MAINPAC has introduced the Mainpac Pharma module, a suite of maintenance and asset management functions designed to support the manufacturing of pharmaceutical products.
Influenced by the growing trend towards globalisation, the pharmaceutical industry is subscribing to the benchmark regulations of the US Federal Drug Administration (FDA).
Those regulations (and the Enterprise Resource Planning and computerised maintenance management systems whose processes support the regulations), typically apply to pharmaceutical manufacturers making products for export.
FDA regulations, which to a large degree are mirrored in those of Australia's Therapeutic Goods Administration, require compliance with enhanced security provisions and authentication of changes to records which effect the Gross Manufacturing Process (GMP).
Mainpac product and marketing manager Peter Bates said this meant additional system controls were required when making changes to the planning and scheduling of maintenance and calibration activities.
“In other words, enhanced regulations designed to ensure the consistency of the manufacturing process in the interest of public health and safety.
"Pharma extends the range of benefits that our customers have come to associate with the Mainpac product suite over many years, adding to these benefits to address the challenges of today's pharmaceutical manufacturing industry," Mr Bates said.
In the past, manufacturers had to commit to greater manual processes and information input to achieve compliance with FDA and TGA regulations.
Pharma overcomes the need for the surrounding manual procedures and delivers benefits in three major areas:
* Greater security, meaning better control of user access to the system.
* Authentication of changes to GMP.
* Aaudit trail — online saving of changes to records and no need to manually keep a record of how maintenance is being managed.
Mainpac's Pharma module was developed to underpin its long-standing reputation as the 'industry standard' maintenance system for pharmaceutical companies.
Mainpac users among Australian pharmaceutical manufacturers include Pfizer, Baxter, Sigma, Herron, Pharmacia and Mayne Health. The Therapeutic Goods Administration is also a Mainpac user.
"Development followed extensive consultation and focus groups, not only with individual manufacturers but with consultants to the industry. They defined the requirements of the module which were then engineered into a powerful solution by Mainpac's design and development team," Mr Bates said.
Mainpac Pharma is designed for the .NET environment.