Inquiries:
[email protected]
About Us
Services
Computer Systems Validation
Education & Training
General Consulting
GxP Compliance
Inspection Readiness Program
Nutraceutical Compliance
REDCap Validation
Happenings
News
Events
Resources
Contact Us
Careers
Work with Us
Search
Implementing a Master Validation Program (MVP)
Highlighting the gold standard for the process and procedure of implementing a master validation program.
Event Date:
Tuesday, November 29, 2022
Event Time:
10AM ET
Course Type:
eCourse
Prev
Next
Privacy Preference Center
Privacy Preferences
GET IN TOUCH
CLOSE
CLOSE
SCHEDULE AN INTRO
CLOSE
REQUEST A FACT SHEET
Which fact sheet are you interested in?
Use the arrows to scroll and make a selection. You'll be redirected on submission.
{"columns":"3","minwidth":"0","navigation":false,"dots":false}
All of them
Auditing & Assessment Services
Part 11 Compliance Services
Program Management Services
Project Management & Execution
QAaaS
Software Selection & Implementation
Training & Education Services
Validation Program Management
Field is required!
Field is required!
First Name:
Field is required!
Field is required!
Last Name:
Field is required!
Field is required!
Company / Organization:
Field is required!
Field is required!
Where should we send it?
Enter your email address:
Field is required!
Field is required!
[{"field":"{selection}","logic":"not_equal","value":"","and_method":"","field_and":"","logic_and":"","value_and":""}]
GO
CLOSE
CLOSE
CLOSE
ENTER-TO-WIN
Enter to win in our monthly drawing!
One lucky Grand Prize Winner will receive a
free $100 USD Amazon Gift Card
. Runners Up (2) will receive a Complementary Web Training (30min) or Complementary Consultation (30min).
First Name:
Field is required!
Field is required!
Last Name:
Field is required!
Field is required!
Company / Organization:
Field is required!
Field is required!
Email Address:
Field is required!
Field is required!
Submit
FNAME|firstname LNAME|lastname EMAIL|email MMERGE7|company
CLOSE
GXP ASSESSMENT
First Name:
Field is required!
Field is required!
Last Name:
Field is required!
Field is required!
Company / Organization:
Field is required!
Field is required!
Where are you located?
Field is required!
Field is required!
How would you like to collaborate?
- select a option -
On-site
Virtually
Hybrid
Field is required!
Field is required!
Email:
Field is required!
Field is required!
Phone:
Invalid phonenumber!
Invalid phonenumber!
Which services are you interested in?
Check all that apply.
GLP Services
GCP Services
CSV Services
Field is required!
Field is required!
What type of GLP services do you need?
Select all that apply.
Ad-hoc Resources
Auditing
Training
Other
Field is required!
Field is required!
What type of GLP audits do you need conducted?
Select all that apply.
Vendor Management Audits
Study Specific Audits
Mock Inspections
Other
Field is required!
Field is required!
What other GLP auditing needs do you have?
[{"field":"{glpauditing-needs}","logic":"contains","value":"Other","and_method":"","field_and":"","logic_and":"","value_and":""}]
Field is required!
Field is required!
How many GLP audits do you need conducted? And/or, on what timeline?
Field is required!
Field is required!
[{"field":"{glpneeds}","logic":"contains","value":"Auditing","and_method":"","field_and":"","logic_and":"","value_and":""}]
What type of GLP training do you need?
Field is required!
Field is required!
When do you need GLP training to commence?
Field is required!
Field is required!
[{"field":"{glpneeds}","logic":"contains","value":"Training","and_method":"","field_and":"","logic_and":"","value_and":""}]
Briefly describe the GLP-related needs or specific resource assistance you're looking for:
[{"field":"{glpneeds}","logic":"not_equal","value":"","and_method":"","field_and":"","logic_and":"","value_and":""}]
Field is required!
Field is required!
[{"field":"{services}","logic":"contains","value":"GLP","and_method":"","field_and":"","logic_and":"","value_and":""}]
What type of GCP services do you need?
Select all that apply.
Auditing
Training
Other / Ad-hoc
Field is required!
Field is required!
What type of GCP auditing is required?
Select all that apply.
Vendor Management Audits
Investigator Site Audits
Mock Inspections
Trial Master File Audits
Other
Field is required!
Field is required!
How many GCP audits do you need conducted? And/or, on what schedule?
[{"field":"{gcpneeds-auditing}","logic":"not_equal","value":"","and_method":"","field_and":"","logic_and":"","value_and":""}]
Field is required!
Field is required!
Please describe your 'other' GCP Auditing needs:
Be as detailed as possible.
[{"field":"{gcpneeds-auditing}","logic":"contains","value":"Other","and_method":"","field_and":"","logic_and":"","value_and":""}]
Field is required!
Field is required!
[{"field":"{gcpneeds}","logic":"contains","value":"Auditing","and_method":"","field_and":"","logic_and":"","value_and":""}]
What type of GCP training do you require?
Please be as detailed as possible.
Field is required!
Field is required!
When do you need GCP training to commence? And/or, at what frequency?
Field is required!
Field is required!
[{"field":"{gcpneeds}","logic":"contains","value":"Training","and_method":"","field_and":"","logic_and":"","value_and":""}]
Please detail any additional or 'other' GCP needs you may have, if any:
Optional.
[{"field":"{gcpneeds}","logic":"not_equal","value":"","and_method":"","field_and":"","logic_and":"","value_and":""}]
Field is required!
Field is required!
[{"field":"{services}","logic":"contains","value":"GCP","and_method":"","field_and":"","logic_and":"","value_and":""}]
What computer system validation (CSV) services do you need?
Select all that apply.
Auditing
Product Selection
Other / Something else
Field is required!
Field is required!
What type of CSV auditing services do you need?
System Audits & Validation
Vendor Assessment / Qualification
Other / Ad-hoc
Field is required!
Field is required!
What types of systems need to be validated?
[{"field":"{csvneeds-auditing}","logic":"contains","value":"System Audits","and_method":"","field_and":"","logic_and":"","value_and":""}]
Field is required!
Field is required!
How many systems need to be validated?
[{"field":"{csvneeds-auditing}","logic":"contains","value":"System Audits","and_method":"","field_and":"","logic_and":"","value_and":""}]
Field is required!
Field is required!
How many CSV audits do you need? And, on what schedule?
Field is required!
Field is required!
[{"field":"{csvneeds}","logic":"contains","value":"Auditing","and_method":"","field_and":"","logic_and":"","value_and":""}]
What type of products or systems are you looking for?
Field is required!
Field is required!
Have you already begun your search?
For the product or system.
Yes, I have.
No, I have not.
Field is required!
Field is required!
Are you looking to replace an existing/active product or system?
Yes, I am.
No, I am not.
I don't know.
Field is required!
Field is required!
[{"field":"{csvneeds}","logic":"contains","value":"Product Selection","and_method":"","field_and":"","logic_and":"","value_and":""}]
Please share any additional information as it relates to your CSV needs:
[{"field":"{csvneeds}","logic":"not_equal","value":"","and_method":"","field_and":"","logic_and":"","value_and":""}]
Field is required!
Field is required!
[{"field":"{services}","logic":"contains","value":"CSV","and_method":"","field_and":"","logic_and":"","value_and":""}]
Submit
CLOSE
REDCAP ASSESSMENT
Is your system validated?
Yes
No
Field is required!
Field is required!
Is your system used to create, modify, maintain, store, archive, retrieve or transmit patient Protected Health Information (PHI) under Health Insurance Portability and Accountability Act (HIPAA)?
Yes
No
Field is required!
Field is required!
Does your system use Electronic Records?
Yes
No
Field is required!
Field is required!
Are Electronic Signatures used?
Yes
No
Field is required!
Field is required!
Are the records in electronic form created, modified, maintained, archived, retrieved, or distributed by a computer system?
Yes
No
Field is required!
Field is required!
Are the signatures executed in the system a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature?
Yes
No
Field is required!
Field is required!
Are records protected against intentional or accidental modification or deletion?
Yes
No
Field is required!
Field is required!
Do you have a strategy defined or documented for the backup, restore and retention process? If so, has it been tested?
Yes
No
Field is required!
Field is required!
Does your system have access control?
Yes
No
Field is required!
Field is required!
Do you have policies and procedures to ensure both internal and external security?
Yes
No
Field is required!
Field is required!
Does your system maintain an audit trail that is readily available for an inspection?
Yes
No
Field is required!
Field is required!
Does the system ensure that only authorized individuals can use the system?
Yes
No
Field is required!
Field is required!
Does the system verify that an individual has the authority to electronically sign a record before allowing the individual to do so, or deny access to invalid users?
Yes
No
Field is required!
Field is required!
Do you have documentation to show that people who use the system have the education, training, and experience to perform their assigned tasks?
Yes
No
Field is required!
Field is required!
Do you have a Change Control procedure in place for System upgrades?
Yes
No
Field is required!
Field is required!
Are policies and processes established to certify that an electronic signature is the legally binding equivalent of the signer's handwritten signature?
Yes
No
Field is required!
Field is required!
Is your system used to electronically sign, electronically approve, or electronically archive data-containing regulatory submission documents for investigational or marketing applications to Health Authorities?
Yes
No
Field is required!
Field is required!
Does your system have any impact with respect to patient safety or Product Quality or Business Continuity?
Yes
No
Field is required!
Field is required!
Does your system directly affect the design, conduct, performance, auditing, recording, analyses, and report monitoring of adverse events in clinical studies of investigational products?
Yes
No
Field is required!
Field is required!
Is your system used for collecting, assessing, monitoring, and reporting adverse events for drug products?
Yes
No
Field is required!
Field is required!
Based on your responses, you may be at risk for an FDA audit. But we can help!
Enter your information below and a member of our REDCap team will reach out to assist with making validation simple and seamless.
[{"field":"{one}","logic":"equal","value":"Yes","and_method":"or","field_and":"{two}","logic_and":"equal","value_and":"Yes"},{"field":"{five}","logic":"equal","value":"Yes","and_method":"or","field_and":"{six}","logic_and":"equal","value_and":"Yes"},{"field":"{seven}","logic":"equal","value":"Yes","and_method":"or","field_and":"{eight}","logic_and":"equal","value_and":"Yes"},{"field":"{ten}","logic":"equal","value":"Yes","and_method":"or","field_and":"{thirteen}","logic_and":"equal","value_and":"Yes"},{"field":"{sixteen}","logic":"equal","value":"Yes","and_method":"or","field_and":"{seventeen}","logic_and":"equal","value_and":"Yes"},{"field":"{nineteen}","logic":"equal","value":"Yes","and_method":"or","field_and":"{twenty}","logic_and":"equal","value_and":"Yes"}]
Thanks for completing the assessment.
Enter your information below and a member of our REDCap team will reach out to discuss ways we may be able to assist in making validation simple and seamless.
[{"field":"{one}","logic":"equal","value":"Yes","and_method":"or","field_and":"{two}","logic_and":"equal","value_and":"Yes"},{"field":"{five}","logic":"equal","value":"Yes","and_method":"or","field_and":"{six}","logic_and":"equal","value_and":"Yes"},{"field":"{seven}","logic":"equal","value":"Yes","and_method":"or","field_and":"{eight}","logic_and":"equal","value_and":"Yes"},{"field":"{ten}","logic":"equal","value":"Yes","and_method":"or","field_and":"{thirteen}","logic_and":"equal","value_and":"Yes"},{"field":"{sixteen}","logic":"equal","value":"Yes","and_method":"or","field_and":"{seventeen}","logic_and":"equal","value_and":"Yes"},{"field":"{nineteen}","logic":"equal","value":"Yes","and_method":"or","field_and":"{twenty}","logic_and":"equal","value_and":"Yes"}]
First Name:
Field is required!
Field is required!
Last Name:
Field is required!
Field is required!
Company / Organization:
Field is required!
Field is required!
Email:
[email protected]
Field is required!
Field is required!
Is there anything else you'd like to share?
Optional.
Field is required!
Field is required!
SUBMIT
CLOSE
WORK WITH US
First Name (Legal):
First Name
Field is required!
Field is required!
Last Name (Legal):
Last Name
Field is required!
Field is required!
Email:
[email protected]
Field is required!
Field is required!
Phone Number:
+1 000-000-0000
Field is required!
Field is required!
Desired Position:
- select a option -
Account Representative (Sales)
Clinical Practice Auditor
Computer Validation Auditor
General Compliance Expert
Lab Practice Auditor
Manufacturing Practice Auditor
- select a option -
Field is required!
Field is required!
Desired Term:
- select a option -
Contract
Full-Time (Regular)
Part-Time (Regular)
- select a option -
Field is required!
Field is required!
Cover Letter:
Upload your cover letter. Max Size: 10MB
Upload your documents...
Field is required!
Field is required!
Resume:
Upload your resume. Max file size: 10MB.
Upload your documents...
Field is required!
Field is required!
Is there anything else we should know when reviewing your application?
Have we met before? Did someone refer you? You can leave all of that here.
Field is required!
Field is required!
Submit
CLOSE
