gateway consulting group, inc. 8610 transit road, suite ... · system installation and deployment...

Gateway Consulting Group, Inc. 8610 Transit Road, Suite 100, East Amherst, NY 14051

Telephone: (800) 668-2334 Email: [email protected] http://www.gatewaygroup.com

mailto:[email protected]

GATEWAY CONSULTING GROUP, INC. – EDM SOLUTIONS & SERVICES

Copyright 2016; Gateway Consulting Group, Inc. All rights reserved

WHAT WE DO

Gateway Consulting Group designs and builds Electronic

Document Management (EDM) systems for the chemical,

energy and manufacturing sectors. We excel in business

process improvement scenarios that demand domain

expertise and exceptional information technology skills.

Gateway provides solutions to improve the safety and

efficiency of business processes in highly-regulated

environments:

Electronic Document Vaults Quality Records Management

Capital Project Process Management Design History Files / Records

Management of Change Laboratory / R&D

Incident Reporting & Investigation CAPA

Issue Management Device Master Records

Audit Management Automated Testing & Validation

Our team of professional project managers, analysts and developers are prepared to assist with all aspects

of implementation for the recommended process improvements.

For the past twenty five years we have offered a full range of EDM consulting services:

Engineering / Initial Studies

Requirements Analysis

Business Cases

IT Strategies

Vendor Selection

System Design and Development

System Installation and Deployment

Content Migration

System Testing & Validation

Training and Seminars



FACILEX® SHAREPOINT APPLICATIONS

SharePoint is an Electronic Document Management and

business collaboration platform licensed by Microsoft.

SharePoint has gained recognition as a leading EDM solution

based on its functionality, massive number of users and low-

cost pricing model. SharePoint projects can start small and be

scaled-up for the most demanding enterprise requirements.

SharePoint is a web-based application that offers organizations of all sizes a framework to improve the

efficiency of document-centric business processes. SharePoint can be deployed on-premises to maintain

control and secure management of corporate records.

FACILEX® is a suite of advanced SharePoint configurations designed by Gateway to automate process

safety compliance business processes. Data across all the applications can be aggregated and reported.

These modular lifecycle applications can be rapidly installed on a SharePoint farm to manage:

AUDIT Internal and external audits

CAPA Corrective and preventive actions

INCIDENT Incident reporting and investigation

ISSUES Issue and action Item management

METRIX Metrics aggregation and reporting

MOC Management of change

OMOC Organizational management of change

PHA Process hazards analysis

PROJECT Capital project process management

FACILEX® applications can be easily

accessed through the web browser

on a computer, tablet or smart

phone. Users gain a consistent user

interface across all the applications

that are deployed. Suite licensees can

monitor status across all

applications.



FACILEX® Core

The FACILEX® Core is a common application layer that

runs on top of the SharePoint platform. The

configuration for each application’s lifecycle(s) and

related process information is defined in a set of

SharePoint lists, content types, workflow definitions,

UI configurations, site permissions, etc.

FACILEX® Applications

FACILEX® applications represent simple or complex business processes by rendering them into a number

of states. The collection and sequence of states is termed the lifecycle. FACILEX® applications utilize

different lifecycles depending on the objective of the business process.

The diagrams above illustrate common lifecycle for Management of Change (MOC). During each state in a

lifecycle, participants complete action items. Once all the action items in a state are completed the

business object is promoted to the next state through to Close-out.

One of the key strengths of the FACILEX® applications is that they are entirely configurable, so a company’s

policies, procedures, forms, templates, etc. can be accurately represented in the application. This

significantly reduces a user’s learning curve since they are familiar with the process.

Each of the FACILEX® applications contains a baseline configuration of the applicable business process.

Gateway develops these starting points by carefully studying industry guidelines and creating a

configuration that leverages the applicable standards. Here are some examples.

The Center for Chemical Process Safety, “CCPS” Guidelines

The Project Management Institute

Kepner Tregoe

Stage-Gate International

The ISO-9000 quality system

FACILEXTM Core / WebParts, Workflows, Features, Events, UI Configuration

FACILEXTM/App(s) Schema

Application(s) Data

SharePoint 2010 or 2013



FACILEX® Audit

Organizations are constantly involved in various kinds of

audits. FACILEX® Audit eases the burden of audits by:

Managing the audit protocols

Collecting the data during the audits

Ensuring that the follow-up items are resolved.

Key functionality includes:

Providing a place to store all the “master” audit

protocols or templates

Associating audits with the proper time frame: daily, weekly, monthly, quarterly, annually,

etc. as well as ad hoc audits

Representing audit protocols using technology appropriate to the task: Word® or Excel®

checklists, or FACILEX® “Related Items ”

Being able to create or capture follow-up action items and track these items to completion

Making all the data available for specific and aggregate reporting

FACILEX® CAPA

Corrective and Preventive Actions “CAPA” are used in certain industries to correct actual deficiencies or

anticipate potential deficiencies. CAPAs tend to be quality or product-focused. Corrective and preventive

actions can come from the following causes:

Customer complaints

Internal complaints

Vendor/supplier deficiencies

Corporate directives

Typical CAPA Lifecycle:


Very simple CAPA reports as well as large, detailed CAPA investigations

Determination of root causes, and perhaps “lessons learned”

Escalation to the proper approval level depending on the severity of the problem



FACILEX® Incidents

A key consideration with Incident Reporting and Investigation is the collection of data pertaining to things

like:

Engineering or technical items

Environmental issues

Equipment damage

Fires

Illegal acts

Injuries and illnesses

Line strikes

PSV or control valve discharges

Regulatory/citation issues

Reputation issues

Vehicle incidents

Weather impacts

Typical Incident Investigation Lifecycle:


Collecting the data—but only the necessary data—implied by the list, above.

Objectively assessing the actual severity (what happened) and the potential severity (what

might have happened)

Structuring an investigation, with the level of detail ranging from a simple “one-page” report

to a detailed investigation report

Determining root causes and lessons-learned



FACILEX® Issues

Organizations often maintain “to do” lists for various purposes.

FACILEX® Issues application provides the ability to maintain lists of:

Ideas and suggestions, i.e. corporate “suggestion box”

Follow-up items from various applications

Problems that people have discovered, but for which a

solution isn’t yet known

Ideas for changes, which might be an MOC in the future.

An issue may be addressed by one or more action items that can be

created and assigned right within the Issues application. Alternatively, the issues can be addressed by a

separate business process, like MOC or Capital Project.


Capturing sufficient information about the issue to enable a resolution at some later time

Classifying the issues by department, facility, intended owner, urgency, etc.

Configuring the resolution at the proper level of complexity, all the way from the one-step

resolution to dozens of steps.

FACILEX® MOC

Management of change to facilities (commonly “MOC”) has been a

regulatory requirement for thousands of companies, and a daily

challenge for many more. Key functionality includes:

Advanced checklist functionality, to permit detailed

scoping of all the work needed to complete the MOC

Choice of numerous lifecycles: permanent MOC,

temporary MOC, “short form” MOCs, as well as means

to deal with emergency MOCs

Mechanisms for managing “parent-child” MOCs, such as

when engineering for a change is performed once (the

parent) and implementation of the change occurs at each site (the children)

Ability to track data about items related to MOC: equipment data, hazards analysis, pre-

startup safety reviews



FACILEX® OMOC

Organizational Management of Change (OMOC) to prevent harm to people, processes, and the

environment is an essential part of everyone’s business today. Changes may be in the form of physical

changes to assets or facilities but can also be in the form of organizational changes to personnel or

structural management processes both of which can have immediate and long term impacts that can lead

to increased risk. Changes in job responsibilities, loss of key personnel, or even changes in shift hours can

lead to serious incidents with potentially severe consequences.

Typical OMOC Lifecycle:

Capabilities and key features include:

Initiate a proposed organizational change

Parent/Child relationships to connect related OMOCs

Progressive scoping to identify management system risks and impacts

Layers of Protection (LOPA),

Conduct a risk assessment of the change

Process authorization to implement the change

Assign action items to mitigate the identified risks

Track and close action items

Notify stakeholders of the change and the implementation plan

Verify all the affected documents and systems have been updated

Document close-out of the change



FACILEX® Metrix

There is a great interest in using quantitative feedback from business processes in order to drive

improvements in efficiency and compliance. There are 3-layers of functionality in managing metrics, in

general, and FACILEX® Metrix follows the same logic.

Capture the data: all the data from any FACILEX® application is readily available for

reporting of metrics.

Aggregate the data across multiple applications, across multiple sites: FACILEX® provides

a “Statistical Reports” capability to bring the relevant data together in a single location to

speed up reporting and executive dashboards.

Present the data: FACILEX® exports to standard graphics tools—ranging from Excel, to

advanced intelligence applications.

Metrics can be summarized in dashboards to support many common programs, like API 754, Risk-Based

Process Safety, and so on.



FACILEX® Project

Many companies have improved their ability to manage capital projects by instituting formal

methodologies. Often, these methodologies are based on a phased business process such as the one

illustrated in the Capital Projects Lifecycle below.

This type of capital project procedure can be easily configured in FACILEX® to automate the process of

managing the capital project.


Ability to configure the project lifecycle to match the project management methodology

Management of all the in-process documentation

Ability to configure multiple lifecycles to accommodate everything from very small

projects, to very large projects

Links to other FACILEX® objects, like MOCs

Action item tracking

Utilize existing forms and templates

From an engineering and construction perspective, a lot of the time on the project is spent on planning,

updating documents, and status tracking events. SharePoint offers a rich set of reporting features for

presenting capital project management data and trends.

Gateway provides the expertise for managing the huge amount of

technical information associated with any major capital project. This is

a surprisingly difficult data management problem. The challenge for

large capital projects is to prevent the loss of valuable design and as-

built information provided during the life of the project.

Gateway’s capital project document management solution provides a

common document repository and the business processes for

managing the flood of information that comes in during the design,

build and integration phases of the project. The content is accessible in

several different views to accommodate the needs of engineering,

construction and operations.



Process Safety Information (PSI) Vault

Gateway's PSI Vaulting Solution provides a consistent approach for managing Process Safety Information

to insure regulatory compliance and audit readiness including:

Hazards of the highly hazardous chemicals in the process

Technology of the process

Equipment in the process

Recognized & Generally Accepted Good Engineering Practice

FACILEX® PHA

The FACILEX® Process Hazards Analysis (PHA) application begins from an enterprise perspective:

Regions, Area, Units (using client terminology) are supported

Equipment lists can be downloaded from common maintenance and asset management

systems, like SAP®, Maximo®, and others,

Equipment can be categorized as “equipment”, “safety systems”, “instrumentation”,

“lines”, “wires”, and other categories of the client’s choosing

Each equipment item can be linked to one or more PHAs

This permits answering the currently most difficult PHA question, and that is

determination of which PHAs a specific equipment item is covered on

Common PHA techniques are supported, including checklist analysis, What-if Analysis, What-if/Checklist

analysis, HAZOPs, etc. PHAs can be stand-alone items, or linked to MOCs and Capital Projects. Follow-up

items are automatically tracked as well.

Voluntary Protection Plan Portal

Gateway can rapidly configure a SharePoint portal to consolidate all the elements for managing VPP

program compliance and audit readiness including:

Management & Employee Commitment

Program Description & Announcements

Injury/Illness Rate

Management & Employee Participation

Worksite Analysis

Hazard & Control

Incident Reporting & Investigation

Safety Risk Assessment

Safety & Health Training



ELECTRONIC DOCUMENT MANAGEMENT (EDM) PROFESSIONAL SERVICES

Gateway has been engaged by clients in industrial sectors such as discrete manufacturing, chemical

process and petroleum refining to provide consulting services for:

Engineering Studies

Requirements Analysis

Business Cases

Vendor Selection

System Design

System Deployment

Content Migration

Testing and Validation

Seminars and Training

Engineering Study

An EDM platform provides a foundation for the management of a wide range of digital content. An EDM

platform can be implemented that will scale up to meet the demands of large, global corporations. An

enterprise-wide, electronic document management project is an initiative that demands deep skills in

project management, communications and information technology. The first step in a large EDM project is

to conduct an Engineering Study. The Engineering Study defines the target locations, business processes,

documents and data in the scope of the EDM project and provides an estimated budget for all aspects of

software, hardware and services that will be required and a project schedule.

Gateway assigns highly qualified consultants to lead the interview and data collection activities that take

place at the client’s site. This activity requires an extensive background in the core business processes that

are conducted by the client and a deep understanding of the document and data management issues that

would be typically encountered. Gateway also conducts an assessment of the current IT infrastructure for

opportunities to leverage existing investments and gauge the effort involved in migrating content from any

applications targeted for replacement.

Gateway’s Engineering Study Report takes a position on the topics outlined above complete with an

executive summary, observations, conclusions and recommendations. Gateway assists as required to

present the information to the client’s project review or steering committee.



Requirements

An electronic document management initiative is usually launched to satisfy a wide range of requirements.

In order to ensure the goals for the EDM project are achieved, the requirements should be written down. A

Requirements Analysis is undertaken to define "what" is needed in order to improve business processes

and achieve the organization's vision for productivity and growth. The process of documenting

requirements is invaluable because it enables a project team to establish a common understanding of the

unique business process and content management needs for their organization. They describe typical use

case scenarios, process workflows and communicate areas of focus for improvement. Documented

requirements are essential for an FDA regulated EDM solution. A requirements document allows an

organization to communicate their unique goals to solution vendors. Lack of, or inadequate requirements

are a major cause of IT project failures.

Gateway assigns highly qualified consultants to lead the interview and data collection activities that take

place at the client’s site. This activity requires an extensive background in the core business processes that

are conducted by the client and a deep understanding of the document and data management issues that

would be typically encountered.

Gateway would carry out the system modeling activities appropriate for the project with an emphasis on

simplicity and readability. The models, include mock-ups, screen shots, diagrams, etc., rapidly provide the

key stakeholders with an understanding of the functions and features that would be included in the new

application and the ability to provide their input early on in the project.

Gateway’s Requirements Analysis report would take a position on the topic of system performance,

boundaries, grouping, prioritization, complexity, risk complete with an executive summary, observations,

conclusions and recommendations. Gateway would assist as required to present the information to the

client’s project review or steering committee.

Business Case

An electronic document management project requires a substantial expenditures of manpower and

financial resources. A Business Case may be required to demonstrate to management the financial viability

of the project, and can be an important factor in obtaining funding for a project.

In most cases EDM projects are implemented to improve the efficiency of an existing business process.

Both the costs and benefits are considered when making the financial analysis.

Experience has taught us that funding a major IT initiative is a process, rather than an event. As such, it is

usually necessary to set cost expectations early, and then refine the cost information as the project

progresses.



Vendor Selection

An electronic document management project typically requires that a Commercial-Off-The-Shelf ("COTS")

software platform be purchased, configured and implemented. Gateway can assist with initial selection

criteria and develop a Request For Information ("RFI") document. Gateway can also assist a project team

by leading a consistent information gathering and evaluation process.

System Design

During System Design the work to determine "how" to satisfy the requirements takes place. Gateway can

rapidly model the EDM solution in sufficient detail to allow a project team to understand how their

requirements will be met.

The design may be expressed in words and diagrams as a specification, or may be accomplished with

screen shots, mockups or prototypes. At the conclusion of the system design the major building blocks for

the solution are defined:

Information representation: object types, indexing, grouping

Business process representation: e.g., dashboards, lifecycles, workflows, reports, etc.

Core functions: e.g. search, check in/out, revision control, security, etc.

Application specific functions: e.g. forms for data entry, integrations, e-signature, etc.

System architecture: e.g. servers, desktop tools, vaulting, network

System Development

Gateway can provide a highly-qualified development team to assist in implementing an electronic

document management system. EDM solutions are built on software platforms that require configuration.

Although out-of-the-box modules are available for many popular applications they do require varying

degrees of configuration for the intended business processes.

The complexity and skill levels required for development rise sharply when the tools are integrated with

applications such as CAD or ERP. Gateway can assist in leading an EDM development initiative with:

A well-disciplined software configuration management process

A comprehensive test and remediation program

A disciplined approach to managing issues that arise with the software suppliers

System Deployment

An EDM deployment typically requires the installation of several software component products. The

baseline software installation process is not a one-time event. In order to deploy a production system, the

baseline will usually need to be replicated on test and quality systems as well. Gateway has a wealth of

experience in assiting project teams with procedures and tools to:

Reduce the effort to create each new installation

Maintain uniformity between development, test and production systems



Content Migration

An electronic document management project may require data to be extracted from a legacy system and

uploaded into the new system. The level of effort required to conduct the content migration is often under

estimated. Gateway can assist a project team to prepare and carry out all aspects of Content Migration,

including:

A content extraction process for the files, objects, attributes, and relationships moving

out of the legacy system and development of any data extraction tools and/or scripts

A content load process for uploading data into the new system and development of any

data load tools and/or scripts

A content test and remediation process to protect the integrity of the extracted files,

objects, attributes, and relationships

Validation

Gateway is highly qualified to assist a project team in creating the documented evidence required by

medical device manufacturers to comply with both the technical and procedural aspects of the US Food

and Drug Administration (FDA) 21 CFR Part 11 and 21 CFR Part 820.

MOC Best Practices Seminar

In this six-hour seminar Dr. Rainer Hoff shares Gateway's methodology for analyzing MOC processes. The

program provides insight on how to identify and eliminate the bottlenecks and wasted effort that slows

down most MOC processes. The best practices and process improvement guidance provided in this

seminar are applicable to an existing paper-based or electronic MOC process. The seminar describes over

50 best practice techniques and tips to optimize the MOC process. The domain expertise offered in this

program has been developed during the course of hundreds of projects conducted by Gateway over the

last twenty years. The typical MOC Best Practices Seminar Agenda includes:

Basic Concepts

MOC Best Practices

Successful MOC Initiatives



ABOUT US

Gateway has focused on providing Electronic Document Management expertise to engineering,

manufacturing and process industries since 1991. We can trace our roots back to a document

management research project sponsored by the University of Waterloo, Canada during the 80’s. Back then

the term Electronic Document Management hadn’t even been coined. Over the years we have focused

our activities and therefore continued to grow our expertise in chemical process and energy sector

applications as well as life sciences applications: medical devices, pharmaceutical and biotech. All Gateway

projects are led by one of our Senior Principal Consultants:

Rainer Hoff, Ph.D., P. Eng.

Dr. Hoff is President and a Senior Principal Consultant for Gateway Consulting Group, Inc. and was Chair,

AIChE Global Congress on Process Safety 2015. He is an authority on the use of Electronic Document

Management technology to solve challenging information management problems. He has devoted over

twenty five years of study to business process optimization in the energy and life sciences sectors. He is

the author of the Management of Change (MOC) Best Practices Newsletter and produces and presents the

educational seminars: Electronic Document Management, Chem NEP Readiness and Management of

Change Best Practices.

Darrell Raymond, Ph.D.

Dr. Raymond is a Senior Principal Consultant at Gateway and has been with the company since 1996. He

has a strong research background in several areas of computer science, including databases, authorization,

and Electronic Document Management systems, as well as many years of practical experience in

requirements, architecture, systems design, implementation, and rollout. Dr. Raymond can be credited

with the leadership of several of Gateway’s largest and most successful projects. His industry domain

expertise extends across discrete manufacturing, process and life science industry sectors.

Raimund Laqua, P. Eng. PMP

Mr. Laqua is a Senior Principal Consultant at Gateway and has been with the company since 1994. He is an

authority on the use of Electronic Document Management in the highly-regulated life sciences and energy

sectors. Gateway relies on Mr. Laqua for IT system architectures, IT strategies, development of

requirements, product evaluations and all aspects of EDM project management. Mr. Laqua is highly

experienced in deploying EDM solutions for engineering, capital projects document management and

process safety information management. Mr. Laqua has led several of Gateway’s recent EDM deployments

focused on Management of Change, Incident Management and Action Item Management.



CONTACT US

Head Office Address:

Gateway Consulting Group, Inc.

8610 Transit Road, Suite 100,

East Amherst, NY 14051 USA

Phone: (716)636-0200

Directions from BUF Airport:

East on Genesee St./RT-33 for 1.6 mi.

North on Transit Rd./RT-78 for 4.4 mi

8610 Transit Rd is on the left

Mapquest: http://mapq.st/RUjWjl

Direct sales inquiries to:

Gordon Blake

Director, Business Development

Gateway Group, Inc.

1206 - 20 Erb St. W,

Waterloo, ON N2L 1T2 Canada

Phone: (519)746-9800 x 221

Email: [email protected]

Web Site: www.gatewaygroup.com

Mapquest: http://mapq.st/1agJO6y

http://mapq.st/RUjWjl

mailto:[email protected]

http://www.gatewaygroup.com/

http://mapq.st/1agJO6y

gateway consulting group, inc. 8610 transit road, suite ... · system installation and deployment...

Documents