Life science companies deal with tons of data; this data could be related to processes (manufacturing, process controls, equipment, administrative, financial, legal, medical), product (physical attributes, study reports, analytical documents, batch records), regulatory submission documents and other relevant quality documentation.
While this data is crucial to be stored and retained in paper or electronic form, Companies must have an efficient system that maintains such documentation and records. This is especially important for compliance with quality and regulatory standards. Some specific examples of necessary project documentation for life science companies include:
- Protocols and standard operating procedures (SOPs): These documents outline the procedures and processes that should be followed for critical activities such as laboratory and research work, clinical trials, and manufacturing. Regulatory agencies often require them as part of the approval process for drugs and medical devices. Companies can establish an electronic document management system that can track such procedures’, generation, modification, and approval Study reports and data: Life science companies must document the results of their research and development activities, including regulatory-related data from pre-clinical and clinical trials and laboratory experiments. Regulatory agencies often require these documents as part of the approval process for drugs and medical devices. Having such documents in place helps companies keep track of the progress of their product development, any changes made in the process or to the product, and registration and approval.
- Quality management records: Life science companies must maintain records of their quality project management activities, such as calibration and maintenance of equipment and training records of employees. Maintaining such quality documentation helps companies keep track of all change controls, deviations, and non-conformances related to product and quality-related processes. Regulatory agencies also use these documents to check if companies comply with GMP and other related standards during inspections and audits.
- Audit trails: Life science companies must maintain accurate records of all changes made to project documentation, including who made the change and when the change was made and executed. Keeping an audit trail is essential for companies to maintain the integrity of the data for quality and regulatory compliance.
- Archiving: Life science companies must keep records for a certain amount of time, even after the end of the project, as regulatory agencies may require access to these records during inspections and audits.
- Electronic Document Management Systems (EDMS): Many life science companies use EDMS to store, manage, and track project documentation. Having an EDMS has a lot of benefits, such as easy access and retrieval, cloud-based document changes, tracking all changes, maintaining an audit trail, document version control, and archiving the documents.
While maintaining project documents is essential, not having a good project documentation system can lead to several disadvantages for life science companies, including:
- Compliance issues: Life science companies are subject to strict regulations. Most regulated products are meant for human use and must be controlled in all aspects, impacting product quality, safety, and efficacy. Failure to maintain proper documentation can result in non-compliance and potential penalties such as Warning Letters, 483s, suspension, or withdrawal of products from the market.
- Poor quality control: Without proper documentation, it can be difficult to ensure that products and processes meet quality standards or track changes to the product and related processes.
- Difficulty in reproducibility: Without proper documentation, it can be difficult for other researchers or teams to reproduce experiments, tests, or processes. This can slow progress, impede collaboration, and cause process variation that could impact product quality. This can also affect making and replicating planned changes to the product or processes as per change controls, deviations, or non-conformances. Not having a centralized documentation system can also cause all affected employees not to have access to critical data required to make changes or revisions.
- Inefficient use of resources: Not having a good project documentation system can lead to wasted time and resources as team members attempt to recreate or redo work that has already been done.
- Difficulty in tracking progress: Without proper documentation, it can be challenging to track the progress of a project and identify issues or areas that need improvement. It can also lead to not having a trail of all the changes made to a product or process. Such data are usually required during Regulatory agency inspections or audits and are crucial in determining a company’s continued compliance with quality standards.
Overall, maintaining accurate and complete project documentation is crucial for life science companies to ensure regulatory compliance, maintain high standards of quality and safety of the product, and demonstrate the integrity of their data, documents, and processes to regulatory agencies.
PSC software offers many electronic quality management solutions (eQMS), such as ACE and ACE Essentials, that can help your company manage all kinds of project documentation records and help you ensure all your documentation complies with relevant quality and documentation standards and regulations.
PSC also supports developing quality-compliant processes such as cleaning, validation processes, writing SOPs, and other documents such as Batch Records, manufacturing protocols, and regulatory submission documents, which are an integral part of a good eQMS.
PSC also has the expertise to support processes such as change control, deviations, and non-conformances and can also perform audits, risk assessments, and gap assessments to identify areas of improvement before inspections by Agencies. This can help your company ensure compliance is observed in all aspects of the system.
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