 |
 |
 |
 |
 |
     |
 |
case study HFL rises to the validation challenge with help from Scimcon HFL, Scimcon and validation For a laboratory operating within the sports testing and pharmaceutical industries the validation of information systems is crucial to meeting regulatory requirements and retaining valuable accreditation. To secure accreditation from the United Kingdom Accreditation Services (UKAS) to the ISO 17025 standard and to be compliant with Good Laboratory Practice (GLP) standards, it is essential that labs have new information systems validated. This means that products must be shown to have been thoroughly acceptance tested before use and remain compliant in use to ensure they match the needs of lab and business users, as well as meeting regulatory requirements. Validation is a complex task that must adhere to lengthy, complicated guidelines demanding thorough knowledge and experience of the workings of a lab. HFL is a company with many years experience offering contract laboratory services in a regulated environment and, recognising the level of expertise required to undertake effective and efficient validation, the company has repeatedly called upon Scimcon, the scientific information management consultancy, to undertake its validation work. Over the past four years, Scimcon personnel have been involved in fifteen validation programs for HFL, including document management systems, network storage, analytical instrumentation systems and laboratory information management systems (LIMS). IT, IS and the need for efficiency HFL, which specialises in pharmaceutical contract research and drugs screening, for equine and canine sports, recognises its reliance on complex information systems, particularly its LIMS, which manages all of the information held in the lab. It reviews its IT and information systems on a regular basis, to optimise performance and processes. The LIMS is upgraded on an regular basis, following focus groups with users (information systems user group) and business managers to assess its performance and discuss where functionality and use-ability could be improved. Because information system upgrades happen regularly, and to ensure it benefits from new systems as quickly as possible, HFL needs its validation processes to be as streamlined as possible. Steve Maynard, Operations Director at HFL, explains: "Validation is a non-negotiable requirement that we want to manage as efficiently as possible. We know Scimcon has real-life lab experience and has a successful track record in providing consultancy and other validation expertise, so we are happy to repeatedly use their services. Other companies providing validation simply can't offer the level of experience and relevant expertise that Scimcon has." Steve Maynard continues: "There are complicated guidelines that have to be taken into account when undertaking a validation. Because of its track record, we can trust that Scimcon will streamline the process as far as possible without compromising quality. It carries out all of the work that needs to be done without wasting time and money with superfluous activity." LIMS validation: Spring 2002 One recent example of Scimcon's work for HFL is a LIMS validation project completed in spring 2002. Towards the end of 2001, HFL planned a LIMS upgrade with configuration changes to meet changing user and business requirements. Following this, Scimcon and HFL personnel jointly undertook the validation process for the LIMS. The first stage was to put together a validation plan advising which tests are crucial and which are not. Scimcon also developed a critical test path, which provides details of the order and way in which tests need to be undertaken, based on the information flow in the lab. Scimcon then managed the testing process, overseeing the tests, which were carried out by HFL's own personnel who use the system on a daily basis. Once all the tests were completed, Scimcon prepared , Scimcon prepared a validation report that summarised the results and provided formal evidence of the process and the outcome. This report was submitted to HFL's managers and can also be used by internal or external auditors of the company Quality System. Steve Maynard again: "The key benefits are clear: not only do we have the necessary validation report to show that HFL's LIMS meets the stringent regulatory requirements upon us, but we are guaranteed that this complicated and time-consuming process has been carried out as efficiently and professionally as possible." Making the grade Through its crucial involvement in validations like the recent LIMS upgrade, Scimcon has played a valuable role in enabling HFL to meet UKAS and other regulatory standards over the past few years. In addition to GLP and ISO 17025, HFL has successfully met the requirements of numerous audits undertaken by pharmaceutical vendors looking to work with the company. Steve Maynard concludes: "Scimcon personnel have been central to our validation success, and we believe that they have been able to do such a good job because of their understanding of the business and scientific pressures we face as well as the technical processes of the lab. In the work that it's undertaken, Scimcon has been able to bridge the gap between IT and the needs of the business as well as the lab, to validate systems quickly and effectively, to meet the requirements of HFL and the market in which we operate." |
|
 |
|
||||||||||||
| Scimcon Limited, Registered in Cardiff No 4844956, Registered Office: 57 London Road, High Wycombe, Bucks, HP11 1BS | |||||||||||||||||
