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Take a look at a selection of our recent media coverage:

Stalis launches new web-based solution

11th December 2012

Patient’s current and historical records, sourced across multiple clinical IT systems, can now be accessed via a new web-based solution called CareInform.
Developed by Stalis, a provider of ‘end to end’ data and resource management solutions, it offers users across all health and social care settings a complete long-term view of a patient’s health conditions and treatments based on a single integrated repository.
As pressure to transform NHS patient services continues, CareInform is ideally placed to help local health organisations achieve the Department of Health’s (DH) Quality, Innovation, Productivity and Prevention (QIPP) targets. Plus CareInform can meet the needs of the newly unveiled NHS mandate which advocates ‘that all patients should have an integrated electronic record of their care that can follow them to any part of the NHS or social care system, by 2015’.
Supporting these objectives, the CareInform solution means that information from social, primary and acute care can be intuitively linked and integrated enabling healthcare professionals to access accurate historic and current patient data quickly and easily from any site location, or compatible mobile tablet/phone. By making information more accessible and of better quality, this allows more informed decision-making leading to improved treatment and diagnosis, especially for patients with ongoing health problems.
By facilitating the integration of care, CareInform also has the capability of extending access and involving patients, therefore empowering them to make decisions on their own healthcare, leading to improvements in quality of data, attendance and outcomes.
Developed as a real-time patient-centric system, CareInform can pull information from any type of clinical or administrative system to create a single longitudinal patient record. This again supports another DH initiative, the ‘Information Strategy’, which includes a key ambition to deliver ‘joined up’ care by enabling healthcare providers and commissioners to share information electronically.
By supporting these objectives CareInform can help to minimise gaps and delays in treatment pathways, join up services and improve the patient experience.
Christine Whitehouse, managing director at Stalis said: “We’ve spoken with Clinical Commissioning Groups (CCGs) and discovered they want a way of intelligently linking data from different systems into one easy-to-use place, to save clinical and administrative time, whilst providing better quality of information. And it is by listening that we have developed CareInform to deliver against these needs.  
“A fully informed clinician armed with instant access to a patient record, and a comprehensive view of a patient’s history across other healthcare settings along the care pathway, will be more empowered to make the most appropriate treatment decision. This can only improve health outcomes and lead to a safer, more efficient and effective health service, which CareInform can help to achieve.
“Our approach has always been to improve the quality of information available and, ultimately, helping to improve patient care. With CareInform, users are provided with a standardised overview of the full continuum of care, based on our tried and tested CareXML® platform. This means that our solution has been designed to be easily integrated with established systems eliminating the need to ‘rip and replace’, therefore protecting existing investments.”
The strength of CareInform is based on the fact it is supported by the robust and secure CareXML® platform which has been developed over the past 10 years to provide a well-established Integrated Patient Record (IPR) system. Stalis has been successful in implementing these systems in many trusts including Dudley and Walsall Mental Health Partnership NHS Trust.

Rejected hearts now viable for transplantation after stress echo

6th December 2012

Hearts previously rejected due to donors’ age or other risk factors can now be declared viable for transplantation using pharmacological stress echo, according to research presented at EUROECHO and other Imaging Modalities 2012. The study(1) was presented by Dr Tonino Bombardini from Pisa, Italy.
EUROECHO and other Imaging Modalities 2012 is the annual meeting of the European Association of Cardiovascular Imaging (EACVI),(2) a registered branch of the European Society of Cardiology (ESC).(3) It takes place 5-8 December in Athens, Greece, at the Megaron Athens International Conference Centre.
Heart transplantation is an established procedure in patients with end-stage heart failure but it is limited by a severe donor organ shortage. The average age of organ donors has increased and the donor is frequently a patient who died of a stroke. Every year in Europe a pool of 4,500 hearts for which permission has been granted for heart donation are unused.(4) “Many of these hearts could be used if we could increase confidence that the transplantation would be successful,” said Dr Bombardini, who is scientific coordinator of the Aged Donor Heart Rescue by Stress Echo (ADONHERS) Project.
 
“Currently, the use of hearts from donors = 50 years (of the total transplanted hearts) is just 21% in Europe and 12% in North America,” he added. “But the lengthening of waiting lists for heart transplantation is a significant healthcare emergency and as a consequence, the criteria for acceptance of donor hearts have been expanded to include donors over the age of 55 years.”(5)
Dr Bombardini continued: “Despite the expanded criteria, clinicians are hesitant to use hearts from older donors. The use of stress echocardiography to select hearts ‘too good to die’ may be a possible approach to resolving the mismatch between organ supply and demand.”
During 2005 to 2012, the ADONHERS Project included 66 candidate heart donors who would previously not have been considered due to their age or other risk factors. The average age of candidate donors was 55 years. After a legal declaration of brain death, 47 donors were still considered eligible and underwent dipyridamole (n=44) or dobutamine (n=3) stress echocardiography to look for coronary artery disease or cardiomyopathy abnormalities.
The researchers found 35 hearts without heart disease that were therefore eligible for transplantation. For six of these hearts, a matching recipient could not be found and a cardiac autopsy verified the absence of significant coronary artery disease or cardiomyopathy abnormalities.
The remaining 29 eligible hearts were successfully transplanted in emergency recipients. At 1 month, 26 patients had normal heart structure and function as assessed by angiography, intravascular ultrasound, haemodynamic tests and ventriculography. Three patients had minor single vessel disease.
After a median follow up of 27 months, 26 patients had survived and three had died (from general sepsis, neoplasia and recurrent multiple myeloma).
Dr Bombardini said: “An upward shift of the donor age cut-off limit from the present 55 to 65 years is acceptable if a stress echocardiography screening on the candidate donor heart is normal.”
He added: “Pharmacological stress echo is inexpensive and allows a simultaneous evaluation of inducible ischaemia and contractile reserve of the left ventricle – therefore, it is capable of unmasking prognostically meaningful occult coronary artery disease or cardiomyopathy.”
Dr Bombardini concluded: “Pharmacological stress echo is already an established technique that is used to assess and risk stratify patients with known or suspected coronary artery disease. We have shown that it can also be used to identify hearts suitable for transplantation that would previously have been unused. This requires cardiologists with experience of stress echo and ideally a second opinion from a cardiologist in a core lab (using tele-echocardiography), who can give the green light for donation.”
In addition to the above research, Dr Bombardini’s group will present two further abstracts on this topic at EUROECHO 2012.(6,7)
References
  1. Favourable short-term outcome of transplanted hearts selected from marginal donors by pharmacological stress echocardiography (abstract 50125)
  2. About the European Association of Cardiovascular Imaging (EACVI) The European Association of Cardiovascular Imaging (EACVI) is a registered branch of the ESC. Its aim is to promote excellence in clinical diagnosis, research, technical development and education in cardiovascular ultrasound and other imaging modalities in Europe. It was formerly called the European Association of Echocardiography (EAE).
  3. About the European Society of Cardiology (ESC) The European Society of Cardiology (ESC) represents more than 75,000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the burden of cardiovascular disease in Europe.
  4. Council of Europe, Donation and Transplantation, 2011
  5. The International Society for Heart and Lung Transplantation (ISHLT) guidelines for the care of heart transplant recipients recently recommended that the use of donor hearts > 55 years should only be used if the survival benefit of heart transplantation for a recipient unequivocally exceeds the decrement in early heart transplantation survival due to transplantation of a heart with limited myocardial reserves.
  6. Wait, treat and see: echocardiographic monitoring of brain-dead potential donors with stunned heart (abstract 50250)
  7. Second-opinion stress tele-echocardiography for the Adonhers (aged donor heart rescue by stress echo) project (abstract 50123)

ATP bioluminescence system

5th December 2012

Hygiena International Ltd has further developed their highly successful ATP bioluminescence system to specifically measure bacterial contamination, giving results within a working day or shift.
The development involves their low cost but highly sensitive EnSURE hand-held luminometer, combined with their new versatile MicroSnap Total test. This system enumerates bacteria in raw, cooked and liquid foodstuffs as well as on solid surfaces such that results are available in seven hours or less. The system has been successfully launched at the IAFP (International Association of Food Protection) in Europe and USA as well as the Food Safety Management Conference (Chipping Campden, July 2012).
Established laboratory-based procedures to measure bacterial contamination of foodstuffs can prove to be a lengthy and costly process. The common microbiology test for establishing total bacteria (Total Viable Count , or Aerobic Plate Counts) require laboratory incubation for three days in a Petri dish after which colonies are counted to give results expressed at colony forming units (CFU). The optimum number of bacterial colonies to be counted on an agar plate is 30 –300, thus several decimal dilutions are required to find the detectable range. This means that a lot of time, labour and expense is required for sample preparation and testing. The established convention assumes that one colony is desired from a single bacterium which is a gross over-simplification such that the results obtained are imprecise. Automated systems have been developed to process hundreds of samples but these have a high capital cost and those offering rapid detection systems require measurements to be made over 12 – 18 hours such that results are not available until the next day.
The Hygiena MicroSnap Total bioluminogenic test system has a large dynamic range, being able to detect 10 – 10,000 bacteria without the need for serial dilutions, and every viable bacterium in the sample is measured. Accordingly the result is more precise and sample preparation is simpler, thus saving time and labour. MicroSnap requires simple, low cost equipment and being totally mobile, it can be successfully utilised in small remote locations.
MicroSnap Total can be used to test almost any sample and has been used to measure contamination in a wide variety of food types and on solid surfaces. Contamination levels of <10 cfu/g of ground beef were detected in seven hours whereas >10,000 cfu/g were identified within only 4 hours. Similar results were also obtained for a variety of ready-to-eat foods and good correlations were obtained with the plate count.
For the first time, ATP technology has been modified to be independent of ATP in the sample, such that many specific test applications can be developed, and all of which can be performed on the same, low cost, portable instrument (EnSURE).
This multiple test platform includes specific tests to measure bacterial contamination including specific indicator and pathogenic bacteria. The MicroSnap range includes tests for Total Counts, Coliforms and E. coli. Tests for Listeria species, L. monocytogenes, and Staph. aureus as well as its antibiotic resistant forms are also in development. The ZymoSnap range detects enzymes of industrial importance such as phosphatases for dairy and meat products, proteases, lipases and amylase giving results in minutes. SuperSnap is a high-sensitivity surface hygiene test giving results within 15 seconds, that is used as part of an allergen management program together with a high sensitivity protein test (AllerSnap).

True incidence of disease

Tuesday, 4th December marks the launch of the EUropean, multi-centre, prospective bi-annual point prevalence study of CLostridium difficile Infection in hospitalised patients with Diarrhoea (EUCLID), the largest study of the prevalence of CDI ever conducted in Europe.
For the first time experts will get a clear picture of the true incidence of CDI; a significant cause of morbidity and mortality and a condition that is thought to be widely under-estimated.(2,3)
CDI is the leading cause of infectious diarrhoea in industrialised countries(4) and is estimated to kill one in 50 patients affected.(3) CDI represents a huge economic burden,(5) patients who develop CDI stay in hospital an extra 1-3 weeks(5,6,7) at an estimated additional cost of €7,1475 compared to those without CDI. The incidence and severity of CDI continues to increase.(3,8,9,10,11) The most recent large-scale prevalence study was carried out in Spain in 2008 and looked at the number of CDI cases within the general population at a certain time. Results revealed that two thirds of cases of CDI were either not picked up or were misdiagnosed within the hospital due to low clinical awareness of CDI.(2)
The EUCLID study, which involves 20 European countries and approximately 500 hospitals, aims to identify the underlying incidence of CDI in hospitalised patients with diarrhoea and highlight the extent of under-testing and under-diagnosis per country. The study was initiated and sponsored by Astellas Pharma Europe Ltd and endorsed by the European Society of Clinical Microbiology and Infectious Diseases study group for Clostridium difficile (ESGCD).
“This study represents an important step forward in understanding the true incidence of CDI and will provide us with much needed information about the epidemiology of a debilitating disease in Europe,” said Dr Ed Kuijper, Chairman of the ESCMID study group for Clostridium difficile.
The EUCLID study will be coordinated out of Leeds Teaching Hospitals NHS Trust, UK, under Professor Mark Wilcox, with support from the EUCLID Core Group. The study is funded by Astellas Pharma Europe Ltd. In each of the participating 20 countries, hospitals will submit samples of all un-formed faeces received on a specified day to a national coordinating laboratory where they will be tested for CDI using a standardised protocol. The sampling will be performed at two different time points in the year to reflect seasonal variations in CDI which peaks during the winter months.(12) Data will also be collected on any diagnostic CDI test(s) requested within the hospital for each sample submitted and if so, the test used and the result. These data, along with reported CDI rates from the previous year, will be used to calculate the level of under-recognition and under-diagnosis.
A full report and analysis of the findings will be published at the end of the EUCLID study which is anticipated in mid-2013.
References
  1. Ananthakrishnan AN. Clostridium difficile infection: epidemiology, risk factors and management. Nat Rev Gastroenterol Hepatol. 2011;8:17-26.
  2. Alcala L, et al. The Undiagnosed cases of Clostridium difficile in a whole nation: where is the problem? CMI 2012;18(7):E204-13.
  3. Bauer MP, et al. Clostridium difficile infection in Europe: a hospital-based survey. Lancet. 2011;377:63-73.
  4. Crobach MJ, et al. European Society of Clinical Microbiology and Infectious Diseases (ESCMID): Data review and recommendations for diagnosing Clostridium difficile-infection (CDI). Clinical Microbiology and Infection 2009;15:1053–1066.
  5. Vonberg RP, et al. Costs of nosocomial Clostridium difficile-associated diarrhoea. J Hosp Infect. 2008;70:15–20.
  6. Wilcox MH, et al. Financial burden of hospital-acquired Clostridium difficile infection. J Hosp Infect. 1996;34:23–30.
  7. Dubberke MD, Wertheimer AI. Review of current literature on the economic burden of Clostridium difficile infection. Infect Control Hosp Epidemiol. 2009;30:57-66.
  8. Lyytikäinen O, et al. Hospitalizations and Deaths Associated with Clostridium difficile Infection, Finland, 1996–2004. Emerging Infectious Diseases.2009;15:761–5.
  9. Søes L, et al. The emergence of Clostridium difficile PCR ribotype 027 in Denmark – a possible link with the increased consumption of fluoroquinolones and cephalosporins? Euro Surveillance. 2009;14:19176.
  10. Soler P, Nogareda F, Cano R. Rates of Clostridium difficile infection in patients discharged from Spanish Hospitals, 1997-2005. Infection Control and Hospital Epidemiology. 2008;29:887–9.
  11. Vonberg RP, Schwab F, Gastmeier P. Clostridium difficile in discharged inpatients, Germany. Emerging Infectious Diseases. 2007;13:179–80.
  12. Polgreen PM, et al. A time-series analysis of Clostridium difficile and its seasonal association with influenza. Infect Control Hosp Epidemiol. 2010;31(4):382-7.

Radiometer’s safePICO70 syringes ensure compliance

Radiometer’s safePICO70 arterial blood gas syringes enable safe and simple, single-handed removal of needles, helping to eliminate needle-stick injuries. The safePICO syringes meet the requirements of EU directive 2010/32/EU for the prevention of sharp injuries within hospitals, which came into force in May 2010. This framework agreement calls for increased operator safety when handling blood collection devices – including arterial blood gas syringes, and must be implemented by the 11th of May 2013.
 
To ensure compliance, all blood gas samplers must incorporate safety-engineered protection mechanisms, and hospitals are required to implement procedures for the safe use and disposal of medical sharps; recapping of blood gas sampler needles is no longer permitted. 
Radiometer’s safePICO70 arterial blood gas syringes offer a proven, safe and easy to use way of meeting the specific requirements of the directive, helping to eliminate needle-stick injuries and protect staff from exposure to patient blood. The built-in safety device can be operated with one hand, and allows the simple and safe removal of needles. Once a blood sample has been taken from the patient, the operator just slides the needle shield over the needle and locks it safely into place. The needle, safely contained within the shield, can then be detached and disposed of safely.

PICSO® system show potential to treat severe heart attack patients

4th December 2012

Miracor Medical Systems GmbH has announced  that the Journal of Interventional Cardiology has published the clinical results of 10 patients enrolled in its ‘Prepare PICSO®’ non-randomised safety and feasibility study.
These patients were treated using PICSO® (Pressure-controlled Intermittent Coronary Sinus Occlusion) following primary PCI (percutaneous coronary intervention, or angioplasty) in stable angina patients.
Principal investigator of the study was Prof. Dr. med. Jan Piek and first author was Dr. Tim van de Hoef both at the Academic Medical Center, Amsterdam, Netherlands.
“Results of our Prepare PICSO study show that introduction of the PICSO Impulse catheter can be performed in a timely manner using the femoral venous route, and that PICSO can be performed without the occurrence of adverse events during elective PCI,” said Prof. Piek. “PICSO has the potential to become a significant medical advance: younger patients, 45 to 65 years old, need this technology as a complementary procedure following PCI in STEMI patients in order to avoid additional complications (including heart failure), which occur in about 40% of these patients in spite of a successful PCI.”
“Even after successful coronary angioplasty, suboptimal myocardial reperfusion still occurs in about two out of five STEMI patients, and this unacceptable incidence is notoriously linked to adverse outcomes for patients, such as a death and heart failure,” said Jon H. Hoem, Miracor CEO. “These results of the Prepare PICSO study have laid the foundation for a bigger study of 40 patients, ‘Prepare RAMSES’, which is underway now and expected to demonstrate that PICSO considerably amplifies redistribution of blood into the blood-starved myocardium of severe heart attack patients, even after successful PCI,” added Hoem.
The peer-reviewed Journal of Interventional Cardiology (JIC) is a must-read for interventional cardiologists determined to stay current in diagnosing, investigating, and managing patients with cardiovascular disease.
About PICSO®
Timely myocardial reperfusion using primary percutaneous coronary intervention (PCI) remains the most effective treatment for limiting infarct size, reducing left ventricular remodelling, and improving clinical outcomes following ST-segment elevation myocardial infarction (STEMI). Despite optimum primary PCI, mortality and morbidity following a STEMI event remains sizeable. Clearly, primary PCI alone is not enough to eliminate the risk for future cardiovascular events. Miracor’s Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO®) Impulse System offers a new and innovative approach to reduce myocardial injury and to revitalise ischaemic myocardium. Initial clinical results show positive effects on MACE, restenosis rates, and long-term event-free survival. The PICSO® system consists of the Miracor PICSO® Impulse Console and the disposable, single-use Miracor PICSO® Impulse Catheter.

Olympus THUNDERBEAT and VISERA ELITE showcased

3rd December 2012

Olympus has showcased the THUNDERBEAT – the world’s only surgical energy device which integrates ultrasonic and bipolar energy in a single instrument – and VISERA ELITE, the latest generation High Definition camera system, during a day of surgical procedures screened live to assembled eminent surgeons attending the Association of Laparoscopic Surgeons (ALS) Annual Scientific Meeting.
THUNDERBEAT and VISERA ELITE were successfully used, together with ENDOEYE video laparoscopes, during eight minimally invasive surgical procedures conducted at Bon Secours hospital in Cork, Ireland on 29 November.
The surgeries included a gastric bypass, splenectomy, incisional and TEP hernia repairs, nissen fundoplication, and anterior colonic resection. Transmitted live by satellite, multiple procedures were visible simultaneously and allowed for interaction between surgeons, theatre staff, session moderators and the audience.
This year’s ALS Annual Scientific Meeting – hailed the ‘Rise of the Machines’ – showcased a range of leading technologies and techniques that are revolutionising laparoscopic surgery and shaping its future. Olympus, already known as a market leader in endoscopic imaging equipment is now also becoming a leading force in the surgical energy market. Olympus’ newest innovation, THUNDERBEAT is a unique and versatile energy device that increases the efficiency of surgery by delivering the fastest cutting speed amongst comparable energy devices.
Its integration of bipolar and ultrasonic energies also make it capable of sealing blood vessels of up to 7mm diameter. The VISERA ELITE imaging platform provided exceptional Image quality and demonstrated perfectly the benefits of the fog free image quality provided by the integrated lens heating technology built into the latest generation of EndoEYEs.
Simona Esposito, Head Of Surgical Energy at Olympus said: “The THUNDERBEAT provides best-in-class performance and improves the efficiency of surgical procedures – and we are delighted to have demonstrated its strengths at the premier meeting for laparoscopic surgeons. The ALS annual meeting is a demonstration of the sophistication of procedures which may be carried out using minimally invasive techniques. Due to the continued global increase in colorectal cancer and obesity there will be a greater need for procedures conducted via a minimally invasive approach, and THUNDERBEAT is an exceptional device that is well placed to meet this demand.”
Colm O’Boyle, Consultant General, Laparoscopic and Bariatric Surgeon at Bon Secours Hospital, commented: “The live surgeries were a great success and enabled an audience of leading laparoscopic surgeons to witness and discuss the procedures and technology with their peers. Our event this year celebrated the rise of new technologies in transforming surgical procedures. Technology such as the THUNDERBEAT is already having a positive impact on the theatres using it, and has the potential to make a significant difference to many more.”

European Commission focuses on ‘lessons learnt’ from Paediatric Legislation

Stakeholders ranging from industry to clinicians have had an opportunity to voice their opinions on the Paediatric Regulation in the European Commission’s public consultation that ended on 28 November. It was therefore timely that the next day, the ‘Annual European Medicines Agency Review of the Year and Outlook for 2013’, a meeting organised with TOPRA, included an update on this very subject. 
The Commission’s Florian Schmidt (Unit D5, Medicinal products – authorisations, EMA, DG SANCO) told delegates he was pleased that 35-40 respondents representing ‘a broad scope of customers’ had sent responses to the consultation, the results of which will feed into a report mandated by the regulation. The report is due to be presented to the European Parliament and the Council next year and will focus on ‘lessons learnt’ in the first five years since the Paediatric Regulation’s implementation.
Delegates were keen to know whether the report would also make recommendations for amending the legislation, but Mr Schmidt said that level of detail would be included in a second, more comprehensive report to be released in 2017. “We need some time to really get sound data on the effects of the Paediatric Regulation due to the long development cycles involved,” he explained. The later report will address issues such as the economic impact of the rewards and incentives under the regulation.
Paediatric Committee Chair Daniel Brasseur suggested that pressing issues such as the continued off-label prescribing of paediatric medicines should be addressed within the current legal framework, rather than waiting several years for this to be addressed in the second report. Mr Florian made no promises but responded that the possibility ‘was not excluded’.
In the meantime, the mid-term review, which will include a detailed inventory of all medicinal products authorised for paediatric use since the regulation’s entry into force in 2007, is expected in spring or summer 2013. The benchmarks for the report are the key objectives of the regulation, namely ensuring: high-quality research; the majority of medicines used by children are authorised for such use; and the availability of high-quality information about medicines used in children.
It will address the main themes laid out in the public consultation, which builds on the EMA’s five-year report to the Commission published in July this year. The themes include the regulation’s impact, the PUMA (Paediatric Use Marketing Authorisation), clinical trials in children, receptiveness of healthcare professionals, off-label use and burden.
Emma Du Four, Abbott’s Senior Director Regulatory Policy & Intelligence, provided an industry perspective based on highlights from EFPIA’s response to the consultation. She said that although the Paediatric Regulation has become an integral part of drug development plans, there is a need for changes, some of which could be made within the current framework. For example, a greater opportunity for paediatric dialogue prior to filing PIPs (Paediatric Investigation Plans) would support smoother assessment of the PIPs that follow.
Furthermore, she said that for new compounds the limited data set at this early stage of development (ie, end of Phase I, when PIPs have to be submitted) must be recognised. She also expressed industry’s concern about the lack of a process for inactivating a PIP, causing legal uncertainty. “It is not clear what a company’s obligations are if it stops developing a compound”, she said.

150 years of Bayer

The Bayer Group will be celebrating its 150th anniversary in 2013 with numerous events around the world.
“Bayer can look back on a long and highly successful history as an inventor company,” explains CEO Dr. Marijn Dekkers. “What started as a small but innovative dyestuffs factory in the Barmen district of Wuppertal is now a global enterprise with more than 110,000 employees. In the past 150 years, Bayer inventions have time and again helped improve people’s quality of life. This great tradition is also our commitment to the future – entirely in line with our mission of Bayer: Science For A Better Life.” 
To mark the anniversary, Bayer is planning a series of events and projects worldwide throughout the coming year. These will focus on the company’s employees and their families – but neighbours, customers, partners and the scientific community are also to be included in the celebrations.
“Bayer products have become indispensable to our lives,” says Dekkers. One example is the pain reliever Aspirin™, which came on the market in 1899 and remains one of Bayer’s top products to this day. Over the decades, Bayer’s researchers have developed pioneering active substances to treat infectious, tropical and cardiovascular diseases, for example. Today, pharmaceuticals research at Bayer HealthCare concentrates mainly on the fields of cardiology and haematology, oncology, women’s healthcare and diagnostic imaging.

PRISYM ID announces new validated pharmaceutical software

29th November 2012

PRISYM ID, leading provider of turn-key labelling solutions for organisations that need integrated printing solutions, today announced the launch of PRISYM Pharmaceutical V.6. 
Created to be fully compatible with Windows 7 and with a new Graphical User Interface (GUI) to enhance the user experience, PRISYM Pharmaceutical is delivered with full lifecycle documentation based on the GAMP V (Good Automated Manufacturing Practice) model, which will enable smaller pharmaceutical organisations to ensure regulatory compliance whilst saving time and resource throughout the label production process.
Mick Daw, CEO, PRISYM ID, comments, “The pharmaceutical industry is subject to strict international and regional regulations that manufacturers and distributors must meet in order to supply medical products safely, effectively and securely. Following labelling best practices and lifecycle documentation processes is a big part of the compliance process, and as such requires a significant amount of in-house time and resource.”
He continues, “Use of IT as part of the design, review, and print processes is now common place and in order to meet country specific compliance requirements relating to computer system validation, companies are investing significant additional resources to produce validation documents for these processes.”
PRISYM Pharmaceutical is a fully validated, fully featured, easy-to-use package for designing label templates, creating barcodes and printing labels in-house. With inbuilt security, it allows only authorised users to create, edit or print labels as well as monitor their activity.
The application allows users to manage and verify variable data such as product codes and descriptions, barcode pictures, logos and images, as well as multiple languages in one template, to mitigate the need for creating multiple designs for similar product labels.
It also provides easy connectivity with ERP and MRP systems to help integrate the labelling function with the rest of the business process and additionally allows users to group labels into production batches to send to one or more printers to reduce time taken to print.
PRISYM Pharmaceutical has been designed based on the company’s 30 year experience in the labelling and auto-identification market. Combined with the PRISYM ID’s team’s specialist knowledge in the medical device and pharmaceutical sectors, the solution is built to address the specific requirements of the pharmaceutical label design and printing process.
Mick Daw concludes, “Today’s life sciences organisations are subject to a vast range of regulatory requirements, which are ultimately in place to ensure patient safety. However, it is critical that compliance is ensured without adversely affecting the business’s productivity. PRISYM ID’s label lifecycle management solutions are designed to help guarantee compliance whilst optimising the production process to ensure business efficiency.”