Answer :

Final answer:

In the case of Proteins 'R Us, proper quality management system documentation should be meticulously maintained to support operational processes and demonstrate the company's adherence to quality and safety standards, which is critical for ISO 9001 compliance and important for legal defense in case of litigation.

Explanation:

For a pharmaceutical company like Proteins 'R Us, which is likely to operate under the guidelines of the ISO 9001 quality management system (QMS), maintaining rigorous documentation and record keeping is crucial. This is not only for the purpose of satisfying the requirements of certification but also as legal protection in the event of litigation. For instance, the quality documentation required by ISO 9001 includes various records such as training records, policies, procedures, and calibration records, which collectively demonstrate that the organization adheres to high standards of quality and safety. In the context of potential litigation, these documents provide evidence that the company has been operating correctly and may help to defend against claims of negligence or defective products.

According to ISO 9001:2015 clause 4.4, organizations need to 'maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are carried out as planned'. This means that the duration for which the QMS activity documentation should be retained can vary but should be long enough to ensure that the company can demonstrate the efficacy and safety of its processes at the time the product in question was manufactured. Documented information should be controlled carefully, and the company must define procedures for their approval, updating, identification, retrieval, and disposal.

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