- 1 -

11

- 2 -

21

21CFR11

- 7 -

70

- A -

added

additional

allow

anything

are there restrictions on the number of users

assessments

- C -

CFR

client

company

compliant

computer

containing

content

corporate standards

- D -

database

define

demonstration

desktop

deviation

documents

does

	Our organization does not have any validation standards (we are a small biotech startup) but we need them! Can we use your existing templates as a basis to help define our new requirements?
	Our organization does not allow electronic execution of protocols. Is this a requirement for use of the program?

- E -

electronic

	When you electronically execute protocols, how do you handle screenshots?
	Our organization does not allow electronic execution of protocols. Is this a requirement for use of the program?

electronic signatures

example

exceed

Excel

execution

	When you electronically execute protocols, how do you handle screenshots?
	Our organization does not allow electronic execution of protocols. Is this a requirement for use of the program?
	Can FastVal be used just for Protocol Execution or Deviation Tracking?

existing

	Our organization does not have any validation standards (we are a small biotech startup) but we need them! Can we use your existing templates as a basis to help define our new requirements?
	How does FastVal use our existing company templates?

- F -

folder

formal

format

- G -

generate

gif

- H -

have

- I -

install

install FastVal

	How is FastVal installed?
	Can I install FastVal myself?

install FastVal myself

installation

installed

- J -

jpeg

just

- L -

login

- M -

maintenance

management

master

meet

meet corporate standards

- N -

need

net

no

not

	Our organization does not have any validation standards (we are a small biotech startup) but we need them! Can we use your existing templates as a basis to help define our new requirements?
	Our organization does not allow electronic execution of protocols. Is this a requirement for use of the program?

number of users

- O -

offer

only

- P -

Part

permissions

plans

policy

project

protocol

protocol execution

protocols

- R -

registry

requirements

	Our organization does not have any validation standards (we are a small biotech startup) but we need them! Can we use your existing templates as a basis to help define our new requirements?
	Our organization requires additional documents, including validation master plans, user requirements specifications, vendor assessments, unit tests, etc. Can these and other documents also be generated by the program?
	We have rigid requirements for the content, structure and format of our documents. Can your program meet these requirements?

restrictions

rigid

- S -

screenshot

screenshots

see

service

	Are service plans available for maintenance of FastVal?
	What does the FastVal software service plan include?

service plan

	Are service plans available for maintenance of FastVal?
	What does the FastVal software service plan include?

service plan cover

	Are service plans available for maintenance of FastVal?
	What does the FastVal software service plan include?

service plan include

	Are service plans available for maintenance of FastVal?
	What does the FastVal software service plan include?

services

software

	Is this software fully compliant with 21 CFR Part 11, Electronic Records and Signatures?
	What does the FastVal software service plan include?
	I'd like to see the software. How can I arrange a live demonstration?

sort

spreadsheet

standardize validation practices

standards

strict

structure

submitting your question to our help system

support

system

- T -

technical

templates

	Our organization does not have any validation standards (we are a small biotech startup) but we need them! Can we use your existing templates as a basis to help define our new requirements?
	How does FastVal use our existing company templates?

tests

tools

	What sort of project management tools does FastVal have?
	Does Ofni Systems have any tools for database validation?
	Does Ofni Systems have any tools for Excel spreadsheet validation?
	Does Ofni Systems have any tools for website validation?

tracking

type

- U -

unit

user

userid

users

	Are there restrictions on the number of users?
	Why does every user require a login?

- V -

validation

	Do you offer validation services?
	Our organization does not have any validation standards (we are a small biotech startup) but we need them! Can we use your existing templates as a basis to help define our new requirements?
	Our organization requires additional documents, including validation master plans, user requirements specifications, vendor assessments, unit tests, etc. Can these and other documents also be generated by the program?
	Does Ofni Systems have any tools for database validation?
	Does Ofni Systems have any tools for Excel spreadsheet validation?
	Does Ofni Systems have any tools for website validation?

Validation Methodology

validation practices

validation standards

vendor

- W -

web

website

why do I use electronic signatures

why do users require login

why does every user require a login