Inquietudes relacionadas con la Integridad de Datos:

Uso de Excel en un laboratorio regulado

Webinar
28 de Agosto de 2019

©2019 Waters Corporation COMPANY CONFIDENTIAL 1

 Webcast Notes

▪ Please use the Q&A feature to submit questions during the webinar.
We will get to as many questions as time allows at the conclusion of the event

▪ Upon conclusion, follow up information will be sent via email. This includes:

▪ PDF copy of today’s slides

▪ Any questions we were not able to get to during the event

©2019 Waters Corporation COMPANY CONFIDENTIAL 2

 Today’s Presenters

Conferencista: Moderadora:
Carlos Melendez Adriana Tirado
Sr. Informatics Support Specialist Especialista de Desarrollo de Mercado
Waters Corporation Waters Corporation

Q&A Panel: Q&A Panel:

Jason Loftus Shirley Wong
Informatics Business Development Informatics Field Marketing
Waters Corporation Waters Corporation

©2019 Waters Corporation COMPANY CONFIDENTIAL 3

 Agenda
Data Integrity Concerns and Excel
Spreadsheets

NuGenesis Overview

Demonstration: NuGenesis Preconfigured

Solutions for Excel Remediation

Summary

©2019 Waters Corporation COMPANY CONFIDENTIAL 4

 Agenda
Data Integrity Concerns and Excel
Spreadsheets

NuGenesis Overview

Demonstration: NuGenesis Preconfigured

Solutions for Excel Remediation

Summary

©2019 Waters Corporation COMPANY CONFIDENTIAL 5

 Data Integrity Guidances

Medicines & Healthcare Products

Website Q and A 2015, Regulatory Agency (UK)
For GLP, April 2016
Updated Guidance December 2018 ‘GXP’ Data Integrity, March 2018

ISO/IEC:
Q and A: August 2016 EPA QA/G-8,
Released June 2016, 17025:2017
November 2002
as WHO_TRS_996 Annex 5 December 2017

Pharmaceutical Inspection
Co-Operation Scheme Points to Consider Series:
PI-041-1 (DRAFT 3), Conduct: March 2016 GAMP: RDI Guide Guidance
Fundamentals: Sept 2016 Document
30 November 2018 Published
Data Integrity: In Progress
April 4th 2017 October 2016
©2019 Waters Corporation COMPANY CONFIDENTIAL 6
 ALCOA+
Key Factor in Data Integrity
Attributable Who acquired the data or performed an action?
A
Legible Can you read and understand the data entries?
L
Contemporaneous Were records documented at the time of the activity?
C
Original Is it the first recorded observation (or a verified, true copy)?
O
Accurate Is the result scientifically valid and error free?
A
Complete All data including any repeat or reanalysis performed
Consistent All elements of the analysis are date/time stamped in the expected sequence
Enduring Recorded in a permanent, maintainable form throughout its lifecycle
+
Available For review, audit, or inspection over the lifetime of the record

©2019 Waters Corporation COMPANY CONFIDENTIAL Stan W. Woollen, Sr. Compliance Advisor 7
 Recent 483 Observations

 March 2018 Observation 61; Laboratory records do not include complete data derived from all tests…
Electronic records are used, but they do not meet requirements to ensure that they are trustworthy,
reliable and generally equivalent to paper records.
– Specifically, your firm failed to assure the accuracy and reliability for data recorded which are derived or
entered using non-validated and unprotected excel spreadsheets that are not managed
and controlled to ensure unauthorized changes do not occur per your firm’s written procedures.

 Nov 2017 Multiple observations2; Input to and output from the computer, related systems of formulas
and records or data are not checked for accuracy
– The use of uncontrolled spreadsheets is used during the electronic review of final release specifications for
potency by your firm's chemical analytical laboratory. Your analyst demonstrated the final
release potency limits on this spreadsheet are unprotected and can be altered.
– Electronic logs of Quality System reports or files are maintained on uncontrolled spreadsheets. These uses of
these spreadsheets are not referenced in any written procedure and do not have an audit trail
function to track manipulations. 1:www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
CDERFOIAElectronicReadingRoom/UCM604327.pdf
2:https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm592780.pdf
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm592776.pdf

©2019 Waters Corporation COMPANY CONFIDENTIAL 8

 July 2013

 Failure to implement access controls and audit trails for laboratory computer
systems.
– Additionally, at the … facility, the investigator noticed that the use of the Excel
spreadsheets in analytical calculations are neither controlled nor protected
from modifications or deletion. The investigator noticed that the calculation for
residual solvent for (b)(4) uses an Excel spreadsheet that has not been qualified.

– “We are concerned about the data generated by your QC laboratory from non-
qualified and uncontrolled Excel spreadsheets. ”

©2019 Waters Corporation COMPANY CONFIDENTIAL https://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm369409.htm 9

 October 2015

 Your firm failed to prepare batch production and control records for each batch of
drug product that include documentation of the accomplishment of each
significant step in the manufacture, processing, packing, or holding of the batch
(21 CFR 211.188(b)).

– Two uncontrolled Excel spreadsheets were used to record discrepancies and

certain in-process drug quality data. This data was initially missing in the batch
manufacturing record. Your firm later entered this data into batch records and backdated
them.

©2019 Waters Corporation COMPANY CONFIDENTIAL https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm474013.htm 10

 Excel Spreadsheets

 Do you use Excel spreadsheets?

Yes? No?
 Do you validate and protect your Excel spreadsheets?
Yes? No?
 How easy is it to crack that Excel protection?

©2019 Waters Corporation COMPANY CONFIDENTIAL 11

 Crack Excel Protection

©2019 Waters Corporation COMPANY CONFIDENTIAL 12

 Compliance - The missing MS Excel Tab

©2019 Waters Corporation COMPANY CONFIDENTIAL 13

 Microsoft Excel
(For Example)

 Issues in a compliant laboratory

– No login
o How do you know who did a calculation?
– No audit trails
o How do you know what was done, why it was done, or whether it was tried multiple times
to get the ‘right’ answer?
– Manual data transfer
o How do you know the values were entered correctly?
– Manually manage versions
o How do you ensure people use the correct version of a spreadsheet?

©2019 Waters Corporation COMPANY CONFIDENTIAL 14

 Agenda
Data Integrity Concerns and Excel
Spreadsheets

NuGenesis Overview

Demonstration: NuGenesis Preconfigured

Solutions for Excel Remediation

Summary

©2019 Waters Corporation COMPANY CONFIDENTIAL 15

 Generalized Scientific Workflow
Generation, Recording,
and Processing
Data Generation/Recording (Sample Preparation) (Chromatographic Analysis)
Test Select Test Calculate
Sampling Request SOP Preparation Test Results

Retention/
Reporting and Checking (Decision)
Retrieval

Data Certificate Review Data Report Review

Archived of Analysis Data Compiled Results Data

©2019 Waters Corporation COMPANY CONFIDENTIAL 16

 Generalized Scientific Workflow
Generation, Recording,
and Processing
Data Generation/Recording (Sample Preparation) (Chromatographic Analysis)
Test Select Test Calculate
Sampling Request SOP Preparation Test Results

Retention/
Reporting and Checking (Decision)
Retrieval

Office Workflow
Data Certificate Review Data Report Review
Archived of Analysis Data Compiled Results Data

©2019 Waters Corporation COMPANY CONFIDENTIAL 17

 NuGenesis LMS

 Single Platform for….

©2019 Waters Corporation COMPANY CONFIDENTIAL 18

 Capturing Scientific Data of any Analytical System

Sampling Analytical Data Data Processing File Data Report

Acquisition

Including

Data Printed Long Term Archive

Archive Results Data Retention
and Legal Hold

©2019 Waters Corporation COMPANY CONFIDENTIAL 19

 Data Management for Your Whole Lab in One Place

Lab Data

...since you use more than Empower

©2019 Waters Corporation COMPANY CONFIDENTIAL 20

 NuGenesis:
Preconfigured Solution for Excel Remediation

Benefits
Drag… ▪ Drag...Drop...Lock spreadsheets
Drop…
Lock… ▪ Immediate use of already existing
Excel spreadsheets

▪ Authorized access control to Excel

spreadsheets and automated version
control

▪ Full Audit trail, cell level auditing and

e-signature control
A centralized storage of Excel spreadsheets for use in a
regulated environment

©2019 Waters Corporation COMPANY CONFIDENTIAL 21

 Agenda
Data Integrity Concerns and Excel
Spreadsheets

NuGenesis Overview

Demonstration: NuGenesis Preconfigured

Solutions for Excel Remediation

Summary

©2019 Waters Corporation COMPANY CONFIDENTIAL 22

 NuGenesis LMS:
Preconfigured Solution for Excel Remediation

©2019 Waters Corporation COMPANY CONFIDENTIAL 23

 Agenda
Data Integrity Concerns and Excel
Spreadsheets

NuGenesis Overview

Demonstration: NuGenesis Preconfigured

Solutions for Excel Remediation

Summary

©2019 Waters Corporation COMPANY CONFIDENTIAL 24

 NuGenesis:
Preconfigured Solution for Excel Remediation

 Your secure and centralized repository for all your laboratory spreadsheets

 Provides full audit trail for traceability and data confidence

 User access control and version control to Excel spreadsheets

 Reduction of errors due to inadvertent changes being made and saved over the
same filename.

©2019 Waters Corporation COMPANY CONFIDENTIAL 25

 Q&A

©2019 Waters Corporation COMPANY CONFIDENTIAL 26