SOPs and templates for computer system validation
Ready-to-adapt documents from a working validation consultant. Buy a pack once, with no subscription. Every file is a Word or Excel document you edit to fit your own quality system.
Choose your pack
The Store is being set up. Please check back shortly.
All prices are one payment. No VAT charged.
What is in each pack
Not ready to buy? Take a free sample
Subscribe to the newsletter and we send you the Handover Checklist, free.
Packs or membership?
Membership includes every document in the Store, and keeps them up to date.
| Pack or bundle | Membership | |
|---|---|---|
| SOPs and templates | The pack you buy | The full library |
| Updates when documents are improved | No. You keep the version you bought | Yes, as they are released |
| CSV 101 course (15 modules, quizzes, certificate) | No | Yes |
| Course manual | No | Yes |
| Articles, Regulatory Watch, newsletter | No | Yes |
| Ask Iain | No | Yes |
| Price | One payment | From US$75 a year (founding rate while places last), US$149 standard |
Buy a pack or the bundle and join as a member within 30 days, and we take what you paid off your first year, up to half of the first-year price.
Licence
- One licence per company, for internal use.
- No resale, sharing outside your company or redistribution.
- Each file is stamped with your name and your company.
Full terms are in our Terms.
Before you buy
- Files are templates, not finished validation. Adapt them to your own quality system, systems and risk assessments. Using them does not guarantee compliance or an inspection outcome.
- Digital download. You get access straight after payment. By buying, you agree the download starts immediately and you give up the 14-day right to cancel that applies to most online purchases. You tick a box to confirm this at checkout.
- You need an account so your downloads are kept in My purchases. Download links last 14 days and work up to 5 times; you can request more from your account if needed.
- File types. SOPs are Word (.docx). Templates are Word (.docx) and Excel (.xlsx).
Questions
- Can I edit the documents?
- Yes. They are Word and Excel files made to be adapted.
- Do the documents cover Part 11 and Annex 11?
- The pack includes an electronic records and signatures SOP and policy, a Part 11 and Annex 11 applicability assessment and a compliance checklist. They are starting points for your own assessment.
- Will I get updates?
- Pack and bundle buyers keep the version they bought. Updates are a membership benefit.
- Can my colleagues use them?
- Yes, within your company. The licence is one company, internal use.
- What if I want the course too?
- See the CSV 101 course for the course on its own, or membership for everything.