Spera Pharma is a Contract Development Manufacturing Organization (CDMO) conducting both CMC R&D and manufacturing of investigational drugs. Spera Pharma obtains information from customers and conducts business while providing information to customers, so appropriate information management is considered to be of utmost importance. In order to use our service with confidence we have established and comply with the following policies regarding information management.
Spera Pharma will maintain an information management system necessary for the protection of all information assets held and establish appropriate internal rules.
Spera Pharma will assign an information management officer and information managers etc. to accurately grasp the company-wide status of information management and promptly take any necessary measures.
In order to prevent any unauthorized access, destruction, information leakage, or tampering with respect to information assets, Spera Pharma implements fraud measures from an organizational, physical and technical viewpoint, which are continually being reviewed and improved.
Spera Pharma will comply with laws, regulations, norms on information assets used in corporate activities and promises concerning contractual information management made with customers.
Spera Pharma will carry out information management education and training for employees, so that all employees recognize the importance of information management and can carry out business with the necessary knowledge.
Spera Pharma will regularly conduct internal audits of information management in order to verify whether the information management system is functioning effectively, in compliance with laws, regulations, norms and internal rules concerning information management in corporate activities.
When Spera Pharma entrusts the outsourcing to a third party, it will confirm that they have the level of information management that conforms to Spera Pharma’s policies and standards, in the process of reviewing eligibility as a contractor. Also, Spera Pharma will periodically confirm that the information management level of outsourcing parties is properly maintained.
Spera Pharma shall promptly respond to any infringement of laws, regulations, norms related to information management, breach of contract with customers, or accidental information leakage and reduce the effects of any violations or accidents as much as possible.
Date of enactment: September 26, 2018