BUSINESS TRANSFORMATION THROUGH BATCH RECORD ENGINEERING
404-775-1210BATCH RECORD IMPROVEMENT
Partnering with the Life Science Industry
info@shilay.com
SERVICES INCLUDE:
- Project Management
- Process improvements
- Technical Writing
- Authoring Training
- Improved Review and Release Techniques
- Implementation Support for Batch Records, SOPs, Log Books and Test Methods
About Shilay - a Professional Document Engineering Company assisting Life Sciences with continuous improvement initiatives by sharing best practices and reducing documentation complexity. Working collaboratively with our clients, Shilay is always finding the correct balance between the business requirements and the regulatory requirements. Shilay's approach combines and consolidates disparate data collection forms and attachments into a professionally written contiguous (lot) record. Placing activities at the point of use and exposing critical process parameters; redesigned batch records are more prepared for Electronic Batch Records (EBR).
We not only author documents, but we help train operators/reviewers and implement the new records. Post implementation, we help measure success with metrics implementing positive changes that ensure compliance and operational effectiveness. We ensure that our client Manufacturing and Quality Systems are not only compliant, but in control and sustained with established Rules.
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