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Like all businesses, many pharmaceutical companies are planning to gain and maintain a competitive advantage through information automation in research, manufacturing and distribution. Pharmaceutical companies are however tightly regulated, and are required to validate processes, which could have an impact on product quality. Validation is defined by the Food and Drug Administration (FDA) in the United States as:

"Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes".
FDA Guidelines on General Principles of Process Validation, May 1987.

These principles are also applied to computer systems meaning that the importance of correctly documenting all aspects of a computer system implementation cannot be overstressed.  The “documented evidence” as required by the FDA is normally produced by performing rigorous tests of the proposed system which will provide “the high level of assurance” required.

Historically, the FDA has been happy with the level of documentation available to their inspectors indicating that processes were compliant with all relevant guidelines. The whole purpose of automating a process however, is to streamline operations and achieve improvements which obviously lead to savings, and or competitive advantage. In order to enable Pharmaceutical companies to take advantage of new software packages and implement new processes which were delivering significant productivity improvements to non regulated manufacturing industries, the agency issued guidelines to it’s inspectors in 1985, on how to inspect computerised systems, which subsequently became known as the “Blue Book.” In order to interpret these regulations, the agency also issued a number of Compliance Policy Guidelines (CPGs), which helped industry interpret the relevant regulatory requirements.

Some computer software and integrated systems suppliers have made considerable progress in accommodating heavily regulated operations. Available software technology is now applicable, stable, and trustworthy enough to justify the investment required for its implementation in the pharmaceutical industry.
The Food and Drug Administration announced in 1995, that it proposed to issue regulations to regulate the utilisation of electronic records and electronic signatures in Pharmaceutical and medical Device Companies. This was to become 21 CFR Part11. When the agency first announced it’s intentions, it began an advance notification of proposed rule making or “ANPRM” process. This process is designed to enable interested parties make submissions to the agency prior to the regulation becoming law. Our technical director, Jeff McBride made a number of submissions which the agency took on board during this process. The rule became law in August 1997, and since that date, the agency has accepted electronic records and signatures as being the equivalent of manual documents. Because of this, many of our customers have decided to implement new software packages, including Enterprise Resource and Planning (ERP) systems, Laboratory Information Management Systems, (LIMS) Electronic Document Management Systems, (EDMS) and others. Because of KE Consulting Groups’ experience in software validation since our foundation in 1997, we have actively participated in many successful implementations which have subsequently been audited by the FDA, and the IMB. (Irish Medicines Board)

In 1994, the Pharmaceutical Industry in the UK came together under the umbrella of the Pharmaceutical Industry Computer Systems Validation Forum (PICSVF), and laid down guidelines for suppliers of computer systems, as to what the Pharmaceutical Industry required of its’ vendors in order to take advantage of new technologies while at the same time maintaining compliance. Diarmuid Cahalane and Jeff McBride, who co-founded KE Consulting Group maintained contact with a number of key members of this forum including David Selby of Selby Hope International, Sion Wynn, then of Activa Systems, and Annis Bratt of Smithkline Beecham. When the PICSVF subsequently changed its name to the Good Automated Manufacturing Process (GAMP) forum, the guidelines were re-issued as “The GAMP Guidelines.” At the International Society of Pharmaceutical Engineering (ISPE) Conference in Orlando Florida, in 1997, KE Consulting Group exhibited it’s novel “Business Process” approach to validation and regulatory consulting. At this same conference the GAMP guidelines were commended to the FDA, and an embryonic “GAMP of The Americas Forum” was born.
 
Because of our wide knowledge of the industry, and our unrivalled experience with customers involved in large-scale implementation projects, we believe that we can offer the skills necessary to act as a bridge between regulators and industry during the implementation of large-scale systems.
                                                                                               
Our customers are the key to our ongoing success, and now include the following major names:

-  Pfizer

-  Glaxo Smithkline

-  Wyeth

-  Schering Plough USA
(Global Professional Services Agreement)

-  Helsinn

-  Johnson & Johnson

-  Genzyme

-  Achileon

-  Elan

-  Merck USA
(Global Professional Services Agreement)