Regulatory Compliance and Long-Term Storage of Data

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

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►Over

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►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

[email protected]

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