The Validation and Implementation of a Chromatography Data System 1

By: Terry Thompson, Nichola Stevens, Jayne Bradley, Marian Mutch
The Atlas 2000 chromatography data system (CDS), developed and supplied by Thermo LabSystems (Altrincham, UK), was implemented at Covance as an upgrade to the current CDS, Multichrom Version 2.0. Multichrom runs on a VAX minicomputer cluster using VMS as the operating system and, although it has proved a robust and reliable CDS for several years, it was thought necessary to upgrade the software. Multichrom was built using 'old technology' that was not adequate to meet the current and future expectations of Covance, and its validation was considered inadequate to meet modern standards. Also, because of the introduction of the US Food and Drug Administration (FDA) regulation 21 CFR Part 11 for electronic records and electronic signatures in August 1997,1 compliance with this regulation became a priority.
The introduction of a major new system into the company presented logistical challenges - the system needed to be implemented in a compliant manner following software development life cycle (SDLC) principles, whilst ensuring seamless integration into the operational areas to minimize the effect on ongoing projects (Figure 1). To deal with these issues, it was necessary to identify key personnel from across the site, to get high-level commitment to the entire validation process and to plan the validation by implementing in a phased approach by department.

Figure 1: Overview of the software development life cycle.
Phase 1 of the project involved implementation into the Pharmaceutical Analysis Department, which included validation of the major functionality of the application. This phase encompassed the installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). The documentation for the IQ and OQ was produced by the software supplier in conjunction with the company's own Atlas validation team. As Phase 1 of the validation was progressing, the company introduced its own system life cycle, the Covance System Life Cycle, (CSLC). Phase 2 of the project involved the roll-out of the software into the remaining five user departments and was achieved using the CSLC templates. The CSLC was an adaptation of the traditional SDLC, which met the specific requirements of Covance. Phase 2 of the project also served to capture the validation of additional functionality not addressed in Phase 1. Phase 3, which is ongoing at the time of writing this article, is involved with validating the migration of data from Multichrom into Atlas and the formal retirement of the Multichrom system. Life cycle approach Validation, implementation and management of computer systems using SDLC principles has been well documented.2-7 This approach has become standard practice for the validation of computerized systems for use in the pharmaceutical industry. Covance began to implement this life cycle approach with the validation and implementation of the Analyst software (PE Sciex; Applied Biosystems, Foster City, California, USA),7 using QualifyPlus (Version 3), a generic system of documentation specifically designed for the validation of CDSs.8 The project for the qualification and implementation of Atlas was based on the above validation. Figure 2 provides an overview of the overall validation process.

Figure 2: Validation process overview.
Identifying the key players and planning the project The implementation project involved personnel from the vendor working alongside personnel from various departments at the implementing company. These were the user department (Pharmaceutical Analysis), information technology (IT) and quality assurance (QA). The demands of the business meant that it was necessary to have this application installed, validated and running in the live environment to meet tight deadlines but also to have minimal impact upon the progress of current studies. For these reasons it was necessary to ensure that management and all the key players were fully committed to the project and that resources would be available when required to complete the project on schedule. Careful planning was therefore essential and use was made of project plans. The roles and responsibilities of the key personnel are highlighted in Table I. Concept The starting point for all vendor supplied software management projects involves the assessment of the available systems. This process involves the assessment of the application against the user requirements. This may include a vendor audit, which encompasses IT and regulatory requirements. With the advent of 21 CFR Part 11, this became a prerequisite before a final decision could be made.
Requirements gathering and system evaluation For the replacement of Multichrom, three systems were evaluated: Atlas (Thermo LabSystems), Millennium32 (Waters Corporation, Milford, Massachusetts, USA) and Chromeleon (Dionex Corporation, Sunnyvale, California, USA). Supplier assessment questionnaires were sent out to each of the vendors as part of this process. The responses to the supplier assessment questionnaires were retained as part of the SDLC documentation. 

2 comments:

Arpita mohapatra said...

This process involves the assessment of the application against the user requirements. This may include a vendor audit, which encompasses IT and regulatory requirements. With the advent of 21 CFR Part 11, this became a prerequisite before a final decision could be made. more information

sandip said...

Bio-Med and Pharmaceutical Validation can be very simple and straight forward, and then again at times, it can be complex and difficult. A great deal depends on the contents of the company Corporate Quality Manual. This is where all company approved bio-med and pharmaceutical validation regulatory Practices and Procedures must be defined and documented. Failing this being in place, the VMP and VP must document the validation procedures that the company has decided are required. The protocol writers and executers must then follow these instructions.click here