©2013 Waters Corporation 1

Trends and solutions for archiving in pharmaceutical industry.

Didier Coyman / Ömer Yilmaz

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Why?

Regulatory requirements

Storage capacity

Legal

Company Ethic

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Regulatory Requirements

Copies of Electronic Records for Inspection – Accessibility for Inspection

– Integrity of Content and Meaning

– Human Readable Form

– Standard Portable Formats

Retention and Maintenance of Records – GxP demands Archival of Records for Extended Time

– Requirement to keep the Raw Data

– Ability to Reprocess

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Record Retention Requirements

Industry Segment, Regulator and Type of Record

Typical Retention Period

Pharma: Good Laboratory Practices; records related to a new drug application (NDAs)

Date of submission plus 5 years

Health Care: medical records Life of patient plus “n” years

Drug/device study records Marketing application plus 2-3 years

Government records 20-50 years, or permanent

Copyright records (all organizations) Life of copyright = 95 years or as business needs dictate

Patent records and supporting data Application plus 17 years

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Legal Hold

Will prevent:

– Changes to the record

– Changes to the metadata

– Deletion

– Data Retention Management

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Lifespans

Software lifetime: approx. 9 years*

Hardware depreciation: 3-5 years

Comparison of reliability over three years

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, Confe

rence

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gs

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Strategy

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Digital Archiving Checklist/Aspects

What should be considered for data archival projects?

Define records retention policy

Include archiving, retrieval, and disposal in the data life cycle

Choose the file format for archival material

Implement redundancy to ensure data survival

Choose the storage medium and test the migration method to ensure accuracy of the copies.

For short periods of retention, storing hardware and software can be a smart strategy. In parallel, monitor software backward compatibility to determine when the time comes for migration.

Test record retrieval

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Common Strategies

Keep old hardware – Hardware failures

– Lack of spare parts/maintenance

– Lack of knowledge

Virtualize old software – Lack of knowledge

– No updates

Convert data – Either updated proprietary formats/databases

– Or platform independent standards

– Original raw data must still be retained!

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Current Analytical Data Standards

JCAMP 1988

today

Andi/AIA

1992/93 2001

AnIML

2013/14

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AnIML is…

… XML-based – Human readable

– Long term stable

– Non-proprietary

– Easy to index via metadata

… Technique-agnostic – One format fits many

– Easily shareable

– Viewable with a generic viewer without the original application!

… Easy to re-use and integrate

… Compliant-ready

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Why AnIML?

AnIML Data Set

Workflow Information

Metadata

Instrument Data

Processed Data

Result Data

Audit Trail, Signatures

Sampling

Instrument Data

Processed Data

Result Data

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Migrate to new standards

JCAMP ANDI AnIML

JCAMP ANDI

+ + /

today tomorrow

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Standards for Report documents

EMF - fully scalable and re-usable

PDF - usually device-independent

EMF and PDF – more compact, often with a better quality – Metadata can be embedded

PDF/A (ISO-19005-1, 2005)

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PDF/A

ISO standard

100% self-contained

Based on Adobe PDF Reference 1.7

Specific features either mandatory, recommended, restricted, or prohibited

Several parts: – Part-1 (PDF/A-1) approved September 28, 2005

– Part-2 (PDF/A-2) approved June 20, 2011

o PDF/A-1 remains in effect

o PDF/A-1-conformant files also conform to PDF/A-2

– Part-3 (PDF/A-3) approved October 18, 2012

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Long Term Archive Repository (DB + Managed Store)

Keep data secure

Observe retention periods – Protect against premature deletion

Make available on request

Repository vs. Archive Long Term Archiving

Data collection

Print & file data

Metadata extraction

Share data in community

Simple retrieval

Data re-use

Header Data

Analytical Data,

Binaries

LT Archive Repository Database

Archive

Record Data

Restore

Search

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Possible solution

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Data Management – Closing the Data Lifecycle

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Record retention

NuGenesis 8 will help you in the implementation of your – Retention policies

– Retention period

– Delete method

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Legal Hold

Will prevent:

– Changes to the record

– Changes to the metadata

– Deletion

– Data Retention Management

Allowed:

– OSM

– Data Management

Privilege controlled

Multiple legal holds possible

Across Projects

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Long Term Archive - Storage Gateway

One interface to multiple storage solutions – Tested and supported for SDMS: EMC² Centera

Database

OSM

Storage Gateway

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