Regulatory Compliance and Long-Term Storage of Data

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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.

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Regulatory Compliance and Long-Term Storage of Data

  1. 1. REGULATORY COMPLIANCE AND LONG-TERM STORAGE OF DATA Dr Matthew Addis Arkivum Ltd WEBINAR
  2. 2. S3 INTRODUCTION Mark Treweeke Solid State Solutions Ltd. (S3)
  3. 3. 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
  4. 4. 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
  5. 5. Trusted Advisor of Choice ►Over
  6. 6. Trusted Advisor of Choice ►Partners
  7. 7. 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
  8. 8. REVIEW OF REQUIREMENTS
  9. 9. Why keep digital data • Regulation and compliance • Intellectual Property • Reuse • Save money • Better use of in-house resources
  10. 10. Regulatory Compliance • Financial, HR, Communications, Health… • Data Protection Act • Freedom of Information • Statutory legislation • Regulatory bodies • Recommendations and good practice
  11. 11. Medical records DPA, FOI, Public Records Act, BS10008 and BIP0008, IG Toolkit, Retention Periods (Part 2), Audit Trails (Annex D3)
  12. 12. GxP Regulations and Guidelines • FDA 21 CFR Part 11 • EudraLex Volume 4 Annex 11 • OECD series on GLP • MHRA GCP guide
  13. 13. Research
  14. 14. The IT challenge 0 1 2 3 4 5 1 2 3 4 5 data volume storage unit cost IT budget
  15. 15. The RDM challenge Open Access, e.g. CC0 Legacy data Commercial research Personal data Third-party data Under development No public repository
  16. 16. 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
  17. 17. Common outcomes • Integrity and authenticity • Confidentiality • Usability / ready access / readability • Responsibility • Risk management and proportionality
  18. 18. WHAT ARE THE CHALLENGES?
  19. 19. 20 years of keeping content alive
  20. 20. Digital Preservation “Digital information lasts forever - or five years, whichever comes first." Jeff Rothenberg
  21. 21. Perpetual change • Change costs money • Change takes time • Change introduces risk • Change requires validation • Change needs planning • Change needs management
  22. 22. 2,200 years 30,000 years 1,200 years 20 years 200 years Each new generation of technology: 1000x times denser lasts 1/10th as long
  23. 23. IT storage is not safe
  24. 24. People cause data loss too
  25. 25. 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
  26. 26. Ingredients • Skilled and trained people • Validated processes and procedures • Comprehensive risk management • Specialist infrastructure • Economies of scale • Independent audit and validation
  27. 27. HOW ARKIVUM CAN HELP
  28. 28. 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
  29. 29. 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’s Data 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
  30. 30. Trust but verify!
  31. 31. Audit trails • Essential in compliance applications • Part of records management • Digital preservation is an active process • Good practice to record checks/interventions
  32. 32. 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
  33. 33. 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
  34. 34. Example customers
  35. 35. Trusted Advisor of Choice 1 Prisma Park, Berrington Avenue Basingstoke, Hampshire, RG24 8GT 0870 7776111 Inforeq@s3.co.ukwww.s3.co.uk We are here to help

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