Ensuring the accuracy and consistency of laboratory data so that it complies with regulations like FDA 21 CFR Part 11, GLP & GMP, is a challenge for many organisations. When using a paper-based system, development, version control, approval and distribution of SOPs and worksheets are open to errors, and manual data searching/documentation is extremely time consuming.
When working in an on-site digital environment, security is a great issue, as healthcare and pharmaceutical databases are increasingly subjected to cyberattacks. Moving to the cloud is a great solution, as this not only means that the provider is responsible for security, but also allows for the recovery of files.
The cloud also provides the ability to scale up easily, removing the ceiling imposed by on-site storage. Lastly, it supports data-intense research and development.
Introducing the correct electronic system reduces the burden of complying with the applicable regulations, prevents the reporting of invalid data, and makes better use of laboratory resources.
Author-e pharma solution
The Author-e Pharma solution is an Electronic Lab Notebook and Collaboration Tool for regulated laboratory environments. It serves as a single platform for the management of all quality-related documents and the collection of both structured and unstructured data. Hence, the Author-e Pharma solution can be used in both QA/QC and R&D laboratories.
For QA/QC laboratories the Author-e Pharma solution migrates all existing documents such as SOPs and worksheets into a controlled electronic environment. Using workflows ensures the correct procedures are followed to create, maintain and release procedural documents and worksheets.
For R&D laboratories the Author-e Pharma solution offers a collaboration tool that simplifies the collecting and sharing of experimental data while securing the intellectual property rights.
To comply with regulations related to FDA 21 Part 11 and GLP/GMP, the Author-e Pharma solution includes functions such as audit trail, change control, and e-signature.
Create, review and approve documents. Using workflows and tasks, insights into the progress of e-learning documents and modules can be gained through the notification centre.
Multi-channel publications. E-learning documents and modules can be published to multiple formats, such as Word, PDF, e-Pub, HTML and XML. This ensures that any organisational requirements regarding publications can be met.
Central layout management. Templates and centralised standardisation of fonts, font size, captions, text alignment and spacing ensure that all your documents are consistent with your corporate identity and organisational standards. Forms can be used to standardise data input.
Reusability of content. Sections and documents can be embedded in other documents. This enables modifications to documents to be reflected in all documents that use them, eliminating double maintenance, copy-pasting and confusion about which version is the latest.
Simultaneous writing. Authors can work on the same document at the same time. This eliminates the need to lock documents as is usual in other DMS environments, thus increasing efficiency.
Version control. All previous versions of documents and files are retained, and can be restored if necessary. This is absolutely necessary to comply with norms and legislation, and allows you to look back at documents that were effective in the past.
User access management. Roles and rights can be defined not only at the document level, but also at the section level. These rights are automatically assigned to sub-sections. This allows enforcement of refined access policies.
Digital signatures. Workflows can be coupled with digitally signing off tasks. This, combined with version control, ensures traceability of actions, as well as accountability.