In order to solely focus on core competencies and reduce the cost of overhead and labor, many medical and pharmaceutical companies outsource their functions to contract manufacturers, testing laboratories, and research organizations. One of the goals for these contract organizations is to automate the document control processes and incorporate Current Good Manufacturing Practice regulations in the system. MasterControl’s CRO document control software provides contract organizations with the ability to automate the document control and quality process functions outsourced to them by helping in aligning all documents in accordance with the way procedures are performed.
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When a life science company transfers a function to a contract organization, the CRO becomes subject to the same regulatory action as its client. Document control becomes as important to contract organizations as it is to the sponsoring companies. Organizations contracted by pharmaceuticals are covered by 21 CFR Parts 210-211, while those working for medical device companies are covered by 21 CFR Part 820. CRO document control software meets government requirements for a quality system with written procedures; deviations from quality procedures must be justified and documented.
21 CFR Part 11 works in tandem with predicate rules such as 21 CFR 210-211 and 21 CFR 820. Part 11 also requires document control procedures. The importance of document control in FDA compliance is undeniable. To control quality, one must require an effective contract organization document control software system.
With the MasterControl contract organization document control software, you can be sure to promote quality control and practice CGMPs. One objective of any CRO is to automate the way processes are carried out on behalf of its clients. MasterControl provides contract organization document control software that helps contract organizations attain and sustain CGMP compliance for document procedure control requirements. In order to be 21 CFR Part 11 compliant, CRO’s using software solutions must keep them in a constant state of validation. This ensures that the company is able to sustain FDA compliance. MasterControl’s CRO document control software offers comprehensive, full-cycle validation, including IQ, OQ, and PQ validation tests. The time involved in validating the system as well the ease of validating software upgrades is an essential factor in selecting a document quality management system. MasterControl provides CROs with the instruction and the tools to validate the software and reduce the time it takes to validate software upgrades.
In the short run, companies with multiple facilities and employees in different locations may find it cheaper initially to maintain separate quality CRO systems, especially paper-based or hybrid document control systems. However, in the long run it has been proven that such systems are not tenable because maintenance of documents in such systems require intensive attention. Operations such as documenting SOPs, obtaining approval and signatures, face-to-face meetings to discuss changes, and manual search and retrieval of documents during FDA inspections or quality audits can be a cumbersome and time consuming task.
MasterControl’s CRO document control system is an online centralized repository that provides document access to authorized users. Irrespective of the document format, the repository is able to manage the documentation for the organization. The searching, retrieving and updating of documents are simplified with the concept of the virtual vault. The vault allows users to view and update the documentation in the repository from any location across the globe.
With the huge number of documents encompassing SOPs, policies and other documentation in the system, it can be difficult to keep track of all the documentation activity. How can you keep an eye on a document that is being currently updated? What if its previous version is already being used for manufacturing a product batch? How long would it take to receive approval for a document? These questions address the basic problems that many CROs face in paper-based or hybrid-systems. The answer lies in moving towards a contract organization document control system that allows automatic revision control.
MasterControl’s CRO document control software enables the contract organizations to bring order in the system. Only the current version of a document is available. Changes can be initiated and approved electronically. When a user makes a change, the user must enter a reason for the change. The system tracks these changes and makes them available through reports. MasterControl Documents always ensures users the ability to access the right document any time and simply allows users to access advanced contract organization document control from virtually anywhere in the world.
Depending on disparate tools and processes is a mistake CROs can make. In order to keep the processes executing smoothly in the system, communication between various departments plays a vital role. It is of extreme importance to avoid any kind of miscommunication in enacting any procedure as it may lead to severe consequences such as delays in production, poor batch production, damage to human life, shuttering the contract organization, etc. It is important to keep the channels of communication open and transparent to avoid these pitfalls.
MasterControl Documents is an integrated solution that can connect all quality subsystems such as CAPA, change management, audit, customer complaints, and training. For example, a customer complaint that warrants a CAPA will be immediately escalated. Any CAPA that results into a change will automatically invoke training once the change is approved. Contract organization document control software plus quality process automation is a powerful combination.
Recent trends have brought to focus the importance of generating accurate and timely reports. Most of the CROs rely on disparate tools such as electronic spreadsheets, flowcharting software, paper documents in binders, etc, to generate reports. These tools are not sufficient in presenting managers an accurate picture of their quality management system.
MasterControl contract organization document control software comprises of advanced analytics and reporting capability, including customizable reports and online charting. Through the reports, managers get a real-time view of the quality processes and can be more proactive about improving their quality system.
Some miscellaneous facts related to MasterControl’s control organization document control systems include:
For more information about online document management, and Contract Organization (CRO) Document Control Software Systems, please feel free to contact a MasterControl representative.