Document Management - White Paper (ID 5277).pdf Jul. 2014 | Page 37

Compliance Issues
For organizations that must meet compliance requirements
associated with regulations, laws, industry standards or
certification, an additional set of overriding concerns will factor
into the selection process.

Overall, requirements for document management system in a
regulatory environment frequently include:
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Legal.
Some organizations face significant exposure to civil or criminal
liability associated with non-compliance. In these cases, a
document management system helps ensure processes and
procedures are strictly followed, in addition to capturing and
maintaining a verifiable record of user actions and past versions.
History logs provide evidence of compliance when and if an audit
or compliance-related issue arises.

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The DMS can prove indispensible for enforcing proper procedures
and greatly speed reporting and audits. However, bear in mind
that technology solutions are only aids to compliance; no system
alone can ensure complete compliance since it is the organization
that must implement processes and follow them.
Certification.
Other organizations in the engineering, product development,
and/or manufacturing sectors may voluntarily seek certification
from a third party that oversees industry standards or international
compatibility requirements.

Elimination of paper records
Increasingly, scanned document images are legally acceptable
and organizations may not have to retain paper originals. A legal
expert can provide the specifics for the industry or jurisdiction
in question. There are, however, certain common requisites
concerning moving from paper records to an electronic document
management system:
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As with legal records, ensuring that required procedures
were followed and associated corroborating documentation
was maintained becomes of critical importance. A document
management system can assist with not only achieving
certification, but do so in a much more efficient and cost-effective
manner.

Precisely mandated reporting formats and media
Unalterable recording formats
Transfer capability for a specific set of records to a third
party
Controls against data loss, tampering, or privacy breach
Flexible cross-referencing with other indexed systems
Proper instructional manuals describing software functionality and customizations
On-demand and secure retrieval, including secure access
and retrieval from remote location

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Electronic versions of documents should reside in
unalterable storage formats (e.g. DVD)
Effective controls against data loss, deterioration, tampering,
or deletion
Audit measures to detect and identify the source of
unauthorized file handling
Ability to accurately and completely transfer and/or copy all
documents and related metadata
An indexed system for document retrieval
Explanatory materials for others to use the document control
system

Time stamps and format.

Compliance Considerations by Industry

Regardless of the governing agency involved, two common
requirements of compliance and standardization are particularly
well suited for electronic document management tools:

Financial services
Any firm that handles the finances of others is subject to scrutiny
both in terms of protecting client privacy and the consistency
of funds handling. To ensure accountability, the Securities
and Exchange Commission (SEC) requires firms to index all
transaction documentation by date and user and store the
records on unalterable media.

First, information collected must be “time-stamped” with key
milestones such as the date of creation or dates of review and
approval. These records should also include the individuals who
prepared, reviewed, and approved the associated documents.
Second, each version remains preserved with key time-stamps
and electronic signatures of the individuals involved in unalterable
media format, for example, DVD-ROM. In the financial world, this
“unalterable” clause often also includes an independent third party
who maintains a library of duplicate records which auditors can
cross-reference.

In many cases of document management system implementation, compliance officers can speak directly with the vendor to get
a thorough explanation of compliance requirements for auditing.

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EASY DOCUMENT MANAGEMENT