Trends and solutions for archiving in pharmaceutical industry. Didier Coyman / Ömer Yilmaz
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1 Trends and solutions for archiving in pharmaceutical industry. Didier Coyman / Ömer Yilmaz 2013 Waters Corporation 1
2 Why? Regulatory requirements Storage capacity Legal Company Ethic 2013 Waters Corporation 2
3 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 2013 Waters Corporation 3
4 Record Retention Requirements Industry Segment, Regulator and Type of Record Pharma: Good Laboratory Practices; records related to a new drug application (NDAs) Health Care: medical records Typical Retention Period Date of submission plus 5 years Life of patient plus n years Drug/device study records Marketing application plus 2-3 years Government records Copyright records (all organizations) Patent records and supporting data years, or permanent Life of copyright = 95 years or as business needs dictate Application plus 17 years 2013 Waters Corporation 4
5 Legal Hold Will prevent: Changes to the record Changes to the metadata Deletion Data Retention Management 2013 Waters Corporation 5
6 Lifespans Software lifetime: approx. 9 years* Hardware depreciation: 3-5 years Comparison of reliability over three years *Software lifetime and its evolution process over generations, Tamai, T., Torimitsu, Y., Conference on Software Maintenance, 1992, Proceedings 2013 Waters Corporation 6
7 Strategy 2013 Waters Corporation 7
8 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 2013 Waters Corporation 8
9 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! 2013 Waters Corporation 9
10 Current Analytical Data Standards 1988 JCAMP today Andi/AIA 1992/ /14 AnIML 2013 Waters Corporation 10
11 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 2013 Waters Corporation 11
12 Why AnIML? AnIML Data Set Workflow Information Sampling Metadata Instrument Data Instrument Data Processed Data Processed Data Result Data Audit Trail, Signatures Result Data 2013 Waters Corporation 12
13 Migrate to new standards today JCAMP tomorrow ANDI JCAMP ANDI AnIML / Waters Corporation 13
14 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 , 2005) 2013 Waters Corporation 14
15 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, Waters Corporation 15
16 Repository vs. Archive Long Term Archiving Repository (DB + Managed Store) Data collection Print & file data Metadata extraction Share data in community Simple retrieval Data re-use Long Term Archive Keep data secure Observe retention periods Protect against premature deletion Make available on request Search Header Data Archive Analytical Data, Binaries Record Data Restore Repository Database LT Archive 2013 Waters Corporation 16
17 Possible solution 2013 Waters Corporation 17
18 Data Management Closing the Data Lifecycle 2013 Waters Corporation 18
19 Record retention NuGenesis 8 will help you in the implementation of your Retention policies Retention period Delete method 2013 Waters Corporation 19
20 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 2013 Waters Corporation 20
21 Long Term Archive - Storage Gateway One interface to multiple storage solutions Tested and supported for SDMS: EMC² Centera Database OSM Storage Gateway 2013 Waters Corporation 21
22 2013 Waters Corporation 22
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