InfoPV 10i

Process Validation (PV) and Test Method Validation (TMV) Software

InfoPV 10i is a comprehensive software solution for managing both process validations and test method
validations in accordance with the FDA's 21 CFR Part 820.75 regulation and ISO 13485 standard.

InfoPV 10i provides a holistic approach to process validation,

starting with a high level view of the entire manufacturing line for a
product family and then zooming into the individual process steps

InfoPV allows for management of all validation activities to

establish that:
? A process consistently produces an output that meets its
predetermined requirements.
? The overall manufacturing line produces a product that meets
the finished product requirements.

MVP

Process Output 1

InfoPV 10i allows creating and maintaining all essential Input 1 Step 1

elements of process validations, including: Input 2

Process
Step 2
Output 2

EQ, OQ, PQ &

? Master Validation Plans and Reports (MVP/MVR) Pr
Sp oce s
ec s
s Process Output
TMV
Step
? Equipment Qualifications (EQ, IQ) Pr
Input

Sp oces
? Operation Qualification (OQ – challenge conditions) ec s
s

? Performance Qualification (PQ – nominal or normal Pr Process Output n

Sp oce s Step n
production conditions) ec s Input n
s
Product
Specs

PPQ
MVR

InfoPV 10i dynamically manages the interdependence of EQ,

TMV, OQ, PQ and PPQ elements of validations.

InfoPV:
Is fully validated
?
Has comprehensive security features
?
Includes elaborate audit trail functionality
?
Is compliant with 21 CFR Part 11 eRecords and eSignatures
?
regulation
Allows attachment of external documents to PV and TMV
?

www.makromed.com email: info@makromed.com tel: 603-890-3311

 InfoPV 10i also includes:
Risk-based statistical performance and sampling plans for PV
and TMV.

Both attribute and variable data types.

Variable test method validations (VTMV or Gage R&R studies)

and attribute test method validations (ATMV or Attribute
Agreement studies).

Process capability studies.

Sampling Plan Master File

InfoPV also has powerful user-configurable smart tools such

as:
? Workflow rules
? eNotifications
? PV and TMV metrics and trends for management reviews

All of these ensure efficient and effective management of

process and test method validation activities.

InfoPV 10i includes the ability to reopen records to add new

information, along with the reopen history of the record.

The “Copy Existing Record” function makes it easy to create

a new PV or TMV file that is very similar to an existing file by
copying data with the click of a button.

InfoPV 10i is web-based and can be conveniently accessed

globally, including from mobile devices.
Main Page of an MVP/MVR Record

88 Stiles Road
Salem, NH 03079 USA
tel: 603-890-3311
fax: 603-890-3322
email: info@makromed.com
web: www.makromed.com