewerCheck data and mark Study as

Completed

Yes

UNIFI

Analyst

Sign electronically the report

Yes

UNIFI

AnalystChange folder

project status to Off-line

Analyst

Final Review to ensure data

integrity

Analyst

Send paper to ACR and PDF to

electronic device

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UNIFI key features for Regulated Bioanalysis when RAW data are defined as electronic RAW data


Analysis Method

All method parameters, sample list properties, processing settings, reporting template and historical versions are grouped in a single item called (Analysis Method)

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Analysis Method Comparison

Analysis method are versioned and only the differences between two versions can be displayed and highlighted

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Analysis: review process can be customized with multiple panes and views

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Reporting: highly customizable report template

all analysis data in a single item convertible to .pdf format for long term archiving purpose

Reported data are automatically kept synchronized

No risk to report superseded data

Many report items can be used

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Central Library: Custom or Master libraries

All information including mass spec optimized parameters are available in a central repository

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Central System Monitor

All Mass Spec are under control and estimated time to finish the analysis is reported

All Mass Spec can be remotely controlled and policies for e-mail alerts can be customized

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Central Administrator

Admin features are active based on user profile.

Custom field are highly customizable

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Other useful features Audit trail reasons for change are “intelligent”

Reasons are customizable and many predefined are available

Assay functionalities, system behavior and available features change

depending on the selected type of assay (e.g.: quantify small molecule,

peptide, matrix effect, Tof, metabolite id, MSe etc.)

Possibility to import all .pdf and Office files into the system

LND PC take care of your analysis ensuring access protection

Personal home page to control draft/on-going analysis and report pending

electronic signature is available with alerts when due date is close to expire

Possibility to electronically archive data with one click

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Conclusions Network UNIFI Installation demonstrated to:

Improve compliance and data integrity compared to typical desktop installation

Make the electronic data archiving easier

Make review faster following predefined workflows

Make the data migration to .pdf file for long term archiving purpose faster

Ensure work flexibility

Make software validation simpler

Reduced likelihood of human error

non-compliant actions are limited or inhibited and worming messages are prompted

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