 |
|
|
|
The guide-lines laid out in Good Automated Manufacturing Practices (GAMP) recognizes automated systems in a broad form, including Automated System Validation, manufacturing equipment, control systems, automated laboratory systems, manufacturing execution systems and computers running laboratory or database systems. The automated system generally consists of the hardware, software and network components, together with the controlled functions and associated documentation.
|
Computer Validation Master Plan
$85.00
£43.01
10001301
The Computer Validation Master Plan, is the starting point for validation, and hence the most important validation document. It improves validation efficiency greatly by forcing all concerned to document, review, and discuss, the proposed methods and allotted responsibilities. It is an expected document with the FDA, and a mandated document with the EU.
While in the past computer validation was more focused on functions of single user computer systems, recently the focus has progressed into network infrastructure, networked systems and on security, authenticity and integrity of data acquired and evaluated by computer systems.
However never forget that a piece of equipment is purchased and used, for a purpose, and that purpose is set out in the purchaser’s User Requirements Specification (URS). Therefore the first and foremost requirement for any piece of equipment, is the verification that it satisfies the requirements specified in this URS.
|
CSV Installation Qualification
$85.00
£43.01
10001302
Installation Qualification (IQ) is an important step in the overall validation and qualification process for software and computer systems. Our protocol leads you through the detailed requirements. GAMP 4, is used as a general guide, however there are some areas where it is better to stick with the FDA interpretations.
Validation Online has extensive validation experience, where we know that there is a regulatory sensitive area we make absolutely certain that our documentation is clear, concise and supplies the information the regulators are anticipating. These protocols have evolved over 15 years use in the pharmaceutical and allied industries.
|
CSV Operational Qualification.
$85.00
£43.01
10001303
Operational Qualification (OQ) is an important step in the overall validation and qualification process for software and computer systems. Our protocol leads you through the detailed requirements, progressively and simply. GAMP 4, is used as a general guide, however there are some areas where we find it preferable to stick with the FDA interpretations.
Validation Online has extensive validation experience, where we have found over the years, on the regulatory debriefs, that there are certain presentations that they prefer, we have always been quick to comply. Just as with the IQ, this OQ has evolved over 15 years and countless regulatory reviews.
|
|
|
