Available Now: InfoPV10i

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

Web application Access it from anywhere with a PC ad a browser Comes with flexible hosting options - on our servers or yours.

Contact us at info@makromed.com or 603-890-3311 x300 to conduct a convenient interactive evaluation now, using your existing PC with no demo programs or anything else to download.

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 13 485 standard

General

• It allows managing 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.
• 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 involved.

Process Validation and Test Method Validation

• InfoPV 10i allows creating and maintaining all essential elements of process validations, including:
  • Master Validation Plans and Reports (MVP/MVR)
  • Equipment Qualifications (EQ, IQ)
  • Operation Qualification (OQ - challenge conditions)
  • Performance Qualification (PQ - nominal or normal production conditions)
• Dynamically manages the interdependence of EQ, TMV, OQ, PQ and PPQ elements of validations.
• Supports variable test method validations (VTMV or Gage R&R studies) and attribute test method validations (ATMV or Attribute Agreement studies).
• Includes state-of-the-art statistical methods for PV and TMV, as well as statistical performance and sampling plans.
• Supports process capability studies.

Other Advantages

• Supports attachment of external documents to PV and TMV records.
• It includes powerful smart tools like user configurable workflow rules and eNotifications for efficient and effective management of process and test method validation activities.
• It is fully validated, has comprehensive security features, includes elaborate audit trail functionality and is compliant with 21 CFR Part 11 eRecords and eSignatures regulation.
• It is web-based and can be conveniently accessed globally, including from mobile devices.

Click here to download a brochure on InfoPV 10i Process Validation and Test Method Validation software.