Rosemont Pharmaceutical

Document control and the requirements of 21CFR Part 11

Rosemont Pharmaceuticals have developed over 90 oral liquid formulations of medicines, successfully positioning itself as ‘The Specialists in Oral Liquid Medicines’. Rosemont’s manufacturing facilities are built for the production of oral liquid preparations from simple liquids through to suspensions covering a broad range of therapeutic areas. These liquids are used to treat patients who, either because of medical conditions or personal preference, take their medication in oral liquid form.

Following the guidelines of the FDA’s 21 CFR Part 11, Rosemont have approximately 4000 controlled documents ranging from methods of manufacture, to standard operating procedures. Through documenting a vast amount of information from other sources, the number of documents requiring control at Rosemont is always rising, along with an increase in the different types of documents, such as engineering drawings.

Rosemont Pharmaceuticals were therefore seeking a cost effective way of controlling the creation, modification, issue and expiry of documents within their organisation. They also wanted to make company knowledge easily available to the appropriate staff, and replace the databases where the data was fairly static.

John Wyke at Rosemont, therefore began looking at a number of software solutions that would help the company achieve these goals. Operating in quite a high margin, many of the software solutions that were advertised as specifically pharmaceutical would satisfy their requirements, but at quite a high price. The competitive pricing of the Powerway solution, coupled with the fact that Powerway offers a range of solutions in a variety of modules, meant that Rosemont could deploy a cost effective solution that would meet their current requirements, and potentially assist them in other areas at a later time.

“The modular nature of the system means that we validated the base functionality and document management functions,” remarks John. “We can then add other modules as we need, validating the additional functions as we go.”

Rosemont will be using the system in a heavily prescribed manner for their GMP documentation. John believes that the Powerway solution will save time, and therefore money, in document reviews, the maintenance of their paper documents, and locating the information that their employees need. Once the non-GMP side of the system is also deployed, and departments are responsible for their own documentation, John believes that further time and cost savings will be realised in the time taken to locate and retrieve vital information. John also believes that the Powerway solution will help Rosemont Pharmaceuticals move towards being a knowledge based organisation.

For pharmaceutical companies looking at document control solutions, the requirements of CFR 21 Part 11 are of vital importance. “Systems are not compliant with Part 11 out of the box,” says John, “they must provide the appropriate functionality to allow them to be used in a compliant manner.” To begin, the Powerway system was validated following the GAMP V model, and undertaking User Acceptance Testing which was linked to the User Requirements and included Part 11. All other requirements for validation were demonstrated during an audit at Powerway’s head office in Indianapolis.

The ability to generate accurate copies of records is a core functionality of the Powerway system, and the ability to set differing levels of authority will satisfy the requirements for using authority checks. Powerway also satisfies the limiting of system access by allowing six different access levels on a document-by-document basis, and prevents the approval of documents without first opening the document. Use of Powerway’s User Verification Utility, which prompts the user to re-enter their password upon approval further assures the use of operational checks to enforce sequencing.

Powerway also provides full document lifecycle management, including full history which retains previous draft and approved versions of all documents. Powerway’s Document Manager then assures that only the most current version of the document is available to users of the system. The security of Powerway on a qualified secure pharmaceutical IT network will then meet the ‘Protection of Records’ requirements of Part 11. Finally, Powerway demonstrated the ability for full training of the solution, allowing Rosemont to ensure appropriate training and experience for all users of the Powerway system.

For all organisations looking at software to help improve their document control, it is essential that the solution is easy for employees to use. One of the appeals of Powerway to John Wyke was the simplicity of the Powerway interface:

“It was an easy sell to people who are wary of anything more complicated that Microsoft Word as there aren’t many buttons or options for them. They get documents; they get what they need to see; they get told when it’s updated. They can find things easily, and that’s the biggest selling point of the Powerway system.”

Rosemont Pharmaceuticals Ltd. is a leading developer, manufacturer and marketer of high quality oral liquid medicines. Based in Leeds, West Yorkshire, Rosemont employs approximately 130 people. It is a UK based, pharmaceutical subsidiary of the NASDAQ listed company, SAVIENT Pharmaceuticals Inc.