A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specifications, acceptance criteria, reports and approval. Protocol management is a part of document management system in pharmaceutical and life science industries.
Any official procedure or system of rules need to be validated from a base. For our industry, the base is pharma regulatory. Any protocol needs to be compliant before it is validated and approved.
Validation protocol must be written before carrying out a validation activity. Therefore, when an organisation is managing all documents, it is important that each document is synced with other documents like SOP’s, Controlled documents, work instructions and specifications.
Why is digital Protocol Management required?
May it be physical or digital, managing this piece of document is the most crucial part for any business organisation. However, managing it digitally has a few benefits that can be useful to you:
Reduce implementation cost
Reduce implementation time
Increase operational effectiveness and productivity
Efficient inventory management
Improve planning
Enables immediate decision making
Control batch wastage
Reduce loss making activities
Features
Designed and developed to follow cGAMP guidelines
21 CFR Part 11 complaint
Electronic BMR (Batch Management)
Multi location warehouse management
Audit trail
Change control
Access levels
Fully integrated with other systems
Stringent process flow norms
Organisations are moving towards a digital transformation journey and taking the advantage of digitised data to make enhanced decisions and overview all activities in real time. If you are wondering how you can implement this for your organisation, drop us an email at sarjen@sarjen.com or visit www.sarjen.com and get started.
Sarjen is a 25-year legacy brand providing digital and automated solutions for pharma and life science sector. With the rich experience of industry knowledge and advantage of technical exposure, we understand business needs and provide solutions as per organisation requirements.
