Pharmaceutical & Clinical Document Management and Storage

The industry is highly regulated, as is the processes related to the recording and documentation for the testing, manufacturing and production of drugs. For many organisations information is meticulously recorded in Lab Books, with each page noted as to page number and with a user signature.

Whilst we have carried out scanning of these vital books and provided the information as high quality scanned images of each page, all clients have commissioned IPC to also store the physical books for safety and in case of audit requirements, in the future. With options for retrieval of the books available pharmaceutical companies use IPC’s full range of services.

Pharmaceutical and clinical companies regularly store a variety of physical documents with The IPC Group to comply with regulatory requirements and to maintain accurate records of their operations. These documents include:

1. • Clinical Trial Documents: These include protocols, informed consent forms, trial master files, investigator brochures, and case report forms. These documents are critical for ensuring the proper conduct of clinical trials and for regulatory submissions.

   • Regulatory Submissions: Applications for drug approval, such as New Drug Applications (NDAs) and Biologics License Applications (BLAs), along with supporting documents, are stored. This also includes correspondence with regulatory agencies like the FDA or EMA.

   • Quality Control Records: Documentation related to quality control tests, validation of testing methods, and batch records are crucial for demonstrating compliance with Good Manufacturing Practices (GMP).

   • Standard Operating Procedures (SOPs): These are detailed, written instructions to achieve uniformity in the performance of a specific function. SOPs are vital for training and ensuring consistency in operations.

   • Manufacturing Records: This includes batch manufacturing records, packaging records, and equipment maintenance logs. They are key to tracing the production history of a batch of a pharmaceutical product.

   • Pharmacovigilance Documents: These involve adverse event reports, safety monitoring reports, and risk management plans. They are critical for ongoing monitoring of the safety profile of a drug.

   • Patent and Intellectual Property Documents: Patents, licensing agreements, and other intellectual property-related documents are stored to protect proprietary information and innovations.

   • Auditing and Inspection Reports: Records of internal audits, as well as inspections by regulatory authorities and other third parties, are kept for reference and compliance purposes.

   • Training Records: Documentation of employee training on processes, equipment, and regulations is important for compliance and for maintaining high standards of operation.

   • Research and Development Documentation: Lab notebooks, research reports, and data from pre-clinical studies are essential for tracking the progress of drug development and for future reference.

 

If you would like further details on The IPC Group’s document storage services, please click here or call us on 08081 45 46 47.