LOCATION: Schering-Plough (contract)
SITUATION:
Schering-Plough needed to convert a large number of documents from paper to digital format while implementing FDA-specific record standards, all within a restricted timeline.
NEEDS DEFINITION:
The accelerated timeline required assembling a team of individuals from other parts of the company who had little knowledge of the types of documents to be converted and no knowledge of the standards to be applied.
SOLUTION DEVELOPMENT:
Standards and Templates Mastery: After completing a comprehensive review of FDA-specific record standards and learning the details of required templates, a complete set of job aids was developed for the technical writing team, addressing:
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Rules for applying standard format conventions
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Grammatical requirements for each form type
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Required and optional field requirements for each form type
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Peer Review checklist criteria and implementation
Team Training and Support:
Activities included:
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Training new editors and writers on best practices in writing and editing
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Working closely with writers to provide feedback and guidance on content improvement
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Examining documents for clarity, coherence, and consistency
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Correcting grammatical, punctuation, and spelling errors while enhancing overall readability
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Ensuring all documents complied with established style guides and FDA formatting requirements
This comprehensive approach enabled the team to complete the document conversion while maintaining full FDA compliance and timeline adherence.