Whether it’s the FDA, Department of Health or GMP, meeting government and industry regulations is more important than ever for Pharmaceutical companies.
Regulations are there to ensure the safe and controlled running of the industry, but can often end up becoming a daunting task for mid-sized enterprises.
Compliance is business-critical and companies operating in the Pharmaceutical industry must ensure:
- Full audit trails with user, time and date references
- Signatures to authorise changes, with reason codes and verification
- Robust user security to safeguard against unauthorized use
Many of the government bodies mentioned above acknowledge that technically advanced software solutions can help companies to manage compliance. Sage EM’s level of detail and extensive user controls are especially suited to this level of industrial scrutiny.
Through Sage EM pharmaceutical companies will be equipped with the tools to demonstrate compliance, including:
- Detailed and historical audit trails. This is standard functionality in Sage EM and includes user name, date, time, previous data, new data and the reason for the change.
- Electronic signature framework. This includes tables, programs, actions and objects to store, configure and collect unique e-signatures, which are permanently linked to the object and cannot be modified or copied.
- Document signatures. Documents requiring handwritten signatures, such as Certificates of Analysis or Technical Sheets, are generated with an image linked to the specific document. The image plate is controlled and linked to the user profile.
- Validation workflows. These can be customised depending on the company but can be set up to, for example, not allow release of a drug into stock until the QP has had final, password controlled, sign off.
- Security features. Several security standards safeguard against unauthorized use, including automatic logoff after a period of inactivity, auto logout after too many failed logon attempts and logging of all user activity. Functional access control can also be tailored and/ or limited to specific fields that may contain sensitive information.
Adhering to regulations not only provides companies with the relevant licenses to continue to trade but also sees reductions in system vulnerability, lower compliance-driven costs and shorter validation times. Through a comprehensive solution designed for the Pharmaceutical industry, such as Sage EM, companies can take the pain out of compliance as well as ensuring their overall operational efficiencies.
Find out more: