Whitepaper

Why You Should Start with

Document, Training and
Change Management as
The Building Blocks for
Your QMS
 EDMS Before EQMS - Why?
Companies, as part of their digital transformation, embrace Enterprise
Quality Management Systems to help migrate from paper based,
be-spoke/non-integrated systems to a unified platform providing
capabilities to automate key QMS processes across the organization. As
such, the question often asked is, which solution(s) should I start with? The
typical consultant response would be, “Start with where you believe the
maximum pain for the organization is and evolve from there”. This
approach makes perfect sense if the focus was to solve a specific problem
that the organization faces. However, to effectively implement a new
Quality Management system, it is important for an organization to identify
and build the right foundation first and then build the rest of the QMS on it.
This approach will not only solve the problems that the company faces in
the right model but also provide an approach to roll-out a strategy that is
sustaining, well adopted and is longer lasting.

ComplianceQuest strongly recommends the roll-out of Enterprise Document Management System

(EDMS) consisting of Document Control, Training and Change Management processes as the
foundational capabilities first. The following provides the salient points to consider:

1. If you work in Quality you probably know that the effectiveness of a Quality Management System (QMS)
relies extensively on enterprise-wide collaboration and begins with a solid process for managing
critical/important documents, such as standard operating procedures. As rapidly as business and its
processes evolve these days, many organizations struggle to stay current in a sea of change. Therefore,
it’s not surprising that document management remains at the very top of quality management processes
being automated especially within highly regulated industries

Are you interested in getting a Document, Training and Change

Management System that is fully validated? If yes, then you have come to
the right place. See how ComplianceQuest Document, Training and
Change Management Solutions can optimize your business processes and
turn your company into a successful empire.

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2. LNS Research, a leading EQMS focused independent analyst organization, states:

a. Today, document management is a typical functionality of enterprise quality management

software (EQMS). Because many EQMS functionalities require standardized documents and
workflows, document management software is a key enabler of closed-loop quality
management, the concept of creating cross-functional quality data feedback loops to earlier
in the value chain. Specifically, document control plays a noteworthy role in improving the
following processes:

Audit
Change
Environment, Health, & Safety (EH&S)
Non-conformance/Corrective and Preventive Action (NC/CAPA) management
Deviation (Temporary or Planned)
OOS/OOT
Supplier Quality
Compliance
Employee Training

b. Quality professionals recognize that conformance and harmonization of an enterprise Quality

Management System (QMS) begins with a solid document management foundation. But the
reality is, most organizations are drowning in documentation—which is why there’s no
surprise that document management remains at the very top of quality management
processes that have been automated by organizations. Such capabilities in enterprise quality
management software (EQMS) are commonplace, often tightly coupled with training and
competence feature-sets, providing an escape from the stagnant and difficult-to-maintain
multiple binder, shared directory or 1-dimensional intranet page approach. Four primary
considerations:

Speed and ease of access and consumption for document stakeholders

Ensuring the integrity of documentation
Automating onerous tasks associated with publishing and distributing documents
Leveraging for multiple disciplines as a business operating system

c. Approximately 47% of companies surveyed by LNS Research indicated that they had
adopted an electronic Document Management System (eDMS) to enhance and expedite
their quality processes. Clearly, there’s plenty of room for improvement in this area among
industries where quality is key. Incessant changes and modifications, combined with industry
regulations requiring document management, make it nearly impossible to maintain a
structured, accurate quality management system without an automated process.

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3. Responsible for regulating and controlling crucial systems, processes, functions, and procedures,
documents drive nearly every action within a Life Sciences company. By starting with document
management when moving to digital, organizations will have a repository of all objective evidence and
proof surrounding end-to-end product lifecycle process. Searching for and finding the latest version of
documents quickly is key. This is critical for compliance for all Regulatory Inspections and ISO
Certifications.

4. Strong document management processes ensure everyone in your organization, regardless of the
department or team, knows exactly where a document is housed, which stage it’s at in the review
process, and has access to documents quickly. A document is useless, if it’s not accessible when needed
by the people who need them.

5. Documents are on-going living entities continually changing as the organization, process and products
change vs. records that reflect history of what has happened. Keeping control of documents in
paper-based environment can make this complex in making sure to get all the appropriate reviews and
approvals and ensuring employees are using the right version of documents in their job whether in
Quality, Manufacturing shop floor, or Customer Service complaint handling.

6. Companies that have embraced EQMS as their priority before solving EDMS have indicated that
implementing EQMS is viewed as a partial automation of a specific process considering most problem
related processes one way or the other come back to tackling changes to a document or re-training a
specific set of resources that was involved in the problem to begin with.

7. “Documented information required by the quality management system and by this International Standard
(ISO 9001) shall be controlled.” The whole point of controlling documented information is to make sure it
is “available and suitable for use” and also “protected.” Being able to clearly show custody and traceability
of documents is a regulatory requirement, and EDMS can help us comply through the use of audit trails
and traceable and granular security controls.

We have just migrated our change, complaint, audit and document

management system onto the eQMS provided by ComplianceQuest.
ComplianceQuest has given excellent support in providing
customization to our specific QMS requirements and sustained
guidance through the entire migration and integration process. We
are receiving excellent feedback from the users on the interactive
and easy-to-use interface. Data analysis & review and cross-
functional collaboration can be done in real-time which has really
enhanced our QMS. Highly recommended!
-Manager QA & Management Representative, CEAT Ltd

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8. Paper document management and archiving can be very labor intensive and expensive, given the long
record retention requirements for regulated content in the life sciences. Processing, storing and
retrieving documents can be significantly improved when moving to electronic environments.
Automated document retention policies improve archiving processes. The need for physical storage
space for paper records is also significantly reduced or eliminated altogether.

9. Document content and metadata can represent a significant part of a company’s intellectual property.
Being able to generate metrics and trends from this data is possible through business intelligence and
advanced search tools available in an EDMS. Being able to easily find information and knowledge from
indexed content allows for improved decision making and reduces the amount of time lost looking for
information.

10. An effective automated system will integrate document and change control procedures. It also will
integrate with other solutions, providing access to approved, controlled documents in other areas of the
quality system, including audits, CAPAs and employee training. In these cases, an automated system’s
search and retrieval capabilities, dashboards, and repositories expedite the processes.

11. Operational excellence and compliance are dependent upon accurate data and real-time document
management. Although the change from paper-based or hybrid systems to a fullyautomated system is a
challenging one, recent regulations and scrutiny on product safety is making the transition necessary.
Companies that use automated systems report quick return on investment through expedited and
effective document control that drives overall enhanced conformance and harmonization of quality
systems at the enterprise level.

QUALITY AND COMPLIANCE

KEY QUALITY
SOURCE INPUTS

MANUFACTURING
EQUIPMENT
MANAGEMENT

INSPECTION
MANAGEMENT CONTINUOUS
MONITORING
SUPPLIER
MANAGEMENT AUDIT
MANAGEMENT
QUALITY AND COMPLIANCE FOUNDATION
ENVIRONMENTAL & TRAINING/SKILL
SAFETY INCIDENTS MANAGEMENT
CHANGE
CUSTOMER MANAGEMENT
SERVICE DOCUMENT
MANAGEMENT
COMPLAINTS/
ADVERSE EVENTS
QUALITY PULSE
FIELD SERVICE
EVENTS EVENTS
(NC, CAPA)

PRODUCT QUALITY
LABORATORY

OOS DESIGN CONTROL

PRODUCT DATA
AND OTHERS… MANAGEMENT

RISK
MANAGEMENT

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 12. A robust Document Control process lies at the heart of a Quality Management system. Nearly every
element of auditing and compliance is verified by examining documented evidence. That’s the regulatory
inspectors’ bread and butter, so to stay compliant, you need to keep your organization’s documents fresh
and handy.

13. The use of contract manufacturers has grown, and today's supplier relationships have expanded in global
reach and material/component complexity. As a result, the need for collaborative workspaces and
effective version control have become paramount to ensure valid, safe, and legal operations.

14. A well designed, documented system has many benefits, it ensures quality standards are routinely met,
minimizes the potential for error, reduces downtime when deviations occur due to being able to quickly
access relevant data, and allows for easy monitoring of the processes such that process outputs are
analyzed and appropriate adjustments are made. QMS documentation fulfills many functions such as
communication of information, providing evidence of conformity and sharing knowledge and as such
many different types and levels of documents are needed, for example a quality manual, quality policy,
documented procedures and work instructions.

15. Documentation is also required for regulatory purposes and must demonstrate the effective planning,
operation and control of the organization’s processes and the implementation and continual
improvement of the effectiveness of its QMS. It is evident that good documentation is critical to a
functioning QMS, in fact it forms the foundation of the organizations QMS as it gives effect to the QMS
for the life-cycle of the product/service being delivered.

CONCLUSION
In conclusion, the above white paper outlines the significance of why EDMS is
considered “foundational systems” for a robust enterprise wide adoption of a
digital QMS platform and argues why implementing it first will help companies lay
the foundation to build on.

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About ComplianceQuest
Transform to a fully connected business with a next-generation AI-Powered Product, Quality and Safety
management platform, built on Salesforce. Our connected suite of solutions helps businesses of all sizes
increase quality, safety and efficiency as they bring their products from concept to customer success. Our
intelligent data-driven platform comes with best-in-class integrated processes to mitigate risks, protecting your
employees, suppliers and brand reputation, and to increase innovation, compliance, profit and customer loyalty.
ComplianceQuest is pre-validated and easy to implement, use, and maintain, allowing for streamlined
communication and collaboration across the product value chain.

For more information, or to request a demo with a ComplianceQuest expert, contact ComplianceQuest today:

• Visit
• Email us at [email protected]
• Call us at 408-458-8343

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