Use of Computerized Systems to Support GxP Quality Processes at Eli Lilly and

Title: Company

GQS-RES-101-4-0058
Document
Number:

Version: Reviewers – Date (YYYY-MM-DD) and Time Approved.

N/A Susan Schebler - 2014-05-12T06:37:46

Status (at print):

Approved

Effective Date: Approvers – Date (YYYY-MM-DD) and Time Approved.

N/A Kira L Ford - 2014-05-12T09:33:58

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CONFIDENTIAL
 Resource RES-101-4
Version number Document Title Associated GQS
1 GQS101
Effective Date Secondary GQS
01-Jan-2015
Use of Computer Systems to Support GMP LQS302
Superseded Documents Quality Processes at Eli Lilly and Company
RES-101-4 ver0 Page 1 of 11

Approval
Approved by (printed name and title):
Kira Ford, Director – Global Quality System – Quality

Purpose
The use of computer systems is integral to GMP operations. Computer systems provide both the
functionality to guide operations and documentation of the execution of these activities.

This document holistically describes how computer systems, and the data contained within them,
support and integrate with Lilly’s Quality Systems. It also contains tables showing which global
computer systems support the key quality processes (e.g., batch release, CAPA).

Scope
This resource focuses on centralized processes, roles and responsibilities to support global or
multi-site (regional) computer systems. These concepts can also be applied to local computer

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systems supporting GMP processes. The attachments list global and multi-site centrally
supported IT applications only.

This resource pertains to the following types of operations:

materials receipt testing storage
production release distribution
packaging and labeling

This resource pertains to the following types of products:

raw materials finished products
intermediates animal health premixes
active pharmaceutical ingredients medical devices
bulk drug products drug/device combination products
drug products

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 Resource RES-101-4
Version number Document Title Associated GQS
1 GQS101
Effective Date Secondary GQS
01-Jan-2015
Use of Computer Systems to Support GMP LQS302
Superseded Documents Quality Processes at Eli Lilly and Company
RES-101-4 ver0 Page 2 of 11

Table of Contents
1.0 Overview ............................................................................................................................. 3
2.0 Integrated Standards............................................................................................................ 3
2.1 Quality in Design ............................................................................................................ 3
2.2 Quality in Execution ....................................................................................................... 4
2.3 Quality in Monitoring ..................................................................................................... 5
3.0 Business Processes .............................................................................................................. 5
3.1 Quality in Design ............................................................................................................ 6
3.2 Quality in Execution ....................................................................................................... 6
3.3 Quality in Monitoring ..................................................................................................... 6
4.0 Organization – Roles and Responsibilities ......................................................................... 7
4.1 Quality in Design ............................................................................................................ 7
4.2 Quality in Execution ....................................................................................................... 8
4.3 Quality in Monitoring ..................................................................................................... 8
5.0 Electronic Data Integrity ..................................................................................................... 9

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5.1 Quality in Design ............................................................................................................ 9
5.2 Quality in Execution ..................................................................................................... 10
5.3 Quality in Monitoring ................................................................................................... 11
6.0 Management of Attachments ............................................................................................ 11
Revision History ........................................................................................................................... 11

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 Resource RES-101-4
Version number Document Title Associated GQS
1 GQS101
Effective Date Secondary GQS
01-Jan-2015
Use of Computer Systems to Support GMP LQS302
Superseded Documents Quality Processes at Eli Lilly and Company
RES-101-4 ver0 Page 3 of 11

1.0 Overview
Computer systems support GMP quality processes. Combined with business processes
and personal behaviors, GMP computer systems are integral to our Quality processes.
This resource uses the Quality Management System model in LQS101 – Quality
Management to describe the design, use, and monitoring of GMP computer systems.
Governance and management controls will be described within the “Quality in
Monitoring” section of the other topics.

2.0 Integrated Standards

Computer Systems are designed, used, and monitored as part of the Quality Management
System. The integrated standards provide the high level requirements.
2.1 Quality in Design
Lilly’s GMP computer systems are designed and validated to support operation in
compliance with the requirements in the applicable Quality Standards and Practices.

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When standards are revised (e.g., to review audit trails per revision to Annex 11) the
applicable computer systems are evaluated to determine if modifications will be
required. The following standards apply to the design and implementation of GMP
computer systems.
a. LQS302 – Computer Systems and Electronic Records; Electronic Signatures and
the associated (LQP) practices define computer validation requirements.
b. GQS105 – Documentation and Data, defines documentation requirements for all
GMP operations. These requirements apply to all forms of documentation,
including electronic systems, electronic media and hard copy.
c. GQS201 – Delivery of Physical Assets, describes requirements for
commissioning and qualifying a GMP asset, including the related process
control and/or monitoring systems.
d. GQS605 – Analytical Equipment, describes the requirements for qualifying
analytical equipment or systems.

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 Resource RES-101-4
Version number Document Title Associated GQS
1 GQS101
Effective Date Secondary GQS
01-Jan-2015
Use of Computer Systems to Support GMP LQS302
Superseded Documents Quality Processes at Eli Lilly and Company
RES-101-4 ver0 Page 4 of 11

2.0 Integrated Standards, continued

2.2 Quality in Execution
GMP computer systems are used and managed in compliance with the requirements in
LQS302 – Computer Systems and Electronic Records; Electronic Signatures and the
applicable Quality Standards and Practices.
The following apply to change and deviation management in GMP computer systems.
a. LQP-302-6 – Change Control, defines the change management requirements for
all computer systems. The IT aspects are managed in the IT change
management tool.
b. LQP-302-7 – Change Control for Platforms, defines the change management
requirements for all IT infrastructure, including hardware and software
platforms. These changes are managed in the IT change management tool.
c. GQS103 – Change Management, defines the change management requirements
for all GMP changes, including those which are caused by or result in changes
to computer systems. These changes, and the associated GMP business impacts

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and implementation steps, are managed in the GMP business change
management system (e.g., TrackWise); with additional IT specific tracking in
the IT change management tool, as required.
d. LQS302 – Computer Systems and Electronic Records; Electronic Signatures,
requires a process for recording and analyzing problems with computer systems.
e. GQS104 – Deviation Management, defines the deviation management
requirements for all deviations which may have GMP impact. Local
investigation into the business aspects of computer system deviations are
managed in the business deviation management system (e.g., TrackWise).

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 Resource RES-101-4
Version number Document Title Associated GQS
1 GQS101
Effective Date Secondary GQS
01-Jan-2015
Use of Computer Systems to Support GMP LQS302
Superseded Documents Quality Processes at Eli Lilly and Company
RES-101-4 ver0 Page 5 of 11

2.0 Integrated Standards, continued

2.3 Quality in Monitoring
Lilly’s GMP computer systems are audited and periodically reviewed for compliance
with LQS302 – Computer Systems and Electronic Records; Electronic Signatures. They
are also audited to determine if the system design and the use of the system remain in
compliance with the applicable Quality Standards and Practices. The following apply to
the audit and review of computer systems:
a. LQS111 – Quality Auditing defines the requirements for self assessments and
internal audits of both the computer system validation and the use by the
business,
b. LQP-302-11 – Infrastructure Area Management Reviews describes the process
for performing area reviews of infrastructure support platform teams,
c. LQP-302-14 – Periodic Review describes the process for performing post-
implementation computer system periodic reviews,
d. LQP-302-21 – Management of Suppliers of Computer Related Products or
Services describes the content of the supplier management plan, if applicable,

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e. GQS200 – Quality Management of Physical Assets, describes the periodic
review requirements for the FUME system, including the associated automation,
and
f. EFS1101 – FUME Periodic Review, describes in detail the approach for FUME
system periodic review, including the associated automation.

3.0 Business Processes

The benefits of GMP computer systems cannot be fully realized unless the proper use of
each system is documented, communicated and consistently followed. Additional
procedural controls have been established to ensure all the requirements of the standards
are met and to facilitate trending and metrics.

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 Resource RES-101-4
Version number Document Title Associated GQS
1 GQS101
Effective Date Secondary GQS
01-Jan-2015
Use of Computer Systems to Support GMP LQS302
Superseded Documents Quality Processes at Eli Lilly and Company
RES-101-4 ver0 Page 6 of 11

3.0 Business Processes, continued

3.1 Quality in Design
Instructions and best practices for consistent use of GMP computer systems are
developed when the systems are being designed. The design requirements (including the
requirements from Quality Standards and Practices) are tested and validated. These
instructions and global best practices are communicated in various ways including:
a. user manuals, field guides, and job aids,
b. global training and templates for local training,
c. global SOPs and example local SOPs, and
d. Quality System documents (e.g., RES-102-2 – Review of Data Changes for
Batch Release Associated Records).
3.2 Quality in Execution
Sites incorporate proper use of the computer systems in their local procedures. Proper
and consistent use enables global trending and metrics and allows the use of automated
interfaces and data extraction tools.

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See section 5.0, Electronic Data Integrity, for additional information on documentation
of business process execution.
3.3 Quality in Monitoring
Management reviews of quality systems, both at the site and the global level, use data
from the applicable computer systems to evaluate the continued suitability, adequacy
and effectiveness of the quality system. These reviews also evaluate how the computer
systems and IT tools are being used to execute that process and if the required business
processes are being followed.

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 Resource RES-101-4
Version number Document Title Associated GQS
1 GQS101
Effective Date Secondary GQS
01-Jan-2015
Use of Computer Systems to Support GMP LQS302
Superseded Documents Quality Processes at Eli Lilly and Company
RES-101-4 ver0 Page 7 of 11

4.0 Organization – Roles and Responsibilities

The Quality oversight requirements are described in LQP-302-1 – Independent Quality
Oversight for Computer Systems and GQS101 – Quality Management. Oversight
includes:
a. monitoring the design, operation, and maintenance of computer systems,
b. ensuring the combination of functionality and business processes meets GMP
requirements, including those in the Quality Standards and Practices, and
c. ensuring the systems are used as designed.
4.1 Quality in Design
Computer system validation resources include qualified computer system technical
resources and business subject matter experts (SMEs). The following quality assurance
roles also participate in the design, validation, and launch of computer systems which
support GMP activities.
a. Computer System Quality Assurance (CSQA) is the quality assurance unit for
Global IT computer systems. They are responsible for compliance with LQS302

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– Computer Systems and Electronic Records; Electronic Signatures. They also
own and maintain the Quality Practices on computer system validation and
provide oversight of testing, validation and technical requirements such as
electronic record and electronic signature (ER/ES) technology and system
security.
b. Business Quality Assurance (BQA) representatives represent the quality and
GMP business requirements for system functionality, records and data. They
interpret the requirements in the Quality Standards and Practices, and they
approve system requirements and change requests (business content/impact on
requirements).
c. Quality Unit Process SMEs represent the QA users of the quality system
processes (e.g., deviation management). They are knowledgeable about
applicable local quality processes and regulatory requirements. They provide
additional expertise to improve system usability. They may also assist with
local implementation by revising procedures, providing training, and doing local
data verifications and local change management.

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 Resource RES-101-4
Version number Document Title Associated GQS
1 GQS101
Effective Date Secondary GQS
01-Jan-2015
Use of Computer Systems to Support GMP LQS302
Superseded Documents Quality Processes at Eli Lilly and Company
RES-101-4 ver0 Page 8 of 11

4.0 Organization – Roles and Responsibilities, continued

4.2 Quality in Execution
The same roles continue to support computer systems and the quality processes which
use computer systems during execution.
a. Computer System Quality Assurance (CSQA) representatives provide quality
oversight for Global IT computer system maintenance, changes (e.g., vendor
upgrades, enhancements) and IT deviation investigations.
b. Business Quality Assurance (BQA) representatives evaluate proposed computer
system changes for compliance to business quality requirements and advise
CSQA on the impact of computer system deviations on SISPQ. They may
revise global computer system use procedures and best practices and advise
system users as applicable.
c. Site QA representatives are responsible for correct use of GMP computer
systems during execution of the quality business processes in procedures.
4.3 Quality in Monitoring

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Several groups routinely monitor GMP computer systems and their use.
a. Computer System Change Control Boards (CCBs) and Governance Committees
monitor issues, manage changes, and provide oversight for the design and use of
a specific computer system. This group includes the System Owner and the
System Custodian.
b. Computer System Quality Assurance (CSQA) representatives conduct self
inspections and periodic reviews of Global IT computer systems.
c. Global Quality Auditing and Compliance (GQAAC) auditors conduct both
computer system and business process audits. They audit validation
deliverables and compliance with the Quality Standards and Practices. They
also audit suppliers for outsourced computer systems and services, per the
applicable supplier management plan.
d. The Global Quality Systems Team and Site Quality units review quality
systems, including the use of GMP computer systems and global data from these
systems, when conducting local and global Quality System management
reviews.

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 Resource RES-101-4
Version number Document Title Associated GQS
1 GQS101
Effective Date Secondary GQS
01-Jan-2015
Use of Computer Systems to Support GMP LQS302
Superseded Documents Quality Processes at Eli Lilly and Company
RES-101-4 ver0 Page 9 of 11

5.0 Electronic Data Integrity

Business subject matter experts must partner with Information Technology (IT) or the
group responsible for automation to effectively manage and utilize computer systems and
electronic data. Systems are designed, executed, and monitored to ensure data integrity
throughout the record retention period.
5.1 Quality in Design
Electronic record and electronic signature (ER/ES) requirements document what data
and signatures are required to document fulfillment of the predicate rules and current
good manufacturing practices. The computer systems are designed with appropriate
fields, data sets, and audit trails to meet these requirements. They are tested and
validated as part of the computer system validation. The following provide requirements
for data in computer systems.
a. GQS105 – Documentation and Data, describes the types and required content of
GMP data/records, requirements for creating and using executable documents,
when data verification is required, and requirements for storing

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documents/data/records.
b. CQP-105-1 – Rounding Rules and Determination of Decimal Places in Data and
Acceptance Criteria, describes how to determine the correct number of decimal
places to be recorded. This provides requirements when designing fields to
collect data (e.g., LIMS systems).
c. CQP-105-2 – Reporting and Use of Electronic Data, describes the requirements
for developing standard GMP reports.
d. LQS302 – Computer Systems and Electronic Records; Electronic Signatures,
describes the requirements for electronic records and signatures, including
checks during data entry, transfer, and processing, audit trails and system access
and security.
e. LQP-302-24 – Electronic Records; Electronic Signatures, describes the
requirements for validating electronic records and signatures, and
f. LQP-302-10 – Excel Spreadsheet Validation, describes the requirements for
validating Microsoft Excel spreadsheets and macros when they are used for
regulated purposes.

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 Resource RES-101-4
Version number Document Title Associated GQS
1 GQS101
Effective Date Secondary GQS
01-Jan-2015
Use of Computer Systems to Support GMP LQS302
Superseded Documents Quality Processes at Eli Lilly and Company
RES-101-4 ver0 Page 10 of 11

5.0 Electronic Data Integrity, continued

5.2 Quality in Execution
Data must be entered into computer systems accurately and consistently to document
GMP activities and to allow automated interfaces and data extraction tools to operate
correctly. Selected data are combined in integrated data repositories to be available for
data analysis and global trending and metrics. The following documents provide
requirements for entering and managing data in computer systems throughout the record
retention period.
a. CQP-105-3 – Quality and Accuracy of Data Entry into Electronic Systems
provides requirements to ensure that fields are completed accurately, completely
and consistently. CQP-105-3 Attachment A – Associated Resources and Titles,
lists resource documents (e.g., RES-103-1 – TrackWise 215 Change User Guide
and Field Guide) that define how to use specific fields in specific shared
computer systems.
b. CQP-105-2 – Reporting and Use of Electronic Data, describes the business and
IT partnership for designing, monitoring, and using data from source systems

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and integrated data repositories, and
c. LQP-302-6 – Change Control, describes the required controls for data changes
made outside of normal processes (e.g., direct data change using Structured
Query Language (SQL)).
Note: Other LQPs associated with LQS302 provide data integrity requirements for
business continuity, backup and restoration, disaster recovery, and data archival after
system retirement.

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 Resource RES-101-4
Version number Document Title Associated GQS
1 GQS101
Effective Date Secondary GQS
01-Jan-2015
Use of Computer Systems to Support GMP LQS302
Superseded Documents Quality Processes at Eli Lilly and Company
RES-101-4 ver0 Page 11 of 11

5.0 Electronic Data Integrity, continued

5.3 Quality in Monitoring
The global processes and documents used to monitor data integrity are described below.
a. RES-102-2 – Review of Data Changes for Batch Release Associated Records,
describes the process to evaluate which audit trails to monitor when doing batch
release and some standard tools which are available to monitor them.
b. LQP-302-14 – Periodic Review, describes the requirements for periodic review
of computer systems. Data integrity issues may be discovered through review of
system security, issues, risk, or data and system changes in the review period.
c. LQS111 – Quality Auditing, describes auditing and self-inspection processes. It
includes classification and notification of data integrity issues.
d. LQP-101-1 – Notification to Management, lists the data integrity related issues
which require notification to senior management. Attachment B – Notification
Recipients, lists who must be notified for issues related to data integrity.

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6.0 Management of Attachments
Attachments A through E list the global and centrally supported computer systems which
support GMP Quality Processes. They are considered a part of this resource, but they are
managed separately to facilitate revisions. Revisions to the attachments require approval
of a Global Quality Systems Director or Advisor.

Revision History
Version Effective
List of Major Changes
Number Date
Added electronic data integrity section. Updated and added
1 01-Jan-2015
references to new and revised Quality System documents.
0 01-Apr-2012 First version of this resource document.

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