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Document Management In Pharma
- 1. Electronic Internal Paper Interface! Sources Electronic External Paper IND CTA Regulatory Applications Forms MAA Variations Standard Operating Procedures (SOP) Certificate of Analysis (CoA) Stability Reports Stability Data Sets Clinical Study Protocols Non Clinical Clinical Study Reports Non Clinical Clinical Data Listing Non Clinical Regulated SAS Data Sets Clinical Non Clinical Study Summaries Clinical Doc Investigator Brochures (IB) Type Core Data Sheets (CDS) Adverse Event Forms (AE) Patient Safety Update Reports (PSUR) Annual Safety Reports Pertinent Finance Documents Subtopic Document Owner Patient Information Leaflet (PIL) (Controls & Manages eMail Document Life Cycle) Authors Letters Training Records Primary Secondary References Papers Reviewers Promotional Material Non Regulated Approvers Actors Publications Viewers eMail Archivist Product Code Submission Collator Project Code Meta Data Business Unit Administrator Templates Trial Code IT System Administrator Protocol Subtopic Trial Master File Module 1 Module 2 eCTD Module 3 CTD Document Aggregation Dossiers Module 4 Module 5 Subtopic Office Tools Electronic Word Processed Creation Paper Spreadsheet Manual Presentations Processes Office Tools Project Plans Electronic Created Review PDF Paper Manual Other Content Creators Subtopic Inputs Wet Approval eMail Work in Progress Password/User ID Interface Biometric Signatures CFR 21 Part 11 Digital Certificates (SAFE) Approve TIFF Electronic Workflow & Life Cycle Scanned PDF Watermarks Expiry Viewer R Version Management Revisions & Updates Document Create/Read/Update/Approve/Delete (Unit/Global) V1.4 PDF Management In Author XML Pharma Formats Publisher CRAD (Unit/Global) V 1.4 Publish (© Anil Dhiri, 2006 ) PDF/A Role Based Users Approvers RA Version Management Reviewer RA Electronic Signature 21 CFR Part 11 CRAD Electronic Record Administrator HL 7 and RPS Technical eCTD ICH Regulations Sarbanes Oxley Management/Legal Basle 2 Print Online PDF/A PDF HTML/XML Outputs Audit Trail History Folder Index Internally Contract Research Organisation Interface Encryption FDA Gateway Transmission & Exchange Provenance Externally MHRA Gateway Regulators Access Security Other Gateways Administrator Control Recycle Bin Partners Safe Delete Microfiche Paper Who When CD/Optical Audit Trails Where/What Nearline Archive How Offline Electronic PDF Formats Retention & Storage Web Access I.E. 6 or above XML Up to 30 years Postgres Regulated Open Source MySQL Duration & Policy Databases Up to 5 to 7 years Non Regulated Oracle SQL Templates Configurable Business Rules Application Layer Stack Style Sheets Configurable Work Flow XML TWAIN Interface Scanning Layer Stack CTD Standards eCTD Dossier Compilation Stack eCTD EDI EVMPD Technology Shared Drives Network Drives Flat Files USB Sticks Flash Cards Metadata Search Full Test Retrieval Full Text Index Hypertext (SGML) linking Electronic Document Interchange ETRI Document Management In Pharma.mmap - 31/12/2008 -