Quality System
As the A-consult Quality System evolves, instructions (and related forms, where relevant) will be uploaded to our Intranet. This way everyone has access to the current descriptions of our way to work. It is from this page, the instructions are read, and forms are copied or printed to use.
The instructions, forms and templates below are all final and in current versions.
- NOTE - Due to problems with restriction to our SOP's, the links have been removed from the Intranet. The list however is still valid.
Please find the SOPs here:
I:\Quality system\03-Instructions_CURRENT
Templates:
Instructions:
QI01
Instruction for instructions (v 6.0)
QI01AP01: Document Approval Form (v. 2.0)
QI01AP02: Read and Understood Form (v. 2.0)
QI02
Definitions and Abbreviations (v. 3.0)
QI03
A-consult IT: Employees at A-consult (v. 2.0)
QI04
Submission Team (v. 02)
QI05
Archiving at A-consult a/s (v. 4.0)
QI05AP01: Structure of the Common drives (form) (v. 03)
QI05AP02: Term List for physical and electronic archiving (form) (v. 03)
QI06
Translation and proof-reading team (OK-Team) (v. 3.0)
QI06AP01: Reception procedure for OK-team tasks (v. 1.0)
QI06AP02: Specific guidance for preparation and translation of product information into Danish (v. 1.0)
QI06AP03: Check list for preparation, translation and review of product information (v. 1.0)
QI06AP04: Step-by-step guide to proof-reading (form) (v. 1.0)
QI06AP05: Critical check list for printed components (artwork) (form) (v. 1.0)
QI07
Preparation of Aggregate Reports (v. 4.0)
QI07AP01: PSUR Template (v. 2.0)
QI07AP02: DSUR template (v. 2.0)
QI07AP03: PSUR Data Package (v. 2.0)
QI07AP04: DSUR Data Package (v. 2.0)
QI07AP05: Check list for rebort compilation (v. 2.0)
QI08
Instruction for marketing material (v. 01)
QI09
Inspections and Audits at A-consult (v. 7.0)
QI09AP01: Internal audit plan and log (form) (v. 6.0)
AI09AP02: Audit Report (form) (v. 6.0)
QI09AP03: Audit Follow-up plan (form) (v. 7.0)
QI10
Education / Organisation / Jobdescriptions (v. 4.0)
QI10AP01: Pesonal Training Record (v. 4.0)
QI10AP02: Job description (v. 4.0)
QI10AP03: Curriculum Vitae (v. 4.0)
QI11
A-consult IT: Backup of A-consult data (v. 2.0)
QI12
A-consult IT: Restoration of A-consult data (v. 2.0)
QI13
eSubmissions at A-consult (v. 2.0)
QI13AP01: eCTD submission at A-consult (v. 1.0)
QI13AP02: NeeS submission at A-consult (v. 1.0)
QI13AP03: Useful links concerning legislation, guidelines etc. supporting eSubmision (v. 1.0)
QI14
Introduction programme for new employees (v. 4.0)
QI14AP01: Example of an introduction programme (v. 3.0)
QI15
EVWEB Case Handling Process (v. 5.0)
QI15AP01: Case Recieved (form) (v. 4.0) - Please right-click and chose "Save as"
QI15AP02: Case Reported (form) (v. 4.0) - Please right-click and chose "Save as"
QI15AP03: Fax expedited report (v. 4.0)
QI15AP04: AE Front Page (v. 4.0)
QI16
EVWEB Surveillance (v. 6.0)
Appendix 1: Client list (v. 6.0)
Appendix 2: EVWEB log (form) (v. 5.0)
QI17
EVWEB Data Entry (v. 3.0)
QI18
Case Narrative Writing (v. 2.0)
QI19
Expedited Reporting in case of system failure (v. 5.0)
Appendix :1 Form: CIOMS I
Appendix 2: e-transmission of ICSRs to the EMA: Steps to follow in case of system failure
Appendix 3 Form 1: NFT
Appendix 3 Form 2: TPM
Appendix 3 Form 3: NFG
Appendix 3 Form 5: NCF
Appendix 3 Form 6: NDR
Appendix 3 Form 8: TFR
QI20
Follow-up on Adverse Events (v. 3.0)
QI20AP01: Adverse Event Form (form) (v. 3.0)
QI20AP02: Patient Consent Form (form) (v. 3.0)
QI20AP03: Initial Pregnancy Questionnaire (form) (v. 3.0)
QI20AP04: Pregnancy Outcome Questionnaire (form) (v. 3.0)
QI20AP05: Follow-up request on Adverse Event Report (form) (v. 3.0)
QI20AP06: Follow-up reminding letters (form) (v. 3.0)
QI20AP07: Adverse Event Form (Clinical studies) (form) (v. 3.0)
QI20AP08: Case Follow-up Log (form) (v. 3.0)
QI21
Monitoring of Scientific Literature (v. 11.0)
QI21AP03 Individual Search Profile - Azanta Products (v. 5.0)
QI21AP04: Local Literature Monitoring Form for: Azanta (form) (v. 5.0) - Please right-click and chose "Save as"
QI21AP09: MLM ICSR Log (form) (v. 2.0)
QI21AP10: INDIVIDUAL SEARCH PROFILES – LIFE MEDICAL PRODUCTS (form) (v. 2.0)
QI21AP11: Monitoring of PRAC Minutes Life Medical (form) (v. 2.0)
QI21AP12: Individual Search Profiles - Eumedica Products (form) (v. 2.0)
QI21AP13: Individual Search Profiles - Amgros Products (form) (v. 1.0)
QI21AP14: Local Literature Monitoring Form For: EUMEDICA (form) (v. 2.0) - Please right-click and chose "Save as"
QI21AP15: Individual Search Profiles - Pharma Nord (v. 1.0)
QI21AP16: EMA MLM Service - Pharma Nord (v. 1.0)
QI21AP17: Individual Search Profiles - GxMed Nordic (v. 1.0)
QI22
Pharmacovigilance Azanta (v. 8.0)
QI23
Deviations (pharmacovigilance) (v. 4.0)
QI23AP01: Deviation Log (form) (v. 4.0)
QI23AP02: Deviation report (form) (v. 4.0)
QI23AP03: Trend Analysis Report (form) (v. 4.0)
QI24
Reporting Matrix (v. 9.0)
QI24AP01 Reporting Matrix Amgros (v. 2.0)
QI24AP02 Reporting Matrix Azanta (v. 4.0)
QI24AP07 Reporting Matrix Urtekram (v. 2.0)
QI24AP08 Reporting Matrix Life-Medical (v. 1.0)
QI25
Case assessment and Writing Sender's Comments (v. 4.0)
QI26
Registration in EudraVigilance (v. 3.0)
QI26AP01: AMP check list (form) (v. 3.0)
QI26AP02: Check list (administrative information) (form) (v. 3.0)
QI26AP03: Language requirements in XEVMPD (form) (v. 1.0)
QI27
E2B testing (EVWEB) (v. 2.0)
QI28
Handling of Adverse Reports in A-consult (v. 4.0)
QI28AP01: Adverse drug reaction quick guide (v. 2.0)
QI28AP02: Client list (v. 3.0)
QI29
QPPV 24 Hours Accessibility (v. 3.0)
QI30
Safety Management Teams (v. 2.0)
QI30AP01: SMT Guideline (form) (v. 2.0)
QI30AO02: SMT Meeting Minutes (form) (v. 2.0)
QI31
Signal Detection and Evaluation (v. 5.0)
QI31AP01: Signal Evaluation Form (form) (v. 2.0)
QI31AP02: Signal Log (template) (v. 2.0)
QI31AP03: Checklist of Product Data (form) (v. 1.0)
QI31AP04: Activities Tracking Chart (form) (v. 2.0)
QI31AP06: Creation of reports from PV247 for signal detection (form) (v. 1.0)
QI32
Emerging Safety Issues (v. 2.0)
QI33
Safety Communication (v. 2.0)
QI34
Case Handling using PV247 (v. 9.0)
QI34AP01: Triage Form and AE front page (for use with PV247) (form) (v. 2.0)
QI35
QPPV Periodic Report (v. 2.0)
QI35AP01: QPPV Periodic Report (template) (v. 1.0)
QI35AP02: Tracking sheet for QPPV Periodic report (v. 1.0)
QI36
CCSIs (v. 2.0)
QI36AP01: Guidance to content of a CCSI (form) (v. 1.0)
QI40
Monitoring of Scientific Literature for CSL Behring (v. 3.0)
QI40AP01: Individual Search Profiles - CSLB Products (v. 4.0)
QI40AP02: Local Literature Review Log (form) (v. 2.0)
QI41
Pharmacogivilance Life-Medical (v. 3.0)
QI42
Pharmacovigilance AMGROS (v. 5.0)
QI42AP01: Log for monitoring of PV inbox (form) (v. 1.0)
QI43
MedDRA Term selection (v. 1.0)
QI44
Contractual responsibilities - Eumedica (v. 3.0)
QI44AP01 Contact details (v. 2.0)
QI44AP02 Adverse Event Report Form (v. 1.0)
QI45
Regulatory Intelligence (v. 1.0)
QI45AP01: Regulatory Intelligance Check List for PV (medicinal products) (form) (v. 2.0)
QI45AP02: PV Intelligance Tool (form) (v. 1.0)
QI45AP03: Regulatory Intelligence Check List for RA-QA (medical products) (form) (v. 1.0)
QI45AP04: RA & QA Intelligance Tool (form) (v. 1.0)
QI46
Clinical Risk Management Plan (v. 1.0)
QI46AP01: Guidance on format of the risk management plan (RMP) in the EU – in integrated format (v. 1.0)
QI46AP02: Quality Control (QC) of Risk Management Plan (v. 1.0)