Regulatory
Validation Pack
By
Jul 31, 2005, 09:05

Benefits of Pilgrim's Valpack

• Cost Effective - You can save up to 90% of your software validation costs using Pilgrim ValPack.
  
  
• Knowledge - Knowledgeable Pilgrim Software Validation Specialists, certified in Pilgrim Solutions, create the  Validation Pack to assure correct functionality and thorough system testing.
  
  
• Speed - The time spent implementing Pilgrim ValPack greatly reduces the validation effort. The typical module validation, which includes creating and executing test protocols, can be achieved in 30 days with Pilgrim ValPack rather than the estimated 5-8 months without it.
  
  
• Maintenance - Pilgrim maintains and supports its ValPack throughout the software life cycle. FDA regulated companies must become compliant and must remain compliant for each subsequent release. This means that for each hotfix, service pack and major/minor upgrade, you must validate that portion of the system that has changed to assure accuracy in your  environment. 
   

Off-the-Shelf Software Validation

Realizing that the intended use of off-the-shelf software varies from user to user, the FDA has placed the validation responsibility for off-the-shelf software packages on the user to ensure that the application is suitable for its intended use and complies with 21 CFR Part 11.

Life science companies have three options to validate this off-the-shelf software:

1. Do-It-Yourself by developing your own validation test protocols. This option typically takes more than 6 months. The do-it-yourself validation process lays a burden on valuable internal resources.
   
   
2. Hire a Consultant to create validation test protocols. This option typically takes more than 3 months and the cost can be up to three times higher than the cost of the entire software system. The most cost effective way of utilizing validation consultants is to work with them to execute validation test protocols purchased from the software vendor.
   
   
3. Purchase comprehensive validation test protocols created and maintained by the software vendor. Recommended! Pilgrim ValPack is available NOW and is cost effective, quick and easy. Pilgrim also partners with reputable validation consulting firms that can be engaged to execute  Pilgrim ValPack fast and cost effectively.
   

“As a small company, Animas has a limited number of resources available to validate and maintain software systems to meet 21 CFR Part 11 compliance requirements. Pilgrim ValPack not only helped our initial validation efforts, but will assist in future validation because of the Pilgrim validation maintenance program.” Doug Woodruff, VP of RA/QA, Animas Corporation

Regulatory Compliance and Software Validation

Pilgrim Software is the only software vendor that offers a complete and modular suite for regulatory compliance and quality management. Through partnership with our innovative life science customers since the 1990s, Pilgrim Software pioneered electronic signatures, audit trail, and comprehensive off-the-shelf validation scripts to meet US and international industry and regulatory requirements including the FDA’s 21 CFR Part 11.

Pilgrim has developed a suite of Validation Packs to assist customers to validate the Pilgrim solutions. These ValPacks, which satisfy the guidelines set out by the FDA and GAMP4, are a collection of protocols and test matrices for functions accessible to a user within the Pilgrim solutions.


Pilgrim supports you throughout while you are validating the entire solution. During installation, Pilgrim supports you with the:         

• Installation Qualification (IQ). Ensures that the solution is installed in the proper way.
  

Once the solution is installed, Pilgrim ValPack ensures that the software is performing as intended. It includes:

• Operational Qualification (OQ). Establishes documented evidence that operating characteristics perform within the limits and specifications defined for the system.
  
  
• Performance Qualification (PQ). Allows conversion of the OQ to PQ to establish documented evidence of consistent performance defined for the system.
  
  
• Maintenance Qualification (MQ). Manages the change control to maintain compliance.
  
  
• Traceability Matrix (TM). Supports the test program design with test traceability.
  
  
• Functional Requirement Specifications (FRS). Provides design and test traceability.

Pilgrim Valpack is Supported by the Leaders of the Life Science Industry

Pilgrim Software is the first to support life science companies to turn compliance into profits and strategic advantage. Since the 1990s, Pilgrim has partnered with the most innovative and prestigious life science companies to develop its internationally acknowledged, modular Compliance and Quality Management Software Suite. Pilgrim remains the only company to offer a comprehensive, maintained, off-the-shelf solution.

Pilgrim has experienced a fast and steady growth as the world leader for Compliance and Quality Management Software for the Life Science Industry. The quality of this growth is guaranteed by our Life Science Board of Advisors and Industry Forums. They represent the most advanced and prestigious companies in Pharmaceutical, Blood, Tissue and Medical Devices. The Board and Forums contain a user group, user council, product advisory board, and executive level vision team.

Through the Board and Forums, managers, executives and leaders in the Life Science Industry provide Pilgrim with regular feedback on the changing needs in the industry; this helps Pilgrim keep its advanced solutions up-to-date. Members of the Board and Forums can speak directly with each other so that they can share best practices on the use of Pilgrim Solutions.

Savings with Pilgrim Valpack

The return on investment (ROI) with our ValPack can be over five times greater than the “Do-It-Yourself” option, and over ten times greater than the “Hire A Consultant” option. This calculation is based on Pilgrim ValPack list price. Time costs using Pilgrim ValPack is typically less than a month, compared to possibly more than 6 months for the “Do-It-Yourself” option.


More Information

• Request a free brochure with more information about Pilgrim Valpack
• Take a look at our Webinar library and get first hand information from leading companies in your indutry how they overcome the most important challenges with Pilgrim Solutions

The Integrated Compliance Platform

Pilgrim’s ValPack is a fully-integrated part of the Pilgrim Software’s Enterprise Compliance and Quality Platform. Pilgrim Software provides an enterprise–wide solution for managing corrective and preventive actions, complaint handling, change control management, internal and external audits, document control, SOP enforcement, engineering collaboration, employee certification and training, equipment/calibration, supplier quality management, advanced quality planning and risk management. This powerful solution enables you to manage quality and compliance across your entire business, helping you meet regulatory requirements, increase efficiency and reduce costs.