Overview of Records Management. Records management (RM) is the practice of maintaining the records of an organization from the time they are created up through their eventual disposal. This presentation walks through the key drivers, records management adoption issues, policy alignment and the cloud.
2. 1. Records Management: Definition and Level Set
Records management (RM) is the practice of maintaining the records of an organization
from the time they are created up through their eventual disposal.
These activities include:
o Identifying;
o Classifying;
o Storing;
o Tracking and auditing;
o Securing and holding, and;
o Disposing via destruction or archiving the record.
A record can be either electronic information or a tangible physical object. Examples
include regulatory documents, IP-related documents, corporate documents, office
documents, databases, application data, voicemail recordings, social media data and e-mail.
A record is differentiated from a non-record by its relevance and importance to the
organization’s business continuity, business operations, internal and external compliance
needs, regulatory requirements and support for legal activities.
3. 2. Key Records Management Drivers: The Why’s
We have seen the following six areas used as the business drivers for most RM
efforts:
1. Improve litigation performance and reduce costs
o eDiscovery efficiency improvement
o Reduction in court fines and judgments
2. Business Continuity / Disaster Recovery
3. Compliance with statutes and legislation
o Federal Rules of Civil Procedure [FRCP 26(b)]
o HIPAA
o MA 201 CMR 17.00
4. Compliance with industry regulations & guidelines
o 21 CFR Part 11
5. Exploitation of internal information and knowledge resources
o Integration with ECMS and Cloud content program efforts
o Knowledge management
6. Reduction in storage costs
o Physical and electronic
o Onsite and offsite
4. 2. Key Records Management Drivers: The Why’s, cont.
There has been an exponential increase of potentially discoverable content during the
past 5 years.
What makes this new situation difficult is:
o The vast majority of company ‘information’ is now unstructured, outside of the RDBMS
and business transaction control structures.
o Much of the unstructured content is also outside of the direct awareness of leadership.
o Some of the unstructured content is stored with third-party vendors…and they have
their own rules of managing your content.
This content didn’t exist
in most companies 5
years ago.
Source: Symantec 2013 Business Survey.
5. 2. Key Records Management Drivers: The Why’s
Content and records well
managed and controlled
($)
Not so much...
($$$)
6. 2. Key Records Management Drivers: The Why’s, cont.
The Information Governance model is absolutely key
to preparing for a successful RM environment.
A few best practices:
o Policies need to be integrated. For
documents, social media, email, etc.
o A good information governance model can
support RM and Enterprise Content
Management initiatives.
o Extreme content value can be derived from
RM, but it needs to be planned into the
processes.
Source: EDRM.net
7. 3. The Top Three Reasons for Lack of RM Adoption are…
In a recent poll, the top three reasons for lack of RM Adoption are:
1. No commitment at the board- or C-level
2. No investment monies committed to the RM program effort
3. Inability to obtain an agreement amongst leadership and across
departments
Which highlights a few important questions that sometimes don’t get
answered early in the RM project…but should:
o Who ‘owns’ the RM problem and the RM project?
Legal, IT, Compliance, Risk Management or Audit?
(Might it depend on how RM is approached and its objectives?)
o Can RM, on its own costs and merits, stand as its own project for the
long-term?
o What is IT’s role in leading and supporting an RM initiative?
o What value does the ‘average’ user in the ‘average’ company
department get from RM? i.e. “W.I.I.F.M.”
An interesting note…
o According to 52% of surveyed organizations, RM would reduce legal
costs by 25% or more if implemented.
8. 4. The Heart of RM: The RM Policy and Retentions Schedule
Considerations for creating the RM Policy and Retentions Schedule:
Project Cost ∝ Complexityn of the RM Policy and Schedule. (n>>1)
o The complexity of the policy and schedule exponentially drives cost of design
and implementation.
o Simplify retention periods, aggregate content types and reduce the number
of trigger events to save design and implementation effort. Use “Big
Buckets.”
Define your Technology Budget and Design your Policy and Schedule
Accordingly
o Understand the technical and functional limitations of your chosen
technology (e.g. SharePoint, Symantec Vault, LiveLink, etc.) prior to finalizing
your Policy and Schedule. Keep it real. Customizations are very expensive.
o A ‘good’, implemented RM approach is much better than a ‘perfect’, un-
implementable system. Again, use “Big Buckets” approach.
Ensure your Cloud Providers Play by your Rules (or at least know theirs)
o The retention timeframes of social media cloud vendors (e.g. Jive) vary.
Many retention timeframes are not controllable by the customer. Be aware
of your Cloud vendors rules and limitations.
o Don’t be caught off guard by an eDiscovery request years from now that
could look at today’s social media content.
ID Record'Type
Vital'
Record
Data
DMPK%001 Raw%Internal Regulated Yes
DMPK%002 Raw%External Convenience No
DMPK%003 Processed Regulated Yes
DMPK%004 Analyzed Regulated Yes
DMPK%005 Guidelines Regulated Yes
DMPK%006 Manual Regulated Yes
DMPK%007 Method'Development Convenience Yes
DMPK%008 Pictures Convenience Yes
Example'Retention'Schedule
Record Series Title
Example'DMPK'&'AP
Trigger'Event
Retention'Period'
Start'Date
Retention'
Period'Length
Retention'
Units
Action'at'end'of'
Period
Disposal'
Scope
Media'
Type Notes Legal'Citation
Start/EndJofJLitigation UponJTriggerJEvent 4 Months Destroy Backup Both
Start/EndJofJHold TEJ+JEndJofJMonth Indefinate N/A Archive AllJCopies Both
Start/EndJofJHold TEJ+JEndJofJMonth 3 Years Destroy AllJCopies Electronic
Start/EndJofJHold TEJ+JEndJofJYear 20 Years ReviewJByJOwner Backup Electronic
Start/EndJofJHold UponJTriggerJEvent Permanent N/A ReviewJByJOwner Primary Electronic
Start/EndJofJLitigation UponJTriggerJEvent 7 Years Destroy AllJCopies Electronic
AuditJCompletion TEJ+JEndJofJQTR 15 Years Destroy Backup Electronic
TerminationJDate TEJ+JEndJofJMonth 18 Months Archive Primary Electronic
Example'Retention'Schedule
Procedure Regulated Yes
DMPK%009 AnalyteJLC%MS Regulated No
DMPK%010 ClinicalJSampleJProcessing Regulated
DMPK%011 ExtractionJAnimalJMatrix Regulated
DMPK%012 Robot Regulated
Protocol Convenience
DMPK%013 Clinical Regulated
DMPK%014 Investigative Regulated
DMPK%015 MethodJDevelopmentJ Convenience
Report Regulated
DMPK%016 AntigenicityJJJ Regulated
DMPK%017 Metabolism Business
DMPK%018 PD Regulated
DMPK%019 PharmacokeniticJJJ Regulated
DMPK%020 PKJJ Business
DMPK%021 QAJNon%StudyJSpecificJAuditJJ Regulated
DMPK%022 StudyJSpecificJAuditJ Regulated
DMPK%023 Certificate'of'Analysis'(CoA) Regulated
SOP Business
DMPK%024 AnalyticalJValidationJMethodsJJ Business
DMPK%025 ChangeJControlJDocumentation Convenience
DMPK%026 SystemJValidationJandJDecommisionConvenience
DMPK%027 Summary Business Yes
Record'Type
Vital'
Record
Regulated No
Managed'Vocabulary'Options'/''Selection'Choices'for'the'Chart'Above.
SubmittedJDate UponJTriggerJEvent 6 Years ReviewJByJOwner AllJCopies
Start/EndJofJHold TEJ+JEndJofJMonth Indefinate N/A ReviewJByJOwner Primary Electronic
SubmittedJDate TEJ+JEndJofJQTR 7 Years Destroy All Electronic
Trigger'Event
Retention'Period'Start'
Date
Retention'
Period'Length
Retention'
Units
Disposal'Action'at'
end'of'Period
Disposal'
Scope
SubmittedJDate UponJTriggerJEvent 1 Days ReviewJbyJOwner Primary
Managed'Vocabulary'Options'/''Selection'Choices'for'the'Chart'Above.
ID Record'Type
Vital'
Record
Data
DMPK%001 Raw%Internal Regulated Yes
DMPK%002 Raw%External Convenience No
DMPK%003 Processed Regulated Yes
DMPK%004 Analyzed Regulated Yes
DMPK%005 Guidelines Regulated Yes
DMPK%006 Manual Regulated Yes
DMPK%007 Method'Development Convenience Yes
DMPK%008 Pictures Convenience Yes
Example'Retention'Schedule
Record Series Title
Example'DMPK'&'AP
Trigger'Event
Retention'Period'
Start'Date
Retention'
Period'Length
Retention'
Units
Action'at'end'of'
Period
Disposal'
Scope
Media'
Type Notes Legal'Citation
Start/EndJofJLitigation UponJTriggerJEvent 4 Months Destroy Backup Both
Start/EndJofJHold TEJ+JEndJofJMonth Indefinate N/A Archive AllJCopies Both
Start/EndJofJHold TEJ+JEndJofJMonth 3 Years Destroy AllJCopies Electronic
Start/EndJofJHold TEJ+JEndJofJYear 20 Years ReviewJByJOwner Backup Electronic
Start/EndJofJHold UponJTriggerJEvent Permanent N/A ReviewJByJOwner Primary Electronic
Start/EndJofJLitigation UponJTriggerJEvent 7 Years Destroy AllJCopies Electronic
AuditJCompletion TEJ+JEndJofJQTR 15 Years Destroy Backup Electronic
TerminationJDate TEJ+JEndJofJMonth 18 Months Archive Primary Electronic
Example'Retention'Schedule
Procedure Regulated Yes
DMPK%009 AnalyteJLC%MS Regulated No
DMPK%010 ClinicalJSampleJProcessing Regulated
DMPK%011 ExtractionJAnimalJMatrix Regulated
DMPK%012 Robot Regulated
Protocol Convenience
DMPK%013 Clinical Regulated
DMPK%014 Investigative Regulated
DMPK%015 MethodJDevelopmentJ Convenience
Report Regulated
DMPK%016 AntigenicityJJJ Regulated
DMPK%017 Metabolism Business
DMPK%018 PD Regulated
DMPK%019 PharmacokeniticJJJ Regulated
DMPK%020 PKJJ Business
DMPK%021 QAJNon%StudyJSpecificJAuditJJ Regulated
DMPK%022 StudyJSpecificJAuditJ Regulated
DMPK%023 Certificate'of'Analysis'(CoA) Regulated
SOP Business
DMPK%024 AnalyticalJValidationJMethodsJJ Business
DMPK%025 ChangeJControlJDocumentation Convenience
DMPK%026 SystemJValidationJandJDecommisionConvenience
DMPK%027 Summary Business Yes
Record'Type
Vital'
Record
Regulated No
Managed'Vocabulary'Options'/''Selection'Choices'for'the'Chart'Above.
SubmittedJDate UponJTriggerJEvent 6 Years ReviewJByJOwner AllJCopies
Start/EndJofJHold TEJ+JEndJofJMonth Indefinate N/A ReviewJByJOwner Primary Electronic
SubmittedJDate TEJ+JEndJofJQTR 7 Years Destroy All Electronic
Trigger'Event
Retention'Period'Start'
Date
Retention'
Period'Length
Retention'
Units
Disposal'Action'at'
end'of'Period
Disposal'
Scope
SubmittedJDate UponJTriggerJEvent 1 Days ReviewJbyJOwner Primary
Managed'Vocabulary'Options'/''Selection'Choices'for'the'Chart'Above.
ID Record'Type
Vital'
Record
Data
DMPK%001 Raw%Internal Regulated Yes
DMPK%002 Raw%External Convenience No
DMPK%003 Processed Regulated Yes
DMPK%004 Analyzed Regulated Yes
DMPK%005 Guidelines Regulated Yes
DMPK%006 Manual Regulated Yes
DMPK%007 Method'Development Convenience Yes
DMPK%008 Pictures Convenience Yes
Example'Retention'Schedule
Record Series Title
Example'DMPK'&'AP
Trigger'Event
Retention'Period'
Start'Date
Retention'
Period'Length
Retention'
Units
Action'at'end'of'
Period
Disposal'
Scope
Media'
Type Notes Legal'Citation
Start/EndJofJLitigation UponJTriggerJEvent 4 Months Destroy Backup Both
Start/EndJofJHold TEJ+JEndJofJMonth Indefinate N/A Archive AllJCopies Both
Start/EndJofJHold TEJ+JEndJofJMonth 3 Years Destroy AllJCopies Electronic
Start/EndJofJHold TEJ+JEndJofJYear 20 Years ReviewJByJOwner Backup Electronic
Start/EndJofJHold UponJTriggerJEvent Permanent N/A ReviewJByJOwner Primary Electronic
Start/EndJofJLitigation UponJTriggerJEvent 7 Years Destroy AllJCopies Electronic
AuditJCompletion TEJ+JEndJofJQTR 15 Years Destroy Backup Electronic
TerminationJDate TEJ+JEndJofJMonth 18 Months Archive Primary Electronic
Example'Retention'Schedule
Procedure Regulated Yes
DMPK%009 AnalyteJLC%MS Regulated No
DMPK%010 ClinicalJSampleJProcessing Regulated
DMPK%011 ExtractionJAnimalJMatrix Regulated
DMPK%012 Robot Regulated
Protocol Convenience
DMPK%013 Clinical Regulated
DMPK%014 Investigative Regulated
DMPK%015 MethodJDevelopmentJ Convenience
Report Regulated
DMPK%016 AntigenicityJJJ Regulated
DMPK%017 Metabolism Business
DMPK%018 PD Regulated
DMPK%019 PharmacokeniticJJJ Regulated
DMPK%020 PKJJ Business
DMPK%021 QAJNon%StudyJSpecificJAuditJJ Regulated
DMPK%022 StudyJSpecificJAuditJ Regulated
DMPK%023 Certificate'of'Analysis'(CoA) Regulated
SOP Business
DMPK%024 AnalyticalJValidationJMethodsJJ Business
DMPK%025 ChangeJControlJDocumentation Convenience
DMPK%026 SystemJValidationJandJDecommisionConvenience
DMPK%027 Summary Business Yes
Record'Type
Vital'
Record
Regulated No
Managed'Vocabulary'Options'/''Selection'Choices'for'the'Chart'Above.
SubmittedJDate UponJTriggerJEvent 6 Years ReviewJByJOwner AllJCopies
Start/EndJofJHold TEJ+JEndJofJMonth Indefinate N/A ReviewJByJOwner Primary Electronic
SubmittedJDate TEJ+JEndJofJQTR 7 Years Destroy All Electronic
Trigger'Event
Retention'Period'Start'
Date
Retention'
Period'Length
Retention'
Units
Disposal'Action'at'
end'of'Period
Disposal'
Scope
SubmittedJDate UponJTriggerJEvent 1 Days ReviewJbyJOwner Primary
Managed'Vocabulary'Options'/''Selection'Choices'for'the'Chart'Above.
ID Record'Type
Vital'
Record
Data
DMPK%001 Raw%Internal Regulated Yes
DMPK%002 Raw%External Convenience No
DMPK%003 Processed Regulated Yes
DMPK%004 Analyzed Regulated Yes
DMPK%005 Guidelines Regulated Yes
DMPK%006 Manual Regulated Yes
DMPK%007 Method'Development Convenience Yes
DMPK%008 Pictures Convenience Yes
Example'Retention'Schedule
Record Series Title
Example'DMPK'&'AP
Trigger'Event
Retention'Period'
Start'Date
Retention'
Period'Length
Retention'
Units
Action'at'end'of'
Period
Disposal'
Scope
Media'
Type Notes Legal'Citation
Start/EndJofJLitigation UponJTriggerJEvent 4 Months Destroy Backup Both
Start/EndJofJHold TEJ+JEndJofJMonth Indefinate N/A Archive AllJCopies Both
Start/EndJofJHold TEJ+JEndJofJMonth 3 Years Destroy AllJCopies Electronic
Start/EndJofJHold TEJ+JEndJofJYear 20 Years ReviewJByJOwner Backup Electronic
Start/EndJofJHold UponJTriggerJEvent Permanent N/A ReviewJByJOwner Primary Electronic
Start/EndJofJLitigation UponJTriggerJEvent 7 Years Destroy AllJCopies Electronic
AuditJCompletion TEJ+JEndJofJQTR 15 Years Destroy Backup Electronic
TerminationJDate TEJ+JEndJofJMonth 18 Months Archive Primary Electronic
Example'Retention'Schedule
Procedure Regulated Yes
DMPK%009 AnalyteJLC%MS Regulated No
DMPK%010 ClinicalJSampleJProcessing Regulated
DMPK%011 ExtractionJAnimalJMatrix Regulated
DMPK%012 Robot Regulated
Protocol Convenience
DMPK%013 Clinical Regulated
DMPK%014 Investigative Regulated
DMPK%015 MethodJDevelopmentJ Convenience
Report Regulated
DMPK%016 AntigenicityJJJ Regulated
DMPK%017 Metabolism Business
DMPK%018 PD Regulated
DMPK%019 PharmacokeniticJJJ Regulated
DMPK%020 PKJJ Business
DMPK%021 QAJNon%StudyJSpecificJAuditJJ Regulated
DMPK%022 StudyJSpecificJAuditJ Regulated
DMPK%023 Certificate'of'Analysis'(CoA) Regulated
SOP Business
DMPK%024 AnalyticalJValidationJMethodsJJ Business
DMPK%025 ChangeJControlJDocumentation Convenience
DMPK%026 SystemJValidationJandJDecommisionConvenience
DMPK%027 Summary Business Yes
Record'Type
Vital'
Record
Regulated No
Managed'Vocabulary'Options'/''Selection'Choices'for'the'Chart'Above.
SubmittedJDate UponJTriggerJEvent 6 Years ReviewJByJOwner AllJCopies
Start/EndJofJHold TEJ+JEndJofJMonth Indefinate N/A ReviewJByJOwner Primary Electronic
SubmittedJDate TEJ+JEndJofJQTR 7 Years Destroy All Electronic
Trigger'Event
Retention'Period'Start'
Date
Retention'
Period'Length
Retention'
Units
Disposal'Action'at'
end'of'Period
Disposal'
Scope
SubmittedJDate UponJTriggerJEvent 1 Days ReviewJbyJOwner Primary
Managed'Vocabulary'Options'/''Selection'Choices'for'the'Chart'Above.
ID Record'Type
Vital'
Record
Data
DMPK%001 Raw%Internal Regulated Yes
DMPK%002 Raw%External Convenience No
DMPK%003 Processed Regulated Yes
DMPK%004 Analyzed Regulated Yes
DMPK%005 Guidelines Regulated Yes
DMPK%006 Manual Regulated Yes
DMPK%007 Method'Development Convenience Yes
DMPK%008 Pictures Convenience Yes
Example'Retention'Schedule
Record Series Title
Example'DMPK'&'AP
Trigger'Event
Retention'Period'
Start'Date
Retention'
Period'Length
Retention'
Units
Action'at'end'of'
Period
Disposal'
Scope
Media'
Type Notes Legal'Citation
Start/EndJofJLitigation UponJTriggerJEvent 4 Months Destroy Backup Both
Start/EndJofJHold TEJ+JEndJofJMonth Indefinate N/A Archive AllJCopies Both
Start/EndJofJHold TEJ+JEndJofJMonth 3 Years Destroy AllJCopies Electronic
Start/EndJofJHold TEJ+JEndJofJYear 20 Years ReviewJByJOwner Backup Electronic
Start/EndJofJHold UponJTriggerJEvent Permanent N/A ReviewJByJOwner Primary Electronic
Start/EndJofJLitigation UponJTriggerJEvent 7 Years Destroy AllJCopies Electronic
AuditJCompletion TEJ+JEndJofJQTR 15 Years Destroy Backup Electronic
TerminationJDate TEJ+JEndJofJMonth 18 Months Archive Primary Electronic
Example'Retention'Schedule
Procedure Regulated Yes
DMPK%009 AnalyteJLC%MS Regulated No
DMPK%010 ClinicalJSampleJProcessing Regulated
DMPK%011 ExtractionJAnimalJMatrix Regulated
DMPK%012 Robot Regulated
Protocol Convenience
DMPK%013 Clinical Regulated
DMPK%014 Investigative Regulated
DMPK%015 MethodJDevelopmentJ Convenience
Report Regulated
DMPK%016 AntigenicityJJJ Regulated
DMPK%017 Metabolism Business
DMPK%018 PD Regulated
DMPK%019 PharmacokeniticJJJ Regulated
DMPK%020 PKJJ Business
DMPK%021 QAJNon%StudyJSpecificJAuditJJ Regulated
DMPK%022 StudyJSpecificJAuditJ Regulated
DMPK%023 Certificate'of'Analysis'(CoA) Regulated
SOP Business
DMPK%024 AnalyticalJValidationJMethodsJJ Business
DMPK%025 ChangeJControlJDocumentation Convenience
DMPK%026 SystemJValidationJandJDecommisionConvenience
DMPK%027 Summary Business Yes
Record'Type
Vital'
Record
Regulated No
Managed'Vocabulary'Options'/''Selection'Choices'for'the'Chart'Above.
SubmittedJDate UponJTriggerJEvent 6 Years ReviewJByJOwner AllJCopies
Start/EndJofJHold TEJ+JEndJofJMonth Indefinate N/A ReviewJByJOwner Primary Electronic
SubmittedJDate TEJ+JEndJofJQTR 7 Years Destroy All Electronic
Trigger'Event
Retention'Period'Start'
Date
Retention'
Period'Length
Retention'
Units
Disposal'Action'at'
end'of'Period
Disposal'
Scope
SubmittedJDate UponJTriggerJEvent 1 Days ReviewJbyJOwner Primary
Managed'Vocabulary'Options'/''Selection'Choices'for'the'Chart'Above.
9. ID Record'Type
Vital'
Record
Data
DMPK%001 Raw%Internal Regulated Yes
DMPK%002 Raw%External Convenience No
DMPK%003 Processed Regulated Yes
DMPK%004 Analyzed Regulated Yes
DMPK%005 Guidelines Regulated Yes
DMPK%006 Manual Regulated Yes
DMPK%007 Method'Development Convenience Yes
DMPK%008 Pictures Convenience Yes
Example'Retention'Schedule
Record Series Title
Example'DMPK'&'AP
Trigger'Event
Retention'Period'
Start'Date
Retention'
Period'Length
Retention'
Units
Action'at'end'of'
Period
Disposal'
Scope
Media'
Type Notes Legal'Citation
Start/EndJofJLitigation UponJTriggerJEvent 4 Months Destroy Backup Both
Start/EndJofJHold TEJ+JEndJofJMonth Indefinate N/A Archive AllJCopies Both
Start/EndJofJHold TEJ+JEndJofJMonth 3 Years Destroy AllJCopies Electronic
Start/EndJofJHold TEJ+JEndJofJYear 20 Years ReviewJByJOwner Backup Electronic
Start/EndJofJHold UponJTriggerJEvent Permanent N/A ReviewJByJOwner Primary Electronic
Start/EndJofJLitigation UponJTriggerJEvent 7 Years Destroy AllJCopies Electronic
AuditJCompletion TEJ+JEndJofJQTR 15 Years Destroy Backup Electronic
TerminationJDate TEJ+JEndJofJMonth 18 Months Archive Primary Electronic
Example'Retention'Schedule
Procedure Regulated Yes
DMPK%009 AnalyteJLC%MS Regulated No
DMPK%010 ClinicalJSampleJProcessing Regulated
DMPK%011 ExtractionJAnimalJMatrix Regulated
DMPK%012 Robot Regulated
Protocol Convenience
DMPK%013 Clinical Regulated
DMPK%014 Investigative Regulated
DMPK%015 MethodJDevelopmentJ Convenience
Report Regulated
DMPK%016 AntigenicityJJJ Regulated
DMPK%017 Metabolism Business
DMPK%018 PD Regulated
DMPK%019 PharmacokeniticJJJ Regulated
DMPK%020 PKJJ Business
DMPK%021 QAJNon%StudyJSpecificJAuditJJ Regulated
DMPK%022 StudyJSpecificJAuditJ Regulated
DMPK%023 Certificate'of'Analysis'(CoA) Regulated
SOP Business
DMPK%024 AnalyticalJValidationJMethodsJJ Business
DMPK%025 ChangeJControlJDocumentation Convenience
DMPK%026 SystemJValidationJandJDecommisionConvenience
DMPK%027 Summary Business Yes
Record'Type
Vital'
Record
Regulated No
Managed'Vocabulary'Options'/''Selection'Choices'for'the'Chart'Above.
SubmittedJDate UponJTriggerJEvent 6 Years ReviewJByJOwner AllJCopies
Start/EndJofJHold TEJ+JEndJofJMonth Indefinate N/A ReviewJByJOwner Primary Electronic
SubmittedJDate TEJ+JEndJofJQTR 7 Years Destroy All Electronic
Trigger'Event
Retention'Period'Start'
Date
Retention'
Period'Length
Retention'
Units
Disposal'Action'at'
end'of'Period
Disposal'
Scope
SubmittedJDate UponJTriggerJEvent 1 Days ReviewJbyJOwner Primary
Managed'Vocabulary'Options'/''Selection'Choices'for'the'Chart'Above.
ID Record'Type
Vital'
Record
Data
DMPK%001 Raw%Internal Regulated Yes
DMPK%002 Raw%External Convenience No
DMPK%003 Processed Regulated Yes
DMPK%004 Analyzed Regulated Yes
DMPK%005 Guidelines Regulated Yes
DMPK%006 Manual Regulated Yes
DMPK%007 Method'Development Convenience Yes
DMPK%008 Pictures Convenience Yes
Example'Retention'Schedule
Record Series Title
Example'DMPK'&'AP
Trigger'Event
Retention'Period'
Start'Date
Retention'
Period'Length
Retention'
Units
Action'at'end'of'
Period
Disposal'
Scope
Media'
Type Notes Legal'Citation
Start/EndJofJLitigation UponJTriggerJEvent 4 Months Destroy Backup Both
Start/EndJofJHold TEJ+JEndJofJMonth Indefinate N/A Archive AllJCopies Both
Start/EndJofJHold TEJ+JEndJofJMonth 3 Years Destroy AllJCopies Electronic
Start/EndJofJHold TEJ+JEndJofJYear 20 Years ReviewJByJOwner Backup Electronic
Start/EndJofJHold UponJTriggerJEvent Permanent N/A ReviewJByJOwner Primary Electronic
Start/EndJofJLitigation UponJTriggerJEvent 7 Years Destroy AllJCopies Electronic
AuditJCompletion TEJ+JEndJofJQTR 15 Years Destroy Backup Electronic
TerminationJDate TEJ+JEndJofJMonth 18 Months Archive Primary Electronic
Example'Retention'Schedule
Procedure Regulated Yes
DMPK%009 AnalyteJLC%MS Regulated No
DMPK%010 ClinicalJSampleJProcessing Regulated
DMPK%011 ExtractionJAnimalJMatrix Regulated
DMPK%012 Robot Regulated
Protocol Convenience
DMPK%013 Clinical Regulated
DMPK%014 Investigative Regulated
DMPK%015 MethodJDevelopmentJ Convenience
Report Regulated
DMPK%016 AntigenicityJJJ Regulated
DMPK%017 Metabolism Business
DMPK%018 PD Regulated
DMPK%019 PharmacokeniticJJJ Regulated
DMPK%020 PKJJ Business
DMPK%021 QAJNon%StudyJSpecificJAuditJJ Regulated
DMPK%022 StudyJSpecificJAuditJ Regulated
DMPK%023 Certificate'of'Analysis'(CoA) Regulated
SOP Business
DMPK%024 AnalyticalJValidationJMethodsJJ Business
DMPK%025 ChangeJControlJDocumentation Convenience
DMPK%026 SystemJValidationJandJDecommisionConvenience
DMPK%027 Summary Business Yes
Record'Type
Vital'
Record
Regulated No
Managed'Vocabulary'Options'/''Selection'Choices'for'the'Chart'Above.
SubmittedJDate UponJTriggerJEvent 6 Years ReviewJByJOwner AllJCopies
Start/EndJofJHold TEJ+JEndJofJMonth Indefinate N/A ReviewJByJOwner Primary Electronic
SubmittedJDate TEJ+JEndJofJQTR 7 Years Destroy All Electronic
Trigger'Event
Retention'Period'Start'
Date
Retention'
Period'Length
Retention'
Units
Disposal'Action'at'
end'of'Period
Disposal'
Scope
SubmittedJDate UponJTriggerJEvent 1 Days ReviewJbyJOwner Primary
Managed'Vocabulary'Options'/''Selection'Choices'for'the'Chart'Above.
ID Record'Type
Vital'
Record
Data
DMPK%001 Raw%Internal Regulated Yes
DMPK%002 Raw%External Convenience No
DMPK%003 Processed Regulated Yes
DMPK%004 Analyzed Regulated Yes
DMPK%005 Guidelines Regulated Yes
DMPK%006 Manual Regulated Yes
DMPK%007 Method'Development Convenience Yes
DMPK%008 Pictures Convenience Yes
Example'Retention'Schedule
Record Series Title
Example'DMPK'&'AP
Trigger'Event
Retention'Period'
Start'Date
Retention'
Period'Length
Retention'
Units
Action'at'end'of'
Period
Disposal'
Scope
Media'
Type Notes Legal'Citation
Start/EndJofJLitigation UponJTriggerJEvent 4 Months Destroy Backup Both
Start/EndJofJHold TEJ+JEndJofJMonth Indefinate N/A Archive AllJCopies Both
Start/EndJofJHold TEJ+JEndJofJMonth 3 Years Destroy AllJCopies Electronic
Start/EndJofJHold TEJ+JEndJofJYear 20 Years ReviewJByJOwner Backup Electronic
Start/EndJofJHold UponJTriggerJEvent Permanent N/A ReviewJByJOwner Primary Electronic
Start/EndJofJLitigation UponJTriggerJEvent 7 Years Destroy AllJCopies Electronic
AuditJCompletion TEJ+JEndJofJQTR 15 Years Destroy Backup Electronic
TerminationJDate TEJ+JEndJofJMonth 18 Months Archive Primary Electronic
Example'Retention'Schedule
Procedure Regulated Yes
DMPK%009 AnalyteJLC%MS Regulated No
DMPK%010 ClinicalJSampleJProcessing Regulated
DMPK%011 ExtractionJAnimalJMatrix Regulated
DMPK%012 Robot Regulated
Protocol Convenience
DMPK%013 Clinical Regulated
DMPK%014 Investigative Regulated
DMPK%015 MethodJDevelopmentJ Convenience
Report Regulated
DMPK%016 AntigenicityJJJ Regulated
DMPK%017 Metabolism Business
DMPK%018 PD Regulated
DMPK%019 PharmacokeniticJJJ Regulated
DMPK%020 PKJJ Business
DMPK%021 QAJNon%StudyJSpecificJAuditJJ Regulated
DMPK%022 StudyJSpecificJAuditJ Regulated
DMPK%023 Certificate'of'Analysis'(CoA) Regulated
SOP Business
DMPK%024 AnalyticalJValidationJMethodsJJ Business
DMPK%025 ChangeJControlJDocumentation Convenience
DMPK%026 SystemJValidationJandJDecommisionConvenience
DMPK%027 Summary Business Yes
Record'Type
Vital'
Record
Regulated No
Managed'Vocabulary'Options'/''Selection'Choices'for'the'Chart'Above.
SubmittedJDate UponJTriggerJEvent 6 Years ReviewJByJOwner AllJCopies
Start/EndJofJHold TEJ+JEndJofJMonth Indefinate N/A ReviewJByJOwner Primary Electronic
SubmittedJDate TEJ+JEndJofJQTR 7 Years Destroy All Electronic
Trigger'Event
Retention'Period'Start'
Date
Retention'
Period'Length
Retention'
Units
Disposal'Action'at'
end'of'Period
Disposal'
Scope
SubmittedJDate UponJTriggerJEvent 1 Days ReviewJbyJOwner Primary
Managed'Vocabulary'Options'/''Selection'Choices'for'the'Chart'Above.
ID Record'Type
Vital'
Record
Data
DMPK%001 Raw%Internal Regulated Yes
DMPK%002 Raw%External Convenience No
DMPK%003 Processed Regulated Yes
DMPK%004 Analyzed Regulated Yes
DMPK%005 Guidelines Regulated Yes
DMPK%006 Manual Regulated Yes
DMPK%007 Method'Development Convenience Yes
DMPK%008 Pictures Convenience Yes
Example'Retention'Schedule
Record Series Title
Example'DMPK'&'AP
Trigger'Event
Retention'Period'
Start'Date
Retention'
Period'Length
Retention'
Units
Action'at'end'of'
Period
Disposal'
Scope
Media'
Type Notes Legal'Citation
Start/EndJofJLitigation UponJTriggerJEvent 4 Months Destroy Backup Both
Start/EndJofJHold TEJ+JEndJofJMonth Indefinate N/A Archive AllJCopies Both
Start/EndJofJHold TEJ+JEndJofJMonth 3 Years Destroy AllJCopies Electronic
Start/EndJofJHold TEJ+JEndJofJYear 20 Years ReviewJByJOwner Backup Electronic
Start/EndJofJHold UponJTriggerJEvent Permanent N/A ReviewJByJOwner Primary Electronic
Start/EndJofJLitigation UponJTriggerJEvent 7 Years Destroy AllJCopies Electronic
AuditJCompletion TEJ+JEndJofJQTR 15 Years Destroy Backup Electronic
TerminationJDate TEJ+JEndJofJMonth 18 Months Archive Primary Electronic
Example'Retention'Schedule
Procedure Regulated Yes
DMPK%009 AnalyteJLC%MS Regulated No
DMPK%010 ClinicalJSampleJProcessing Regulated
DMPK%011 ExtractionJAnimalJMatrix Regulated
DMPK%012 Robot Regulated
Protocol Convenience
DMPK%013 Clinical Regulated
DMPK%014 Investigative Regulated
DMPK%015 MethodJDevelopmentJ Convenience
Report Regulated
DMPK%016 AntigenicityJJJ Regulated
DMPK%017 Metabolism Business
DMPK%018 PD Regulated
DMPK%019 PharmacokeniticJJJ Regulated
DMPK%020 PKJJ Business
DMPK%021 QAJNon%StudyJSpecificJAuditJJ Regulated
DMPK%022 StudyJSpecificJAuditJ Regulated
DMPK%023 Certificate'of'Analysis'(CoA) Regulated
SOP Business
DMPK%024 AnalyticalJValidationJMethodsJJ Business
DMPK%025 ChangeJControlJDocumentation Convenience
DMPK%026 SystemJValidationJandJDecommisionConvenience
DMPK%027 Summary Business Yes
Record'Type
Vital'
Record
Regulated No
Managed'Vocabulary'Options'/''Selection'Choices'for'the'Chart'Above.
SubmittedJDate UponJTriggerJEvent 6 Years ReviewJByJOwner AllJCopies
Start/EndJofJHold TEJ+JEndJofJMonth Indefinate N/A ReviewJByJOwner Primary Electronic
SubmittedJDate TEJ+JEndJofJQTR 7 Years Destroy All Electronic
Trigger'Event
Retention'Period'Start'
Date
Retention'
Period'Length
Retention'
Units
Disposal'Action'at'
end'of'Period
Disposal'
Scope
SubmittedJDate UponJTriggerJEvent 1 Days ReviewJbyJOwner Primary
Managed'Vocabulary'Options'/''Selection'Choices'for'the'Chart'Above.
ID Record'Type
Vital'
Record
Data
DMPK%001 Raw%Internal Regulated Yes
DMPK%002 Raw%External Convenience No
DMPK%003 Processed Regulated Yes
DMPK%004 Analyzed Regulated Yes
DMPK%005 Guidelines Regulated Yes
DMPK%006 Manual Regulated Yes
DMPK%007 Method'Development Convenience Yes
DMPK%008 Pictures Convenience Yes
Example'Retention'Schedule
Record Series Title
Example'DMPK'&'AP
Trigger'Event
Retention'Period'
Start'Date
Retention'
Period'Length
Retention'
Units
Action'at'end'of'
Period
Disposal'
Scope
Media'
Type Notes Legal'Citation
Start/EndJofJLitigation UponJTriggerJEvent 4 Months Destroy Backup Both
Start/EndJofJHold TEJ+JEndJofJMonth Indefinate N/A Archive AllJCopies Both
Start/EndJofJHold TEJ+JEndJofJMonth 3 Years Destroy AllJCopies Electronic
Start/EndJofJHold TEJ+JEndJofJYear 20 Years ReviewJByJOwner Backup Electronic
Start/EndJofJHold UponJTriggerJEvent Permanent N/A ReviewJByJOwner Primary Electronic
Start/EndJofJLitigation UponJTriggerJEvent 7 Years Destroy AllJCopies Electronic
AuditJCompletion TEJ+JEndJofJQTR 15 Years Destroy Backup Electronic
TerminationJDate TEJ+JEndJofJMonth 18 Months Archive Primary Electronic
Example'Retention'Schedule
Procedure Regulated Yes
DMPK%009 AnalyteJLC%MS Regulated No
DMPK%010 ClinicalJSampleJProcessing Regulated
DMPK%011 ExtractionJAnimalJMatrix Regulated
DMPK%012 Robot Regulated
Protocol Convenience
DMPK%013 Clinical Regulated
DMPK%014 Investigative Regulated
DMPK%015 MethodJDevelopmentJ Convenience
Report Regulated
DMPK%016 AntigenicityJJJ Regulated
DMPK%017 Metabolism Business
DMPK%018 PD Regulated
DMPK%019 PharmacokeniticJJJ Regulated
DMPK%020 PKJJ Business
DMPK%021 QAJNon%StudyJSpecificJAuditJJ Regulated
DMPK%022 StudyJSpecificJAuditJ Regulated
DMPK%023 Certificate'of'Analysis'(CoA) Regulated
SOP Business
DMPK%024 AnalyticalJValidationJMethodsJJ Business
DMPK%025 ChangeJControlJDocumentation Convenience
DMPK%026 SystemJValidationJandJDecommisionConvenience
DMPK%027 Summary Business Yes
Record'Type
Vital'
Record
Regulated No
Managed'Vocabulary'Options'/''Selection'Choices'for'the'Chart'Above.
SubmittedJDate UponJTriggerJEvent 6 Years ReviewJByJOwner AllJCopies
Start/EndJofJHold TEJ+JEndJofJMonth Indefinate N/A ReviewJByJOwner Primary Electronic
SubmittedJDate TEJ+JEndJofJQTR 7 Years Destroy All Electronic
Trigger'Event
Retention'Period'Start'
Date
Retention'
Period'Length
Retention'
Units
Disposal'Action'at'
end'of'Period
Disposal'
Scope
SubmittedJDate UponJTriggerJEvent 1 Days ReviewJbyJOwner Primary
Managed'Vocabulary'Options'/''Selection'Choices'for'the'Chart'Above.
4. The Heart of RM: The RM Policy and Retentions Schedule, cont.
Considerations for creating the RM Policy and Retentions Schedule:
To do RM, You will need to do a Content Assessment and Build a
Taxonomy with Metadata … the extent and granularity is TBD
o Sorry, there is no way around it. Your RM policy, schedule and system are
based on these design documents. Start with something good and tailor it.
o Don’t start at the beginning. If done properly, this effort can be integrated
with an ECMS project to save significant budget.
o DON’T DO IT TWICE! It’s expensive and time consuming.
Acknowledge All Content/Record Types…even if they are not addressed
initially by your RM effort
o Areas such as digital voicemails, phone SMS/texts, paper and so on are
records. These may be more difficult to address in the short term. However,
put them into your RM roadmap nonetheless and prioritize accordingly for
the future.
o Phase it.
“If your company has an operational RM Policy, you are in control of your own content and its
accessibility during the eDiscovery process. If your company doesn’t have RM in place, the
opposing council now controls your company’s content and you.”
10. 5. An Opportunity Lies in Alignment of RM and ECMS Efforts
Finding the ‘natural’ alignment of the drivers’ components
can improve the RM business case and greatly reduce costs.
Two natural alignments that can work well:
Implementation of an ECMS and Reduction of Storage costs:
o More department-focused, vertical
o Addressing broader, larger sets of content types across
more groups
o Driven by efficiency needs and ‘big bucket’ opportunities
o Precision and control are less critical (but still important…)
Improving Litigation Performance, Compliance Adherence and
Business Continuity Risk Management
o Business process and scientific process focused, horizontal
o Addressing fewer, more controlled, more vital content
types/records across fewer groups
o Driven by effectiveness and strategic company needs
o Precision and control are more critical
11. 6. RM in The Cloud. Mild to Moderate Turbulence Ahead
Cloud-based document and content storage can offer significant functional and
cost advantages. However, there are some points to consider.
In a recent poll of 633 different companies’ IT leadership about whether they would
consider a Cloud solution for RM:
o ~ 60% said ‘No, Definitely Not’ or ‘No, Probably Not’
o And yet…how many personnel use Box, DropBox, Google Docs…?
Cloud Considerations:
o eDiscovery and hold actions apply to content in the cloud, as well.
It’s one more place that can be discovered.
Chain of custody is difficult to maintain. (e.g. Lack of standard system metadata)
o Cloud CMS and RM functional capabilities are limited.
Arguably, the most advanced vendor is Box.Net/.Com. However, even their CMS and RM
capabilities fall short of the most basic CMS’s in the market. Potential issues include:
Holding the same content/documents across multiple, simultaneous legal matters
Providing detailed auditing of authoring and editing to the record and content types
Dynamic manipulation of records related metadata based on user activities
Access and control granularity of the content type
Vendors are aware and attempting to address deficiencies. But be wary of the marketing.
.
12. 6. RM in The Cloud. Mild to Moderate Turbulence Ahead, cont.
Cloud Considerations, continued:
o Other points to think about:
Who really owns your content in the cloud? Where is it stored?
How are backups tested?
How do you walk away from the vendor and transfer content
back internally?
How does the vendor respond to your discovery support
request, timeframes, etc?
o In summary, cloud vendors offer:
An inexpensive and convenient alternative to internal file
storage.
A great way to distribute materials to mobile workers and keep
them in sync.
An easy way to backup remote workers’ content.
A limited set of CMS capabilities and even more limited RM
capabilities.
Consider using the Cloud vendors to store and distribute content that
would not be considered a business or legal record or content that is
also well controlled internally.
13. 7. The RM Project. A Few Final Thoughts
Leverage other Content Projects’ Budgets and Benefits
o The deliverables for RM are very, very similar (not exactly the same, however) for ECMS,
Knowledge Management, Information Governance, Retiring Workforce efforts, etc.
o Combining projects appropriately can save 30 - 40%+ off the total costs (TCO) than if
projects were done individually.
o The combined benefits of these other projects AND RM may tip leadership into the ‘Get it
done’ camp.
RM is not just an IT Project
o RM is pervasive; building and using the RM capability is intrusive. The organization will
change how it operates with respect to content and information. Many of these changes
may be unwelcomed by individuals, albeit positive for the organization as a whole.
o IT should partner with Legal, department leaders and other key influencers to make this
work. Goals, objectives, priorities and dedicated effort must be aligned across these
partners to make RM work.
o Organization change management will be required and be a key part of any RM program’s
success.
o RM is a content and document focused project. Appropriately skilled resources are needed.
14. 8. Helpful Resources
Association of Information and Imaging Management (www.aiim.org)
Association of Records Managers and Administrators (www.arma.org)
Electronic Discovery Reference Model (www.edrm.net)
ISO 15489 Part 1
Victorian Electronic Records Strategy (AU)
DoD 5015.2 STD v3 (US)
MoReq2010 v1.1 (EU)
Book: Records Management for Dummies (Surprisingly, not bad…)
Managing Electronic Records Conference - Chicago – May 2013
Documentum/EMC, Symantec and Opentext have quite a bit of good content on their
websites