| Simply put, change control is the way that | | | | confident that their change control process works. |
| pharmaceutical, life science and technology companies | | | | Why? Because their change control software system |
| (or any company for that matter) handle set-backs, | | | | allows them to completely control their change control |
| "unpredictables" and upsets. Like people, companies | | | | process online while simultaneously meeting all |
| have distinct ways of dealing with challenges and | | | | regulatory standards (FDA, ISO, EMEA and |
| change. Some companies are calm......some have | | | | Sarbanes-Oxley compliance regulations). They can sit |
| nervous breakdowns. | | | | back and relax a bit because their change control |
| The question is this: How can your company avoid the | | | | process is connected. Their document management |
| change control breakdown? | | | | system is actually integrated with their change control |
| The Change Control Debate | | | | system and with their CAPA, audit, customer complaint |
| Some may say the key to good change control is a | | | | and training applications as well. Creation, routing and |
| good quality control department. Others might say that | | | | approval processes are all done electronically and/or |
| interpersonal communication is the key. | | | | automatically and are accompanied by version control |
| Perhaps their arguments are convincing but they've | | | | features which act as assurances for companies who |
| missed the big picture: change control software. | | | | want only the latest (and greatest) version of a |
| Change Control Software: Calm, Secure and | | | | document to be available for revision. With their |
| Streamlined | | | | change control software, company #2's records are |
| Effective change control software (yep, technology | | | | also archived for regulatory compliance. |
| wins again) is actually remaking change control | | | | Change Control Challenge Scenario #2: Subsequent |
| processes and giving some companies the "heads up" | | | | Training |
| on a calm and very streamlined change control | | | | The training procedures associated with change |
| process. | | | | control documentation and regulation make a |
| This article is designed to help companies see how the | | | | difference in every department from research to |
| "nervous breakdown" change control process and the | | | | production. Take a look at how two distinct companies |
| calm and collected change control process differ with | | | | manage their change control associated training. |
| the variance of only one factor: change control | | | | Company #1 |
| software. | | | | Company #1 decides that a paper based system is |
| Change Control Challenge Scenario #1: Communication | | | | the way to go. After hours of legwork and manual |
| Communication is obviously central to change control | | | | routing and approvals, the change control process is |
| processes. However, the way companies use | | | | "finished" (hopefully) and their documentation is |
| communication in relation to their change control | | | | delivered to the respective personnel who will |
| processes is not always commensurate with wisdom! | | | | implement it. Personnel members who receive the |
| Company #1 | | | | documentation however often fail to locate and |
| Company #1 decides to handle communication the | | | | destroy old versions of the new SOP (or related |
| paper-based way. Company #1 wants to save money | | | | document) and will likely be uninformed as to 1) |
| and to avoid the hassle of looking for effective change | | | | whether associated training is necessary for new |
| management software. Because their system is | | | | SOP procedures, 2) when and where the training will |
| paper-based the company does save money (at least | | | | occur and 3) whether any type of exam will be |
| at first) but company #1's employees also spend more | | | | required for the training to be completed. |
| time connecting processes that are naturally | | | | Company #2 |
| disconnected (such as electronic spreadsheets, email | | | | Company #2 is NOT sweating the small stuff. They |
| clients and outdated hard copy SOPs). Their creation, | | | | know their resultant SOPs will be automatically routed |
| routing and approval processes are manual (or hybrid) | | | | and approved by those persons specified during the |
| solutions and require that a lot of people waste a lot of | | | | set-up of their change control software. Applicable |
| time running around looking for the right people who | | | | personnel will also 1) be aware of any outdated |
| are often inconveniently away from their desks. This | | | | documents because those documents will either be |
| results in a lot of outdated SOPs floating around on | | | | electronically inaccessible or (for hard copies) be |
| production floors, uncertainty regarding which | | | | watermarked with appropriate dates, 2) will be |
| document versions are the most recent, and | | | | updated regarding whether or not training is necessary, |
| frustrations with the "ignorant" lack of accountability on | | | | 3) will be apprised as to when and where training will |
| the part of employees who are supposed to be an | | | | occur, and 4) will be provided with electronic quizzes or |
| essential part of the change control line up---not to | | | | exams if required for training procedures. |
| mention a variety of headaches. | | | | What are you waiting for? |
| Poor Company #1. It's about to have a nervous | | | | It's no wonder that some companies are walking |
| breakdown. | | | | through change control wonderland. They have |
| Company #2 | | | | access to viable change control software! Start |
| Company #2, on the other hand, is skipping gleefully | | | | searching for a flexible change control software |
| through the meadows of change control bliss. Okay, | | | | solution for your own company and save yourself a |
| so maybe they aren't skipping but at least they are | | | | change control breakdown. |