Pharmaceutical Computer Systems Validation
Delivery estimate
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Delivery estimate
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Pharmaceutical Computer Systems Validation
Description
Computerized systems play a fundamental role in the development, manufacture and supply of medical treatments. This is the third and thoroughly updated edition of the best-selling book dealing with validation, compliance and software in the pharmaceutical, healthcare and medical device industries. The first volume provides a comprehensive walk-through of lifecycle and development methodologies bringing together technological advances, latest regulatory requirements, inspection findings, and compliance strategies. New chapters have been added on agile development methodologies, data integrity, artificial intelligence and machine learning. The second volume comprises an extensive set of refreshed case studies spanning laboratory, manufacturing and supply chain systems with new contributions on databases, spreadsheets, LIMS, blockchain, mobile devices, AI-enabled systems, big data and digital twins authored by various industry experts.
Key Features
- Covers governance framework, roles and responsibilities, quality culture, project lifecycle, operational compliance, risk management, electronic records/signatures, supplier management, practical troubleshooting, handling regulatory inspections, metrics, and the opportunity for performance improvement
- Provides a set of 22 new and updated case studies by industry experts, demonstrating how these computer system validation principles are put into practice
- Focuses on GxP regulatory requirements covering GCPs, GLPs, GMPs, and GDPs—complete with observations from inspections by the US FDA and other regulators
- Discusses industry regulations and guidance, including current thinking of the US FDA on computer software assurance, the latest guidance from the US FDA/EU/MHRA on data integrity, and the newly published ISPE GAMP 5 Guide (Second Edition)
- Shares the practical experience and advice from a group of leading computer validation and compliance international experts
Shipping & Processing
This item is in stock with our supplier and usually ships within 2–5 business days.
Processing times
- In stock: Items marked “In Stock” are on our shelves. We pick, pack and ship them within 1–2 business days.
- In stock with our supplier: Items not marked “In Stock” are held by one of our Australian or overseas suppliers. We order them in for you and they usually dispatch within 2–5 business days (3–5 for some suppliers). The estimate next to the price is for this item.
- Special orders: Some supplier items, such as specialist and imported items, titles awaiting reprint and print-on-demand titles, take longer to arrive. If your order includes one, we’ll update you as soon as we hear from our supplier.
- Supplier delays: Occasionally a supplier is delayed, or their stock information turns out to be inaccurate. We’ll keep your order open for up to 60 days. If an item hasn’t shipped or isn’t on its way to us by then, we’ll cancel that item and refund it.
How accurate is availability?
Availability is based on the stock levels our suppliers tell us they hold, and we update it regularly. If a supplier issue affects your order, we’ll let you know with an updated estimate.
Delivery
- As soon as your order ships you’ll get an email with tracking.
- Australia Post usually delivers within 2–10 business days of shipping (around 4 in metro areas and around 6 in regional areas).
- If your order has more than one item, we hold the in-stock items until everything is ready, so we can ship your whole order together in one parcel.
- Shipping cost: Free on orders over $100 within Australia, otherwise $9.95 flat rate per order however many items you buy. Free shipping applies to Australian addresses only; delivery to New Zealand is $14.95 per order.
- Check your address: If an order goes to an incorrect address you gave us, or isn’t collected and Australia Post returns it to us, you’ll need to pay the postage to send it again.
Cancellations
Need to change or cancel an order? Contact us as soon as possible at contact@bookloop.com.au or through our contact page.
- Within 30 minutes: You can change or cancel your order for a full refund within 30 minutes of placing it.
- After 30 minutes: Your order is already being processed, so it can no longer be changed or cancelled. If we can accept a late cancellation, we may offer store credit instead of a refund.
- Items in transit: Once an item is on its way, either from our supplier to us or from us to you, it can’t be cancelled. If you no longer want it once it arrives, you can return it as a change of mind, with return postage at your cost. See Returns.
- Separate orders can’t be combined once they’ve been placed, and adding or swapping items can change the delivery estimate.
- Supplier delays: Occasionally a supplier is delayed, or their stock information turns out to be inaccurate. We’ll keep your order open for up to 60 days. If an item hasn’t shipped or isn’t on its way to us by then, we’ll cancel that item and refund it.
Faulty or damaged items are always covered. See Returns.
Returns
Damaged or incorrect items (within 30 days)
If an item arrives damaged or isn’t what you ordered, contact us within 30 days of delivery. We may ask for a photo, and if we need the item back we’ll send a prepaid return label, so it costs you nothing. You’ll receive a replacement or refund, as guaranteed under the Australian Consumer Law.
Change of mind (within 30 days)
We offer a refund or store credit for change of mind within 30 days of purchase when:
- you have your proof of purchase;
- the item is unused and in its original condition and packaging;
- it isn’t a sale item, special order, custom item or gift voucher.
You pay the postage to return change-of-mind items. Change-of-mind returns aren’t available for print-on-demand titles or bulk orders with special pricing.
Returned to sender
If an order is sent to an incorrect address you gave us, or isn’t collected and Australia Post returns it to us, you’ll need to pay the postage to send it again.