Start with the business function
Scope capture for the teams and conversations involved, whether commercial, operational, or another approved business use.
Pharmaceutical Firms
Capture the business conversation.
Capture pharmaceutical teams’ business conversations across iPhone, Android, and WhatsApp Business and Personal. Build records coverage around the services each team uses.
Discuss Your Capture NeedsDifferent teams. Different messaging services.
iPhone
iMessage · SMS · MMS · RCS
Android
SMS · MMS · RCS
WhatsApp Business
Business app conversations
WhatsApp Personal
Personal app conversations
Choose coverage for the business process in scope.
Connect mobile work with your records program.
Commercial, operational, legal, and regulated workflows may involve different messaging services. FirmScribe’s portfolio covers iMessage, SMS, MMS, RCS, and WhatsApp Business and Personal. Define the business function and required records first, then choose the capture configuration.
Define personal-device boundaries
Use full or selective capture to match your device policy and the work conversations you need to retain.
Connect the records destination
Deliver captured messages into the archive or agreed system supporting your organization’s records workflow.
Start with the kind of record you need.
Business records
Support legal and corporate recordkeeping.
Define the relevant commercial or operational conversations, capture scope, and archive destination under your organization’s policies.
Regulated uses
Evaluate the complete workflow.
Where FDA record requirements apply, quality and regulatory teams assess the intended use, applicable predicate rules, validation needs, and controls. Capture alone does not establish compliance.
The business process determines the evaluation. A message’s use matters more than the fact that it was sent from a phone.
Explore the iMessage capture layer →Make deployment manageable for IT.
Use onboarding and offboarding tools, activity visibility, detailed logging, and proactive alerts to administer capture. Review the configuration with the teams responsible for the intended use.
Questions from your team
Does Part 11 apply to every message at a pharmaceutical company?
No. Applicability depends on the underlying FDA record requirement and how the electronic record is used.
Can we use this in a regulated workflow?
Evaluate the specific intended use, configuration, validation needs, and controls with quality and regulatory teams. Capture alone does not establish that the complete workflow meets its requirements.
Can messages go into our existing archive?
Tell us the destination and use case so we can confirm the integration and delivery configuration.
Requirements and guidance
FDA’s Part 11 guidance ties applicability to electronic records under relevant predicate rules. Determine the requirements for the actual process and assess the complete system accordingly.
FDA: Part 11 scope and applicationLet’s start with your use case.
Bring your teams, device policy, and records destination. We’ll map the capture workflow together.
Discuss Your Capture Needs