PV-Works (vet) Regression Test Plan v4.1.2
PV-Works (vet) / regression /v4.1.2 / test plan v1.0
17 February 2012
Contents
1 Introduction 2
2 Test Identification 2
3 Case Data 6
4 Regression Test Forms 18
5 Utility Tests 20
6 File Menu 21
7 Data Tests 26
8 Tasks 31
9 External Menu 34
10 Data Entry 36
11 Reports 71
12 Main Grid 82
13 Electronic Reporting 85
14 Product Quality Complaint 87
15 Authorisation 92
16 Document History 92
1 Introduction
In addition to the formal acceptance testing completed on the latest version of PV-Works (vet), this Regression Test Plan is available to provide a set of general tests to be executed against each release to confirm that changes made since the previous release have not had an adverse impact on other areas of the application.
The tests within this plan are wide ranging, and are intended to confirm broad, correct functional performance. These tests are not in depth tests of new functionality – such testing being covered within the release-specific Acceptance Test Plan.
2 Test Identification
Each test will be assigned a unique test number, which has the format AAA NN, where AAA is a three character code that denotes the functional area under test and NN is a sequential number. The functional codes are:
Code / Description / Specification Reference / BridgeTrak NumberLog / Logging On / 4, 5.5, 19.2.1
BQY / Build a Query / 19.2.2, 5.2.1, 5.2.3, 5.2.5, 11.6
FNC / Find Case / 19.2
CPY / Copy Case / 19.11
DLC / Delete Case / 19.6, 6.4
CHP / Change Password / 24.2
LKC / Lock Case / 19.5
CLC / Close Case / 19.6
FEX / Forced Exit / 5.6
VER / Version Case / 19.7
CMC / Compare Case / 19.8
EXT / Exit PV-Works / 5.6
NEW / New Case / 6.2, 6.2.1
RVW / Review Case / 7.9, 7.9.1
NRS / Narrative Summary / 8.5
CAN / Case Number Assignment / 6.2.2
LNK / Link Case / 19.10
RWA / Review with Audit Trail / 6.4.3
EQP / Equivalent Products / 8.1, 10.5, 11.8.2
UPD / Update Case / 11.3, 15.6, 6.3.1
DPC / Duplicate Check / 6.2.4
VDC / VedDRA Coding / 8.2, 8.2.1, 8.2.2, 8.2.3
WLM / Workload Manager / 17.5
CAP / Create Ad-hoc Process / 17.4
TDL / To Do List / 17.3, 19.2
RAB / Review Action Board Activities / 17.8
CSA / Case Actions / 17.6
LMS / Lot Search / 19.3.1
LET / Letters / 13.1, 13.3.1
ECS / External Contact Search / 19.3.2
CAS / Case Entry / 6.2.1
ASS / Assessment Screen / 9.1, 9.2, 9.3, 9.3.1, 9.4
PAT / Patient Screen / 7.3, 7.3.3, 7.3.4
HLP / Help / 19.12
MAF / Mandatory Fields / 6.3.6
IPR / Issue Product Screen / 14.7.1
ICN / Data Entry Icons
CID / Case Identification / 6.3.3, 7.1
EVN / Event Narrative Screen / 7.5, 8.3, 13.4
IPY / Issue Payment Screen / 14.7.1
SCN / Send Case Notification / 11.10.2, 10.8.2
CON / Contacts Screen / 7.2
LAB / Laboratory Tests screen / 7.6
SLT / Send Literature Screen / 14.6, 14.6.1, 14.6.2, 14.7
NEW / New Case / 6.2, 6.2.1
PRS / Products Screen / 7.4, 7.4.1
CLH / Call History Screen / 7.8, 19.1, 19.3, 6.3.7
SLB / Send Laboratory Box / 17.3
PIP / Pipeline / 6.2.3
PRI / Product Investigations / 7.4, 15.2, 15.3
DCM / Document Management / 18, 18.1, 18.2, 18.2.1, 18.2.2
RRP / Regulatory Reports Screen / 7.7, 10.3.3, 10.3, 10.7.1 to 10.7.8, 11.10.5
CAH / Call Handover / 14.5.4
FDA / FDA Report / 10.7.4
CFR / CFIA Report / 10.7.2
CSR / Case Summary Report / 10.8.1, 10.8
PSU / PSUR / 11.8, 11.8.1, 11.8.3, 11.9, 11.9.1, 11.10.1, 11.10.2, 11.10.3, 11.10.4, 19.2.3, 11.5, 12.4, 11.6
CVM / CVMP Report / 10.7.5
SAR / South African Report
ATR / Audit Trail Report / 6.4.4
EXS / Expedited Submission / 11.3, 11.3.1, 11.4, 11.7
USD / USDA Report / 10.7.10
AUR / Australian Veterinary Report / 10.7.1
CRR / Crystal Report / 19.4
BAT / Batch Printing of Single Case Reports / 11.1
MGR / Main Grid / 5.2, 5.2.1, 5.2, 5.2.2, 5.2.3, 5.2.4, 5.2.5, 5.2.6, 5.2.7, 5.2.8
ETR / Electronic Reporting / 12.2.1, 12.2.2, 12.2.3, 12.2.4, 12.2.5
PQC / Product Quality Complaint / 15.4.2, 15.6, 15.6.1, 15.6.2, 15.6.3, 15.6.5, 15.6.6, 15.6.7, 15.7, 15.11
3 Case Data
Case S1: Spontaneous Case - Simple CaseCase Identification
Case type / Animal Complaint / Did the source ..Send to the domestic HA? / Suspect Duplicate CaseInformation Type / Confirmed AE Report / Source / Attending Veterinarian / Medically Substantiated
Reference Number I / Method / Received by email / Complaint Types
Reference Number II / Date Received / <Today> / Study Identifier
Case Owner / <Default> / Date First Valid / <Today> / Study Title
Responsible / <Default> / Date latest follow up / Study Type
Country Where Event Occurred / USA / Potential Litigation
Contacts
Contact # 1
Case role / Attending Veterinarian / Fax / State / County / WisconsinTitle / Mr / Mobile / 608-513-9815 / Zip / Post code / 53701
First name / Ollie / Home / Country / US
Surname / Garmi / Company / clinic / First Contact / Y
Suffix / Address / Primary Reporter / Y
E-mail / / Address line 2 / Account Number
Phone / City / Madison
Contact # 2
Case role / Owner/Producer/Employee / Fax / State / County / MichiganTitle / Mr / Mobile / Zip / Post code / 48916
First name / Ray / Home / Country / US
Surname / Violi / Company / clinic / First Contact / N
Suffix / Address / 15 Longstanton Road / Primary Reporter / N
E-mail / / Address line 2 / Account Number
Phone / (517) 303-6128 / City / Lansing
Patients
Patient # 1
Species / Bovine / Approx / If so which?Breed / Beef Cattle / Weight (text) / Total / 126
Mixed / Date of Birth / Exposed / 126
ID Name / Age (from) / 2 Weeks / Reacted / 54
Sex / Mixed / Age (to) / 3 Years / Recovered / 36
Sex Qualifier / Approx / Y / Euthanised / 0
Production Type / Condition on animal prior to treatment / Died / 6
Weight (from) / Did you illness develop after dose? / Under Treatment / 12
Weight (to) / Details / Alive with Sequelae / 0
Weight Unit / Had animal previously reacted to other drugs? / Unknown / 0
Patient # 2
Species / Bovine / Approx / If so which?Breed / Dairy Cattle / Weight (text) / Total / 40
Mixed / Date of Birth / Exposed / 40
ID Name / Age (from) / 8 Months / Reacted / 15
Sex / Female / Age (to) / 6 Years / Recovered / 15
Sex Qualifier / Approx / Euthanised / 0
Production Type / Condition on animal prior to treatment / Died / 0
Weight (from) / Did you illness develop after dose? / Under Treatment / 0
Weight (to) / Details / Alive with Sequelae / 0
Weight Unit / Had animal previously reacted to other drugs? / Unknown / 0
Products
Product # 1
Product Role / Suspect / Per / 1 Day / DetailsCompany Product / Yes / Dose (text) / Has patient reacted to this product before?
Generic Name / AlphaCream / Time to Onset first dose / 1 / Details
Brand Name / AlphaCream US / Time to Onset first dose unit / Day / Time to Onset (text) / N/A
Formulation / Tablet / Time to Onset last dose / Has vet seen similar reaction to this before
Strength / 100mg / Time to Onset last dose unit / Details
Product Problem type / Adverse Reaction / Route / Attending Vet’s Level of Suspicion
Dose Start Date / <Today minus 50 days> / Site of Admin / Product Lot# / 50B/4599
Dose End Date / <Today minus 10 days> / Administered by / Qualifier
Duration / 5 weeks 4 days / Reason for Use / Expiry Date
Duration (Text) / LOE Reason / Serial #
Dose / 100 / Was Product Used Correctly? / Diluent #
Dose Unit / Mg / Misuse Types
Frequency / 1 / Has patient had this product before?
Product # 2
Product Role / Concomitant / Per / 1 Day / DetailsCompany Product / No / Dose (text) / Has patient reacted to this product before?
Generic Name / Amoxycillin / Time to Onset first dose / Details
Brand Name / Time to Onset first dose unit / N/A
Formulation / Capsule / Time to Onset last dose / Has vet seen similar reaction to this before
Strength / 250mg / Time to Onset last dose unit / Details
Route / Oral / Attending Vet’s Level of Suspicion
Dose Start Date / Site of Admin / Product Lot#
Dose End Date / Administered by / Qualifier
Duration / Reason for Use / Expiry Date
Duration (Text) / LOE Reason / Serial #
Dose / 750 / Was Product Used Correctly? / Diluent #
Dose Unit / Mg / Misuse Types
Frequency / 3 / Has patient had this product before?
Product # 3
Product Role / Concomitant / Per / 1 Day / DetailsCompany Product / No / Dose (text) / Has patient reacted to this product before?
Generic Name / Levodopa / Time to Onset first dose / Details
Brand Name / Time to Onset first dose unit / Time to Onset (text)
Formulation / Tablet / Time to Onset last dose / Has vet seen similar reaction to this before
Strength / Time to Onset last dose unit / Details
Product Problem type / Route / Oral / Attending Vet’s Level of Suspicion
Dose Start Date / Site of Admin / Product Lot#
Dose End Date / Administered by / Qualifier
Duration / Reason for Use / Expiry Date
Duration (Text) / LOE Reason / Serial #
Dose / 125 / Was Product Used Correctly? / Diluent #
Dose Unit / Mg / Misuse Types
Frequency / 1 / Has patient had this product before?
Event Narrative
End Date / <Default> / Was the Adverse Reaction Treated? / And the reaction
Ongoing / Outcome of Reaction to date / Reaction Type
Duration / <Default> / Abstract Summary
Narrative / Lethargic, droopy, fever of 103 degrees the day following treatment. Animals do not want to move or eat.
Adverse Event (Clinical Signs)
Event 1
Verbatim / Lethargy / Duration / 5 Weeks 4 Days / Time to Onset last doseStart Date / <Today minus 49 days> / Duration (Text) / Time to Onset last dose unit
End Date / <Today minus 10 days> / Time to Onset first dose / 1 / Qualifier
Ongoing / Time to Onset first dose unit / Day
Event 2
Verbatim / Fever / Duration / 5 Days / Time to Onset last doseStart Date / <Today minus 48 days> / Duration (Text) / Time to Onset last dose unit
End Date / <Today minus 43 days> / Time to Onset first dose / 2 / Qualifier
Ongoing / Time to Onset first dose unit / Day
Laboratory Tests
Laboratory Test Details # 1
Test Name / Cortisol / Result / 21.5 / LowDate / <today – 37 days> / Result Unit / Mg/l / High
Time / 10:30:00 / Abnormal / Note
Laboratory Test Details # 2
Test Name / Glucose, unspecified / Result / 12.1 / LowDate / <today – 37 days> / Result Unit / Mg/l / High
Time / Abnormal / Note / Urine analysis on <today – 35 days> reported to be normal. Ca++ 23mg/l; K 0.7mg/l; Mg 19mg/l; SO4 13mg/l; pH 7.4
Assessment
Case - Serious / Y / Case - reportability / 15 DayCase - Expected / N / Agency / Food & Drug Administration
Product # 1 – AlphaCream US
Expected / N / Reason for Assessment / Dechallenge / Did not abateAssessment / Possible / Medium / Rechallenge / No Recurrence
Case S2: Involved Spontaneous Case – Includes Follow-up Information
Case Identification
Case type / Animal Complaint / Did the source ..Send to the domestic HA? / Suspect Duplicate CaseInformation Type / Confirmed AE Report / Source / Medical Physician / Medically Substantiated
Reference Number I / Method / Phone Call / Complaint Types
Reference Number II / Date Received / <Today> / Study Identifier
Case Owner / <Default> / Date First Valid / <Today> / Study Title
Responsible / <Default> / Date latest follow up / Study Type
Country Where Event Occurred / USA / Potential Litigation
Contacts
Case role / Medical Physician / Fax / (208) 362-7665 / State / County / IdahoTitle / Mr / Mobile / Zip / Post code / 83703
First name / Mitch / Home / Country / US
Surname / Ellinman / Company / clinic / Mitchellin Medicines / First Contact / Y
Suffix / Address / 161 Long Road / Primary Reporter / Y
E-mail / / Address line 2 / Account Number
Phone / (208) 362-7664 / City / Boise
Patients
Species / Canine / Approx / If so which?Breed / Australian Sheepdog / Weight (text) / Total / 1
Mixed / Date of Birth / Exposed / 1
ID Name / Age (from) / 4 Years / Reacted / 1
Sex / Male / Age (to) / Recovered / 1
Sex Qualifier / Approx / Euthanised
Production Type / Condition on animal prior to treatment / Died
Weight (from) / Did you illness develop after dose? / Under Treatment
Weight (to) / Details / Alive with Sequelae
Weight Unit / Had animal previously reacted to other drugs? / Unknown
Products
Product 1
Product Role / Suspect / Per / 1 Day / DetailsCompany Product / Yes / Dose (text) / Has patient reacted to this product before?
Generic Name / Chlorbenoride / Time to Onset first dose / 3 / Details
Brand Name / Chlorbenoride US / Time to Onset first dose unit / Days / Has vet seen similar reaction to this before
Formulation / Injection / Time to Onset last dose / 1 / Details
Strength / 20ml / Time to Onset last dose unit / Day / Attending Vet’s Level of Suspicion
Product Problem type / Adverse Reaction / Route / Product Lot# / 22C-EE
Dose Start Date / <Today minus 4 days> / Site of Admin / Qualifier
Dose End Date / <Start date plus 2 days> / Administered by / Expiry Date
Duration / 2 days / Reason for Use / Serial #
Duration (Text) / LOE Reason / Diluent #
Dose / 40 / Was Product Used Correctly?
Dose Unit / Mg / Misuse Types
Frequency / 1 / Has patient had this product before?
Event Narrative