New Computer System Validation Templates and Procedures Suites

Kymanox is happy to announce our new templates and procedures suites for Computer System Validation (CSV). We have CSV suites for Biotech & Pharma, and one specifically for Medical Devices.

These suites have been developed based on our broad range of experience validating computer systems for both pharmaceutical and medical device companies.

Here's what the Standard CSV package contains:

• Overall Validation Process (20 pages)
• Validation Project Plan Procedure & Template (9 & 10 pages)
• User Requirements Specification Procedure & Template (10 & 8 pages)
• Software Requirements Specification Procedure & Template (19 & 12 pages)
• Risk Assessment Procedure & Template (8 pages & Spreadsheet)
• Software Design Specification Procedure & Template (17 & 11 pages)
• Traceability Analysis Procedure & Template (8 pages & Spreadsheet)
• Design Review Procedure & Template (7 & 4 pages)
• Change Control Procedure & Template (17 & 3 pages)
• Commissioning Protocol Procedure (6 pages)
• Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Procedure & Template (8 & 13 pages)
• Installation Qualification Template (2 pages)
• Operational Qualification Template (2 pages)
• Performance Qualification Template (2 pages)
• Performance Qualification Template (2 pages)
• Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Summary Report Template (5 pages)
• Exception Reporting Procedure & Template (16 & 2 pages)
• Validation Monitoring Procedure & Template (12 & 4 pages)

Here's what the Medical Device CSV package contains:

• Overall Validation Process (20 pages)
• Validation Project Plan Procedure & Template (9 & 10 pages)
• User Requirements Specification Procedure & Template (10 & 8 pages)
• Software Requirements Specification Procedure & Template (19 & 12 pages)
• Part 11 Assessment Procedure (12 pages)
• Risk Assessment Procedure & Template (8 pages & Spreadsheet)
• Software Design Specification Procedure & Template (17 & 11 pages)
• Traceability Analysis Procedure & Template (8 pages & Spreadsheet)
• Design Review Procedure & Template (7 & 4 pages)
• Change Control Procedure & Template (17 & 3 pages)
• Commissioning Protocol Procedure (6 pages)
• Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Procedure & Template (8 & 13 pages)
• Installation Qualification Template (2 pages)
• Operational Qualification Template (2 pages)
• Performance Qualification Template (2 pages)
• Performance Qualification Template (2 pages)
• Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Summary Report Template (5 pages)
• Exception Reporting Procedure & Template (16 & 2 pages)
• Validation Monitoring Procedure & Template (12 & 4 pages)
  

CMO of the Day - Boehringer Ingelheim

I am starting a new Blog attack - one blog post per weekday until I get through the entire list of CMOs on our Biopharma CMO Search Engine, CMOLocator.

My first CMO of the day is Boehringer Ingelheim.

As one of the leading companies for the contract manufacturing of biopharmaceuticals, Boehringer Ingelheim offers the entire production technology chain in development and production at its facilities in Biberach (Germany) and Vienna (Austria). Their large scale manufacturing sites deliver biopharmaceutical products like therapeutic proteins, fusion proteins, protein scaffolds, monoclonal antibodies, antibody mimetics and plasmid DNA.

We have listings for 27 of their production lines on our CMO search engine:

Boehringer Ingelheim Biberach Train 1

Boehringer Ingelheim Biberach Train 2

Boehringer Ingelheim Biberach Train 3

Boehringer Ingelheim Biberach Train 4

Boehringer Ingelheim Biberach Train 5

Boehringer Ingelheim Biberach Train 6

Boehringer Ingelheim Biberach Train 7

Boehringer Ingelheim Vienna Microbial Train 1

Boehringer Ingelheim Vienna Microbial Train 2

Boehringer Ingelheim Vienna Microbial Train 3

Boehringer Ingelheim Vienna Microbial Train 4

Boehringer Ingelheim Vienna Microbial Train 5

Boehringer Ingelheim Vienna Microbial Train 6

Boehringer Ingelheim Biberach Fill/Finish Pilot Line 1

Boehringer Ingelheim Biberach Fill/Finish Pilot Line 2

Boehringer Ingelheim Biberach Fill/Finish Pilot Line 3

Boehringer Ingelheim Biberach Fill/Finish Pilot Line 4

Boehringer Ingelheim Biberach Fill/Finish Pilot Line 5

Boehringer Ingelheim Biberach Fill/Finish Pilot Line 6

Boehringer Ingelheim Biberach Fill/Finish Pilot Line 7

Boehringer Ingelheim Biberach Fill/Finish Pilot Line 8

Boehringer Ingelheim Biberach Fill/Finish Pilot Line 9

Boehringer Ingelheim Biberach Fill/Finish Pilot Line 10

Boehringer Ingelheim Biberach Fill/Finish Line 1

Boehringer Ingelheim Biberach Fill/Finish Line 2

Boehringer Ingelheim Biberach Fill/Finish Line 3

Boehringer Ingelheim Biberach Fill/Finish Line 4

cGDP and cGMP Training Packages

Our Introduction to cGDP Current Good Documentation Practices and Introduction to cGMP Current Good Manufacturing Practices Training Packages have been selling very well in the last few months! More and more companies are recognizing the value of using our training packages to get their employees up to speed on GMP and GDP practices in a very efficient, inexpensive way. Why hire an outside consultant to teach you the concepts when you download our training packages at a fraction of the cost?



Our online store offers templates for Pharma, Biotech and Medical Devices, Standard Operating Procedures for things like Riboflavin Coverage Test, Data Recording Standards, pH & Conductivity Meters and many more. We also offer classroom courses in technology transfer for Biopharmaceuticals, and technical presentations on cutting edge topics.

Visit our store at www.kymastore.com today and see how much time you can save on your next project!

Regulatory Audit Checklist

Our fantastic regulatory audit checklist and scorecard is on sale for $300 (a savings of $100) for the remainder of this week.

This template package features a comprehensive audit checklist and scorecard that can be used to perform internal and external audits of facilities following FDA, ISO, & EU regulations.

If you are working on a biotech, pharmaceutical or medical device regulatory audit, this checklist provides the following:

• The checklist can be utilized to complete internal or external audits of licensed facilities which are required to follow the ISO, FDA, and EU regulations outlined in the document.
• The checklist is broken into 21 independent audit elements (each with its own tab in the spreadsheet).
• Each element contains a series of questions that correspond to and are cross-referenced by several well-known regulations.
• Each question is assigned a weight, from "Minor" to "Critical", which corresponds to the relative significance of the question and the subsequent requirements. The higher the number, the higher the significance.
• Guide Notes are provided to ensure that the user of the checklist has relevant examples of the regulatory requirement.
• The user of the checklist completes each audit element by filling out the scores for the 21 elements. The user will score the auditee for each question, providing a numerical value equal to the weight when the auditee has shown evidence of meeting the full intent of the regulatory requirement. The user will subsequently record scores based on the responses, down to a zero(0) if the auditee is not meeting the intent of the regulation.
• Upon completion of the checklist, it is recommended that the user capture objective evidence for each question.
• After each element and its subsequent questions have been answered, a total score will be updated automatically at the bottom of the list of questions and in the Summary tab for the evaluation.
• The total score is calculated automatically and provides the facility with a quantitative evaluation of how well it is meeting the regulatory requirements included in the 21 elements. The user may then set an acceptable or "passing" grade for the audit based on the results.
• This audit checklist will serve as an excellent basis for an internal or external audit process.

Save $100 on our Audit Checklist now!

Installation Qualification Template at KymaSTORE

Hi,

I'm excited to say that our Universal Installation Qualification / Operational Qualification (IQ/OQ) Template is now one of our top sellers on our KymaSTORE.



This template provides a universal Installation Qualification/Operational Qualification (IQ/OQ) Protocol template, in a fully editable Microsoft Word document with example text, that can be used to generate IQ, OQ, and IOQ protocols as well as adapted for many other protocols.

It includes all types of data and tests that are expected to be captured to achieve regulatory compliance for FDA, ISO, & EU regulations.

Visit our store and use the coupon code "ITandMarketing" to receive a 10% off discount on any download!

More New Biologics CMOs on CMOLocator!

At Kymanox, we're quite excited about all of the Contract Manufacturing Organizations that are joining our Biologics CMO Search Engine.

Here's a list of the most recently added partners:

AAIPharma Services Corp.

Althea Technologies, Inc

Avecia

Cytovance Biologics, LLC.

Enzon Pharmaceuticals

Eurogentec Biologics

Formatech, Inc.

Goodwin Biotechnology, Inc.

Hyaluron Contract Manufacturing (HCM)

Miltenyi Bioprocess

Novozymes

PacificGMP

Paragon Bioservices, Inc.

Pyramid Laboratories, Inc.

Vivante GMP Solutions, Inc.

CMOLocator (Part III)

I wanted to post an update on the latest Organizations to join our new Biopharma CMO Search Engine:

NEW ACTIVE PARTNERS:

AERAS

Charles River

Eden Biodesign

Florida Biologix

Goodwin Biotechnology, Inc.

Hyaluron Contract Manufacturing (HCM)

Omnia Biologics

Pyramid Laboratories, Inc.

University of Maryland Biotechnology Institute

Thank you to all of the organizations above for helping to grow our search engine.

In addition to our Active partners, we have a number of "CMOLocator Added" partners. These are partners with whom we have worked in the past, and have knowledge of their production lines.

NEW CMOLOCATOR ADDED PARTNERS:

Althea Technologies, Inc.

Avecia Biotechnology Inc.

Avid Bioservices, Inc.

CMC Icos Biologics

Diosynth Biotechnology

DSM

KBI Biopharma

Lonza

Rentschler Biotechnologie

Please visit CMOLocator.com for more information about our Biopharma CMO Listing and Search Engine.