Just like most Industries and sectors, the Pharmaceutical market consists of raw materials, manufacturers, Research and Development companies, Marketing and Consumers, yet it is far more regulated and capital-intensive than any other Industry.
What the FDA states?
- Manuel systems have large, inherent operational risks, and are difficult to validate.
- If it isn’t documented, it isn’t done!
- If it wasn’t done using an appropriate process, it wasn’t done correctly.
Asset Guardian securely controls and manages Data Integrity
Data Integrity is fundamental in a pharmaceutical quality system and ensures that medicines are of the required quality. By having a secure data governance approach, you can guarantee that data is complete, consistent and accurate , irrespective of the format in which data is generated, used or retained.
Asset Guardian meets the software management needs of the organisations operating in high value, high risk production environments. Asset Guardian provides solutions across a range of process and manufacturing industries, with a particular focus upon the Pharmaceutical Industry:
• Business Critical Information and Documentation
• Proprietary Software Installations
• Proprietary Software Licenses
• PC/Hardware Build Inventory
• Electronic Workflow Forms (i.e CSV/CAPA) • Change Management
• Electronic Batch Records Management
• User Access Control
• Security and Integrity Management
• IACS software management and Version Control
• Secure access to drive GAMP best practice
Asset Guardian Solutions Limited has in-depth knowledge of the standards and regulation governing many highly compliant Industries, such as Pharmaceuticals. Our customers minimise the risks and costs associated with non-compliance, while great improving the efficiency and integrity in their processes.
