regulatory compliance and long-term storage of data
DESCRIPTION
How do you or your company tackle the long-term storage of data? Do you actively archive? In this topical webinar, Arkivum and S3 will look at the benefits and approaches to archiving electronic documents and records in the Life Sciences industry, including the challenges of regulatory requirements, how to comply with them, and how outsourcing long-term storage can form part of the solution.TRANSCRIPT
REGULATORY COMPLIANCE AND LONG-TERM STORAGE OF DATA
Dr Matthew Addis
Arkivum Ltd
WEBINAR
S3 INTRODUCTION
Mark Treweeke
Solid State Solutions Ltd. (S3)
Trusted Advisor of Choice
►Solid State Solutions (S3)› Leading independent storage integrator
› Big data and virtualisation
› Consultative approach
› Flexible range of services
►Celebrating 25 Years› Solutions not products
› Focused and Skilled
› Support
› Enduring relationships
Trusted Advisor of Choice
►Cloud Services› Archive and preservation
› Backup and DR
►Managed Services› Offload day-day management tasks
› Predictable and controlled costs
►T3 Data Centre Space› Two locations
› Very secure and very efficient
Trusted Advisor of Choice
►Over
Trusted Advisor of Choice
►Partners
Contents
• Review of requirements
• Challenges of data retention and access
• Approach and solutions
• How Arkivum can help
“Security is of key importance to our business, Arkivum’s A-Stor Pharma
service allows us to store our encrypted data for the long term in a cost
efficient way that is entirely scalable and reduces pressure on our internal
IT infrastructure.”
Dan Watkins, Oxford Fertility Clinic
REVIEW OF REQUIREMENTS
Why keep digital data
• Regulation and compliance
• Intellectual Property
• Reuse
• Save money
• Better use of in-house resources
Regulatory Compliance
• Financial, HR, Communications, Health…
• Data Protection Act
• Freedom of Information
• Statutory legislation
• Regulatory bodies
• Recommendations and good practice
Medical records
DPA, FOI, Public Records Act, BS10008
and BIP0008, IG Toolkit, Retention
Periods (Part 2), Audit Trails (Annex D3)
GxP Regulations and Guidelines
• FDA 21 CFR Part 11
• EudraLex Volume 4 Annex 11
• OECD series on GLP
• MHRA GCP guide
Research
The IT challenge
0
1
2
3
4
5
1 2 3 4 5
data volumestorage unit costIT budget
The RDM challenge
Open Access, e.g. CC0
Legacy data
Commercial research
Personal data
Third-party data
Under development
No public repository
Low cost
• Way to cope with data growth
• Free up expensive resources
• Eliminate the ‘cost of loss’
High safety• Data reuse or regulatory compliance
• Data is immutable, replicated, managed
• Auditable integrity, authenticity, access
Easy access
• Quick to retrieve data when its needed
• Frequency: each year, not each second
• Speed: minutes, not milliseconds
Common requirements
Common outcomes
• Integrity and authenticity
• Confidentiality
• Usability / ready access / readability
• Responsibility
• Risk management and proportionality
WHAT ARE THE
CHALLENGES?
20 years of keeping content alive
Digital Preservation
“Digital information lasts forever -
or five years, whichever comes first."Jeff Rothenberg
Perpetual change
• Change costs money
• Change takes time
• Change introduces risk
• Change requires validation
• Change needs planning
• Change needs management
2,200 years
30,000 years
1,200 years
20 years
200 yearsEach new generation of technology:
1000x times denser
lasts 1/10th as long
IT storage is not safe
People cause data loss too
Active Archiving
• Preservation best practice (diversity, intervention)
– Multiple copies in different locations
– Different technologies and different people
– Active management: migration, integrity
Ingest Queue
Access Queue
Replication and Repair Queue
Storage System 1 Storage System 2
Scrubbing and migration
Scrubbing and migration
Ingredients
• Skilled and trained people
• Validated processes and procedures
• Comprehensive risk management
• Specialist infrastructure
• Economies of scale
• Independent audit and validation
HOW ARKIVUM CAN HELP
Arkivum service in a nutshell
SLA with 100%
data integrity
guaranteed
World-wide
professional
indemnity
insurance
Long term
contracts for
enterprise data
archiving
Fully automated
and managed
solution
Audited and
certified to
ISO27001
Arkivum’s Active Archive
A-StorDC
A-StorDC
Encrypted
VPN
A-Stor creates an encrypted
copy on the gateway and
copies to Arkivum’s
Data Centre One
A-Stor
A-StorDC creates the
second copy in Arkivum’sData Centre Two
A-StorDC creates the
escrow copy in the
Tape Vault
Once all three copies are
confirmed safe and secure
the original copy can
safely be deleted
Trust but verify!
Audit trails
• Essential in compliance applications
• Part of records management
• Digital preservation is an active process
• Good practice to record checks/interventions
Ready made exit plan
• Metadata and data on a file system
• Open standards and formats
• 3-way agreement on ownership/access
• Drive down costs and risks
LTFS
Purchasing Options
• Pre-agreed terms
• PAYG or Paid-Up for 5,10 or 25 years
• JANET connected
• Ingress or egress included
• Migrations and refreshes included
• Audits and certification included
• Escrow copy included
• DMP friendly
• Not just for research data
• Easy budgeting
Example customers
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0870 7776111
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