Records & Information Management
Records need to be treated as a company asset
Much of the information that Roche employees create or receive in the course of their business are valuable assets for Roche and need to be retained as official records. This is crucial for the protection of Roche’s interests, to fulfil regulatory obligations, and for potential scientific re-use. Records may be in various formats and are made up of data and associated metadata.It is the responsibility of employees to ensure that records are protected from loss or misuse, their integrity is maintained and they can be found and accessed for business purposes and in case of inspections.
Roche’s corporate records management programme (“COREMAP”) defines standards to improve the protection and identification of records throughout the company.
Records belong to Roche and not to an individual. They need to be managed in compliance with internal and external standards and regulations, and be kept for a defined time period. Official records and their required control levels are listed in the Roche Group Records and Information Classification. Convenience records are only of temporary value and will need to be regularly disposed of to avoid risks and costs.
Roche employees need to apply the following principles whenever they create and manage a record:
- think before writing and decide whether it is necessary to create a record;
- be factual, do not make assumptions and avoid misleading and suggestive wording (e.g. in mail or social media postings);
- make sure that the record is in compliance with applicable laws and regulations;
- never create a document for which Roche would not be prepared to take responsibility;
- make sure that there is always a knowledgeable person assigned to the record during
- be mindful of the level of confidentiality by sharing and storing it in a way that the assigned confidentiality can be ensured. Do not share a record with recipients, especially externally, if there is no need for them to have access to it.
Records that reach the end of their defined retention time must be disposed of in line with Roche Records Management procedures and standards, unless there is a need for further scientific use. Records containing personal data or sensitive personal data may not be kept past the required retention time.
Records that relate to any actual or imminent legal proceeding or regulatory investigation are subject to compulsory retention (so-called “legal hold” or “law hold”); Roche employees are not allowed to destroy these records and must retain them until such hold is lifted.