Onboarding

The steps

1. Kickoff call. About an hour. We walk through your products, how a batch moves through your plant, who signs what and the paper forms you use today. You leave with a short list of what to send us.
2. Create your company. You sign up and invite us as a member, so we can set things up with you. Getting started on Home shows what's done and what's next.
3. Import your spreadsheets. You send your current lists; we clean them up and load them with the import templates. Every row is checked, and you review the result.
4. Build master manufacturing records. We turn your current batch records into master records: ingredients, steps, weighings, checks and sign-offs. Your QA person reviews and approves each one.
5. Set up floor tablets. Each shared tablet or laptop becomes a station with a one-time setup link. Operators get a starting PIN and sign in with initials and PIN. We check scales, labels and printing on each.
6. Training. Short sessions for office staff, supervisors and operators. Everyone completes the in-app course for their role and supervisors sign off their people: your training record.
7. Practice round. One full batch from start to finish, using the "try it out" round, so everyone sees the whole flow before it counts.
8. Validation and the letter to the FDA. You review the validation documents in Settings > Validation, and mail the one-time letter to the FDA for electronic signatures.
9. Go live. Your first real batches run in BatchFlow. We stay on call during them and check in after the first week.

The letter to the FDA

Before electronic signatures replace handwritten ones, the FDA asks for a one-time letter certifying they are legally binding (21 CFR 11.100(c)). BatchFlow prepares it for you under Settings > Validation.

• It says your company intends all electronic signatures by its people to be the legally binding equivalent of handwritten ones.
• The owner or a senior officer signs it by hand, on your letterhead.
• Once is enough: one company-wide letter covers everyone who signs, now and later. If you already sent one, you don't need another.
• It goes to: U.S. Food and Drug Administration, Electronic Submissions Gateway, 3WFN, Room 7C34, 12225 Wilkins Avenue, Rockville, MD 20852. Check the FDA's page "Letters of Non-Repudiation Agreement" before mailing, and don't use USPS Priority Mail Express.
• Keep a copy in your validation file to show an inspector.

What you'll need to provide

• Item list: raw materials, packaging and finished goods, with units and current stock
• Ingredients lists or formulas for each product
• A blank copy of each current batch record and floor form
• Suppliers and customers (an export from your accounting system works)
• People: names, roles and who supervises whom
• Equipment, including scales and their check weights, and storage locations
• Tablets or laptops for the floor, on your Wi-Fi
• One QA person to review and approve master records
• Time for training: about an hour for office staff, 30 minutes per operator
• The letter to the FDA, signed on your letterhead

Anything particular to your plant comes up on the kickoff call.

Questions

Write to support@usebatchflow.com, or see the plans.