Hitec Laboratories

Compliance success in the Pharmaceutical sector

Hitec Laboratories, the specialist Compliance, Risk & Performance, and Electronic Document Management & Delivery solutions developer have announced that Alliance Pharmaceuticals, a specialist pharmaceutical company based in the UK, are implementing the market leading Policies & Procedures Management solution, CONFORM™.

Alliance Pharmaceuticals owns or shares the rights to 33 branded pharmaceutical products and has a strong track record of acquiring the rights to established niche brands. The cores of Alliances’ activities have been in the UK and the Republic of Ireland. However, recent acquisitions have enabled an International expansion to growing markets such as China.

John Barber, Director of Scientific Affairs & QP Pharmacovigilence, says “The Pharmaceutical industry is heavily regulated and CONFORM™ reduces the risk of damage to reputation as well as ensuring that organisations avoid financial penalties for non-compliance.”

Barber continues, “Regulatory bodies such as MHRA (Medicines and Healthcare products Regulatory Agency), EMEA (European Medicines Agency), FDA (Food & Drug Agency), impact and regulate all Pharmaceuticals Companies who operate internationally. These bodies monitor areas such as GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), GPvP (Good Pharmacovigilance Practice), GLP (Good Laboratory Practice), GDP (Good Distribution Practice). These are all areas that a Quality Manager within a Pharmaceutical Company has responsibility for.”

By providing evidence of Best Practice and Compliance, CONFORM™ gives Managers certainty that Policies, Procedures & Regulations have been received, read and understood by members of staff.

CONFORM™ is a software solution that enables organisations to manage their Policy and Procedure documents in a highly cost-effective way. The software enables the various policy, procedure, and training documents to be accurately version-controlled, and disseminated automatically to the staff who are meant to receive them. Further, the software advises the author, or Department Manager, as to who has read the documents, and even advises on the recipient’s level of understanding. CONFORM™ ensures that organisations can prove their compliance in areas of the business where procedures and policies need to be adhered to.

Les Richardson, Sales Manager at Hitec (Laboratories) Ltd. says, “Traditional methods of policy & procedure distribution such as paper based manuals, corporate intranet and/or email, simply cannot ensure the requirement to prove that these documents have been received, read and understood – and that the knowledge and training has been retained.”